Cristina Saura graduated in Medicine at the Universitat de Barcelona (UB), in 2002 and carried out her training in Medical Oncology at the Vall d’Hebron University Hospital (HUVH), Barcelona. In 2007 she joined HUVH’s Medical Oncology Department directed by Josep Tabernero.
Cristina is Head of HUVH’s Breast Cancer Unit and Principal Investigator of VHIO’s Breast Cancer & Melanoma Group.
She presented her research sufficiency project: A programme for early detection of breast cancer in women with high risk: pilot monitoring experience with mammography and Breast MRI, in 2007 obtaining outstanding merit.
To pursue her interests in clinical research, Cristina joined the Program in Clinical Effectiveness at the Harvard School of Public Health in 2007. She obtained her PhD (Cum Laude) from the Autonomous University of Barcelona (UAB) in 2017 for her thesis entitled, Treatment of Breast Cancer diagnosed during pregnancy.
Cristina has participated as Principal Investigator and Co-Investigator in several breast cancer clinical trials. She is actively involved in developing various international studies involving drugs directed against molecular targets in breast cancer. She is especially dedicated to advancing precision oncology and has become a reference in the development of different PI3K inhibitors and anti-HER2 therapies. She is the author of various publications as well as communications at national and international congresses.
Cristina also serves on the Scientific Committee and Board of Directors of the SOLTI academic research group in breast cancer, and is a Member of the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), the Spanish Association of Medical Oncology (SEOM), and GEICAM (Spanish Breast Cancer Research Group).
In 2018, she was awarded with the PERIS recognition by the Generalitat de Catalunya in its strategic plan for research and innovation in health for the project entitled, Precision medicine in metastatic breast cancer: determination of mutations in tumors and circulating tumor ctDNA as tools to guide the treatment of patients with metastatic breast cancer.
The main area of expertise of the Breast Cancer Group led by Cristina Saura is clinical research focused on drug development and associated translational research. In addition to high patient recruitment in our studies maintained even the challenging scenario of the Covid-19 pandemic, we also play a leading role in many of the clinical trials that we run. This enables us to have a direct impact in applying translational data to guide and accelerate drug development:
We focus on proof-of-concept and proof-of-mechanism trials with targeted therapies, with particular emphasis on cell signaling, cancer stem cells, and immuno- oncology. These include first-in-human studies of targeted therapies, rational combinations of targeted therapies, biomarker-driven trials, and studies in molecularly selected populations.
We link clinical research at the Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, with different areas of investigation carried out at VHIO, following a truly translational model. For selected projects, we match molecular biology and optimal tumor models with pharmacology and innovative clinical research by involving VHIO scientists in our trials (biomarker development, profound understanding of mechanisms of action and resistance).
We participate in VHIO’s Molecular Prescreening Program to perform molecular analysis of patients’ tumors. This enables us to select the optimal treatment for our patients with the experimental therapies available in our portfolio of clinical trials.
Importantly, in relation to precision oncology, VHIO is a founding member of both the WIN (Worldwide Innovative Networking in personalized cancer medicine), and the Cancer Core Europe (CCE), consortia. Both are non-governmental organizations that connect international (WIN) and/or European (CCE) cancer centers, including VHIO, to advance cancer diagnostics and therapeutics.
This year, our group and VHIO’s UITM – CaixaResearch, have continued to lead the Basket of Baskets (BoB) trial. This academic study, endorsed by Cancer Core Europe, integrates molecular prescreening, the development of new diagnostic tests such as circulating DNA, with the assessment of targeted therapies in populations of patients who, matched to specific molecular alterations, will be most likely to benefit from these treatments. During this year we have continued to search for funding to add new modules.
We have been working in the EU-funded Cancer Core Europe Consortium-Building Data Rich Clinical Trials (CCE-DART) project. By harnessing and incorporating powerful cutting-edge technologies, methods and platforms, CCE-DART investigators will spur the design, development, and ringing in of a new generation of data rich, dynamic studies in oncology in the next years to come.
Our Early Drug Development Group and Phase I Unit - UITM – CaixaResearch - continues to establish VHIO as a leading reference in driving drug development and targeted therapies in oncology. Testament to this is the number of patients who entrust us with their care (521 patients enrolled in phase I and basket studies in 2020), the portfolio of different trials available (195 phase I trials including 22 basket studies in 2020), and the novelty of our programs in precision medicine and immunotherapy drug development. This is also evidenced by our leading role in Cancer Core Europe’s Clinical Trials Task Force.
Our CaixaResearch Advanced Oncology Research Program, continues to expand. This year we have collaborated with Alena Gros to complete the preclinical work to generate the first VHIO TIL therapy, NEXTGEN- TIL, and have secured funding to start the trial next year, in 2021.
We have also fostered important alliances with the pharmaceutical industry and collaborate closely with other clinical research organizations and academic centers of excellence, as well as companies dedicated to advancing personalized cancer medicine and care.
Francesc Bosch is Principal Investigator of VHIO’s Experimental Hematology Group, Professor of Hematology and Head of the Department of Hematology of the Vall d’Hebron University Hospital (HUVH), Barcelona.
He graduated from the Universitat de Barcelona (UAB) Medical School in 1988, and from 1989 – 1992 he carried out his training as a Resident in hematology at the Hospital Clínic in Barcelona. In 1997 Francesc was awarded his PhD by the UAB for his research centering on the over-expression of Cyclin D1 in chronic lymphoproliferative disorders under the supervision of Elias Campo. He subsequently carried out a two-year postdoctoral stay in the laboratory of Riccardo Dalla-Favera at the Institute of Cancer Genetics, Columbia University, New York (USA).
He then returned to the Hospital Clínic in the year 2000 where he continued to study CLL, and was later appointed as Head of the Department of Hematology and Director of the Experimental Hematology Laboratory at the Vall d´Hebron University Hospital in September 2009. He conducts both clinical and basic research in CLL and other lymphoproliferative disorders, with particular focus on the molecular pathogenesis of CLL and the development of novel therapeutic approaches.
Since 1995 he has been involved in the development of clinical trials in CLL and has made seminal contributions in the prognosis, assessment and treatment of CLL. He is also Chair of the Spanish CLL Working Group (GELLC) which leads the development of CLL clinical trials across Spain. Francesc has published over 100 papers in several peer-reviewed journals including those with the highest-impact factors such as The New England Journal of Medicine, Nature Medicine, Cancer Cell, Blood, Journal of Clinical Oncology, and Leukemia. In addition, he has authored or co-authored several Reviews and Book Chapters on CLL and other lymphoproliferative disorders.
VHIO’s Experimental Hematology Group conducts translational, pre-clinical and clinical research on hematological neoplasms of both lymphoid and myeloid origin. Our research team is composed of hematologists and biological scientists who work closely together to design, conduct and lead our programs.
Our projects are always based on the unmet medical needs identified by hematologists, with the ultimate goal of translating our results to patients by developing early phase clinical trials and defining novel biomarkers to improve diagnosis, prognosis and outcomes.
We aim to provide new therapeutic options for our patients by deciphering the mechanisms involved in the pathogenesis and progression of hematological malignancies. We also conduct pre-clinical studies of new therapeutic proposals for patients diagnosed with hematological malignancies. Our group fosters the definition of new biomarkers in hematology that will lead to a more rational and precise diagnosis, prognosis and treatment of our patients.
Finally, our Hematology Clinical Trials Unit is currently participating in more than 120 clinical studies, including phase I clinical trials (n=39) and first-in- human studies of targeted therapies, both in lymphoid and myeloid malignancies. Last year 153 patients were included in our clinical studies, with 56 patients enrolled in phase I studies.
Areas of Research
Prizes and Scholarships
VHIO’s Gastrointestinal & Endocrine Tumors Group continues to play an essential role in developing molecular therapies against GI malignancies. We make important contributions to advancing insights into prognostic and predictive factors of response and potentiating precision medicine in oncology.
Our group pioneers transformative research of excellence and leads early phase clinical trials aimed at potentiating novel anti-cancer therapies, either as monotherapy or in combination, together with translational studies for biomarker analysis.
Importantly, we co-designed and led the BEACON study. Results showed that the doublet combination of a BRAF inhibitor and an EGFR inhibitor, improves overall survival and also increases objective response rates compared to standard of care in patients with BRAF V600E-mutant mCRC.
We have also made significant progress in validating and developing liquid biopsy technologies for the more effective, less invasive monitoring of cancer in real time. Moreover, our research has shown that genomic and transcriptomic profiling are both useful in guiding the more precise selection of therapies toward improved clinical outcomes for patients.
Our truly multidisciplinary team incorporates medical oncologists and clinical investigators, a translational researcher with expertise in biomarker discovery, a research nurse dedicated to monitoring patients in research programs, laboratory technicians specialized in molecular biology and patient-derived xenografts (PDX), data curators, as well as other professionals involved in the study of precision medicine against GI malignancies. We also work in close collaboration with other VHIO researchers and groups through our highly interactive and functional Task Forces in colorectal and pancreatic cancers.
We have also participated in KEYNOTE-177; one of the highlighted studies featuring in Josep Tabernero’s foreword to this year’s report. The particular relevance of this study is that, for the very first time, the administration of immunotherapy as monotherapy has demonstrated superiority to standard of care in the first-line treatment of metastatic colorectal cancer.
Presented during the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO), and published in the New England Journal of Medicine (André T, Shiu KK, Kim TW, et al. N Engl J Med. 2020) results of this study could lead to paradigm shift in the treatment of these patients.
During 2020, the European Horizon 2020-supported NoCanTher Consortium reached a major milestone. Launched back in 2016, this project is powered by eleven European partners, including VHIO. Specifically, we completed work to initiate the project’s clinical study and subsequently received approval from the necessary regulatory bodies. Leading the assessment and clinical development of magnetic nanoparticles for the treatment of locally advanced pancreatic cancer, this is the first time that this novel approach will be tested in the clinical setting.
Also, in pancreatic cancer, a novel strategy combining immunotherapy and chemotherapy for the treatment of metastatic disease has shown promising results. Data from the COMBAT trial suggest that the addition of chemotherapy could potentiate immunotherapy, which, up until now, has not been effective in treating pancreatic cancer.
The COMBAT investigators combined pembrolizumab that binds to and blocks PD-1 located on lymphocytes to help the immune system destroy cancer cells, with BL-8040, a CXCR4 antagonist, that enhances tumor T cell infiltration.
Finally, we received European Neuroendocrine Tumor Society (ENETS) Certification for excellence in treating neuroendocrine tumors. As the first Unit to do so in Spain, this accreditation jointly recognizes the Vall d’Hebron University Hospital and VHIO.
Joan Carles received his MD degree in Medicine and Surgery in 1987 from the Universidad de Barcelona (UAB), from where he later obtained his PhD in 1992. He completed his specialty training in Medical Oncology at the Hospital Universitario Germans Trias i Pujol in Badalona (Barcelona), and in 1996 received the European Certificate in Medical Oncology in Wien.
In 1991 he joined the Medical Oncology Unit at the Hospital de Terrassa and from April 1992 to September 2008, he was a Medical Oncologist at the Hospital del Mar, Barcelona. Joan joined the Medical Oncology Department at the Vall d’Hebron University Hospital (HUVH) in September 2008, and currently serves as Principal Investigator of VHIO’s Genitourinary, CNS Tumors, Sarcoma & Cancer of Unknown Primary Site Group.
He is Co-Founder of the Spanish Society for the Treatment of Genitourinary Cancer (SOGUG), for which he was appointed as Secretary and Vice-President in 1999 and 2012 respectively. He is also member of the Spanish Sarcoma Research Group (GEIS). Since 1995, he has continued to serve as part-time Professor of Medicine at the Universidad Autónoma de Barcelona where he is also Coordinator of the Medical Oncology training program.
He has authored more than 130 articles and delivered more than 375 presentations at congresses and meetings of excellence. He is also Author of several book chapters.
Joan’s research interests surround clinical genitourinary oncology, sarcoma and early and translational clinical research in angiogenesis as well as immunotherapy and targets in cancer therapy. He also coordinates multicenter as well as national clinical trials for new drugs aimed against prostate, kidney and bladder cancers.
In addition, he is Member of the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), and the Spanish Association of Medical Oncology (SEOM). He acts as a Consultant in an advisory capacity for the preparation and development of oncology guidelines for the government of Catalunya (Oncoguies Catsalut). He has also been appointed as Consultant for national oncology grants from Spain, Italy, Switzerland, Ireland, and Finland.
We are dedicated to advancing clinical and translational research against cancer, with extensive experience and expertise in treating various neoplasms. We design and develop clinical trials for genitourinary malignancies at different stages of disease in collaboration with urologists and radiation therapists.
During 2020 we continued to consolidate our expert Prostate Task Force. By closely connecting clinical and translational researchers at VHIO and the Vall d’Hebron Research Institute (VHIR), we have initiated translational projects focused on prostate cancer. We are also doing the same for kidney cancer in pursuit of similar goals in collaboration with other partners including the Biomedical Research Institute of Bellvitge (IDIBELL).
Over recent years, several advances have been reported in the more effective treatment of GU malignancies. Immunotherapy (IO) is proving increasingly important against bladder and kidney cancers. Concerning the latter, immune-based therapies in combination with others, or paired with antiangiogenics, are considered the new standard treatments for first-line therapy.
In bladder cancer immunotherapy has also been shown as superior to chemotherapy in second line and in first-line for ineligible patients.It has recently been shown that immunotherapy as maintenance after 4/6 cycles of chemotherapy in first-line improves progression-free survival (PFS) and overall survival (OS).
Our group –along with others- has observed that immunotherapy could also be effective for certain subgroups of patients with castration-resistant prostate cancer. We are currently participating in phase I studies to assess immune-based cancer medicines for the treatment of this patient population.
We have also participated in various clinical trials using checkpoint inhibitors for the adjuvant treatment of bladder and kidney cancers with high risk of recurrence. Working closely with our Vall d’Hebron University Hospital’s Urology Department and other experts in high- risk tumors, we are currently running studies aimed at improving outcomes for patients with non-muscle- invasive bladder cancer.
We collaborate with various other renowned research centers including the Cleveland Clinic (Ohio, USA), University of California, San Francisco (California, USA). We also participate in studies carried out in partnership with the Gustave Roussy Institute (Paris, France), Barts Health NHS Trust – Hospital (London, UK), and Kantonsspital St. Gallen (Switzerland).
This year we have expanded our translational research program in prostate cancer working alongside VHIO’s Prostate Cancer Translational Research Group, led by Principal Investigator Joaquin Mateo.
Our main focus is metastatic castration-resistant prostate cancer and we are working on a project led by Joaquin, entitled: Clinical Qualification of DNA Repair Defects as Biomarkers in Metastatic Prostate Cancer Using Integrated Genomics and Tissue-Based Functional Assays. This research is supported by the US Department of Defense’s (DoD) Congressionally Directed Medical Research Program. Additionally, we are participating in the IRONMAN project lead by the Memorial Sloan Kettering Cancer Center (MSKCC – New York, USA). Led by VHIO, we collect patients’ reported outcomes in parallel with serum. This research is supported by Movember and the FERO Foundation.
We are also partnering with VHIO’s Radiomics Group headed by Raquel Perez-Lopez to analyze MRI alterations in patients who have started hormonal treatments for metastatic prostate cancer and correlate these data with bone biopsies performed in parallel.This project, iPROMET: a study for clinical validation of whole- body diffusion-weighed MRI as a response biomarker of bone metastases in patients with prostate cancer, counts on the combined expertise of a urologist, radio-oncologist, radiologist and medical oncologist to establish a circuit for the systematic metastatic tissue acquisition from prostate cancer patients at our Hospital.
We have also expanded our avatar program for kidney cancer tumors in collaboration with IDIBELL and implanted more than 35 samples. Additionally, we continue to participate in the REVOLUTION project, pREdiction of niVOLUmab acTION metastatic renal cancer patients: Treg function, tumoral access and NK interactions as predictive biomarkers of immunotherapy, supported by TRANSCAN-2 ERA-NET, under the scope of the EU Framework Programme Horizon 2020.
In collaboration with other professionals in neurosurgery and radiation therapy, we lead and develop several multidisciplinary clinical studies and phase I trials in CNS tumors. Additionally, it is thanks to a project with our Gene Expression & Cancer Group led by Joan Seoane that we continue to develop VHIO’s translational research platform for glioblastoma. We analyze cfDNA in blood and cephaloraquidic liquid for assessing primary CNS tumors and metastases.
Our group also participates in a project directed by the European Organisation for Research and Treatment of Cancer (EORTC, Brussels, Belgium), against several tumor types, working on CNS tumors: Cancer Patients for Efficient Clinical Trial Access (SPECTA). The main objective is to screen patients and develop academic clinical trials based on molecular stratification. This initiative is supported by the European Cancer Research Fund (ECRF) and Walgreens Boots Alliance (WBA). We are also active at the national level in a medulloblastoma platform to better define and classify these cancers.
We continue to work closely with the Spanish Sarcoma Group (GEIS) on clinical trials at different stages of disease with emphasis on a histology-tailored design and are currently setting up a translational platform for sarcomas and basic research in partnership with IDIBELL and the Cancer Research Center of Salamanca – CIC (Spain). For GIST tumors we are working with Jonathan Fletcher’s lab at the Brigham and Women’s Hospital (Boston, USA).
We are now recognized as a CSUR for the treatment of Sarcoma patients. This accreditation enables us to participate in the European References Network (ERN) for sarcoma tumors and other rare diseases.
In 2019, César Serrano he set up his own research group, VHIO’s Sarcoma Translational Research. During this year we have consolidated different clinical trials with new drugs in GIST by leading and participating in phase I-II-III studies. As this report went to print, one of these studies led to the U.S. Food and Drug Administration’s (FDA) January 2020 approval of Avapritinib for the treatment of adult patients harboring a platelet-derived growth factorreceptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.
Our Serum Bank now incorporates the majority of tumor types that we study (CNS tumors, GIST; renal cell carcinoma and CRPC), and we will continue to collect samples from our patients.
Dedicated to promoting education and exchange, in 2020 we welcomed six fellows from in (5) and outside (1) of Spain for three- month short stays.
Ana Oaknin graduated in Medicine and Surgery from the Universidad Complutense de Madrid in 1994, and specialized in Medical Oncology at the Hospital Universitario de La Princesa from 1996 – 2000. She then completed her training by academic rotations in the Breast Oncology Medical Department at the University of Texas, MD Anderson Cancer Center, Houston (Texas, USA), and later served as a Fellow at the Gynecological Oncology Department of the Memorial Sloan Kettering Cancer Center – MSKCC (NYC, USA), from 2003 -2004.
She has also worked at MD Anderson International in Madrid (2000 –2002), Instituto Oncológico Teknon – Teknon Institute of Oncology – Barcelona (Feb 2002 – Feb 2006), Instituto Catalán de Oncología (ICO)– Catalan Institute of Oncology – Barcelona, and Hospital Duran y Reynals, Hospitalet, Barcelona (2006 – 2008).
She is currently Principal Investigator of VHIO’s Gynecological Malignancies Group. She mainly focuses on clinical research and leads various phase I-II-III clinical studies at both the national and international levels. Her research centers on angiogenesis, immunotherapy and DNA repair mechanisms and she has also pioneered clinical trials with novel molecules that act on these molecular pathways that all assume crucial roles in the development and growth of gynecological tumors.
Ana is a distinguished member of cooperative groups including GEICO (Spanish Group for Investigation on Ovarian Cancer), GOG (Gynecologic Oncology Group) and GCIG (gynecologic Cancer InterGroup), and she is a Member of several leading scientific societies such as the American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), and the Spanish Society of Medical Oncology (SEOM).
Our clinical research group focuses on gynecological malignancies and the development of novel therapies against these tumor types. We are also members of some of the most relevant societies in gynecological oncology including the Gynecologic Cancer InterGroup (GCIG) for which we are appointed as the Spanish Representative serving on its Cervical Cancer and Phase II Trial Committees, the Gynecologic Oncology Group (GOG), as the Spanish clinical lead, as well as the European Network of Gynecological Oncology Trial Groups (ENGOT).
Our group contributes to the advancement of the treatment of gynecological malignancies. Over the past few years, we have participated in the development of a number of therapies that are now the current standard of care for different malignancies.
In 2020 we participated in several important clinical trials that have generated new and compelling data in gynecologic malignancies. As an example, we led the GARNET study. This trial includes the largest series of patients with endometrial cancer (EC) treated with immunotherapy; the anti-PD-1 agent, dostarlimab.
As this Scientific Report was being finalized, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion in February 2021, recommending dostarlimab for the treatment of patients with EC who have progressed to platinum therapy. Initial data that led to this approval was published in JAMA Oncology (Oaknin, A et al. JAMA Oncol. 2020).
While metastatic cervical cancer is a devastating disease, over recent years we have succeeded in expanding therapeutic approaches which have mainly been driven by immunotherapy. Moreover, we are working on other targeted agents such as neratinib that is showing promising results (Oaknin, A et al. Gynecol Oncol. 2020).
In addition, our Principal Investigator, Ana Oaknin, also serves on the Executive Board as Vice President for the Grupo Español de Investigación en Cáncer de Ovario – GEICO (the Spanish Ovarian Cancer Research Group); and as Faculty of the European Society for Medical Oncology’s (ESMO) Annual Meeting’s Gynecological Tumors Track, for which she was appointed as the Track Chair at the ESMO 2019 Congress, 27 September – 01 October (Barcelona, Spain), and Discussant of the Track’s Presidential Symposium during which, the results of two Phase III trials were presented. Most recently, at the beginning of 2021, she was appointed as a Subject Editor of ESMO’s Guidelines Committee.
Judith Balmaña is Principal Investigator of VHIO’s Hereditary Cancer Genetics Group and serves as Attending Physician for our Breast Cancer Unit, Medical Oncology Department of the Vall d’Hebron University Hospital (HUVH). She graduated in Medicine from the Universitat Autònoma de Barcelona (UAB), and carried out her residency in Medical Oncology at the Hospital Sant Pau, Barcelona. She was then awarded with a grant from “La Caixa” and trained as a Clinical Research Fellow in the High Risk Clinics for Breast and Colorectal Cancer at the Dana-Farber Cancer Institute, Boston (USA).
She was recently a Visiting Researcher at the Abramson Cancer Center, Philadelphia (USA), working on multigene panel testing for hereditary breast cancer. She was awarded her PhD from the Universitat Autònoma de Barcelona for her research on a prediction model for hereditary colorectal cancer.
Judith is member of the Sociedad Española de Oncología Médica (SEOM), for which she has served as a Board Member of the Hereditary Cancer Section, Associate Faculty Member of the European Society of Medical Oncology (ESMO), for which she is currently appointed as Coordinator of the Cancer Genetics Group (2017 – 2021), Clinical Coordinator and teacher for the Genetic Counselling Master’s Program (IDEC/UPF) at the Universitat Pompeu Fabra (UPF), teacher of hereditary cancer at Universitat Internacional de Catalunya (UIC), member of the SOLTI Cooperative Group as well as the American Society of Clinical Oncology (ASCO).
In 2005, she was appointed to set up the Vall d’Hebron University Hospital (HUVH) Medical Oncology Department’s Familial Cancer Program. Since then, she has been leading this program and serves as Attending Physician at HUVH’s Breast Cancer Unit. In 2016, Adrià López joined the group to research the psychological impact of multigene panel testing. In October 2018, VHIO’s Oncogenetics lab led by Sara Gutiérrez-Enríquez (formerly directed by Orland Díez), was incorporated within our group.
We focus on unravelling the challenges of implementing the advances in diagnosis of hereditary cancer susceptibility and translating insights into clinical practice. In collaboration with the hereditary cancer program at the Catalan Institute of Oncology (ICO) Judith obtained funding to investigate the genetic complexity of hereditary cancerthrough a multidimensional analysis of a customized panel,as well as the psychological impact in the population. Ongoing research is focused on the role of personality traits in predicting the psychological impact of genetic results and the uptake of prevention options.
A study to assess the genome-based cancer risk estimation and cancer-risk adapted strategies with the addition of polygenic risk score (PRS) analysis has just been funded. A longitudinal national-based registry of mutation carriers stores prospective data for health outcomes analysis.
Her interest in the genetic epidemiology of hereditary breast and ovarian cancer (HBOC) has resulted in a research collaboration with Sara Gutiérrez-Enríquez. This joint work has shed light on the characterization of new pathogenic variants in HBOC genes, and has provided discriminatory tools to interpret variants of uncertain significance in BRCA genes. We are interested in deciphering the role of intronic, splicing, and missense variants in major HBOC genes and investigating the yield of long-read RNA-seq in HBOC.
Sara Gutiérrez-Enríquez is also independently leading research into predictive genetic and cellular markers for susceptibility to radiotherapy-induced clinical toxicity. Her goal is to foster her independent research lines and ultimately become a group leader at VHIO.
With the discovery of PARP inhibitors, Judith became deeply involved in their clinical development as targeted therapy for patients with a BRCA1/2mutation. She has actively collaborated in phase I-III clinical trials with PARPi/other DNA-damaging agents targeting tumors with a BRCA deficiency. In 2012, she joined forces with Violeta Serra, Principal Investigator of VHIO’s Experimental Therapies Group to initiate and co-lead research aimed at identifying mechanisms of resistance to PARPi in breast cancers from BRCA1/2-mutation carriers (see Violeta’s group tab under Programs & Groups > Preclinical & Translational Groups of this Scientific Report).
Judith Balmaña is ad-hoc reviewer for several international journals in oncology, and has published more than 146 papers in national and international biomedical publications of excellence.
We focus on the clinical development of PARP inhibitors (PARPi) in early gBRCA1/2 breast cancer, and novel combinations in the advanced setting. The consolidation of our collaboration with VHIO’s Experimental Therapeutics Group, led by Violeta Serra, has resulted in a large collection of BRCA1/2-associated patient-derived xenografts (PDX) implanted in athymic mice. We are using these murine models to identify mechanisms of resistance to targeted therapies, identify novel biomarkers, and assess new combinatorial treatments at progression. We have identified a functional biomarker for PARPi sensitivity that has been tested preclinically and in human samples, and are now collecting samples for a larger clinical validation.
Our group is also interested in unravelling the challenges of implementing the advances in diagnosis of hereditary cancer susceptibility and applying these insights to clinical practice. In partnership with the hereditary cancer program at the Catalan Institute of Oncology (ICO), we are investigating the genetic complexity of hereditary cancer through the multidimensional analysis of a customized panel, as well as the psychological impact in our population.
Ongoing research centers on the role of personality traits in predicting the psychological impact of genetic results and the uptake of prevention strategies. We have received funding to assess genome- based cancer risk estimation and cancer-risk adapted approaches incorporating polygenic risk score (PRS) analysis. A longitudinal national-based registry of mutation carriers incorporates prospective data for the analysis of health outcomes.
We pursue our interest in the genetic epidemiology of hereditary breast and ovarian cancer (HBOC), led by one of our Senior Scientists, Sara Gutiérrez-Enríquez. This research has shed important light on the characterization of new pathogenic variants in HBOC genes, and provided discriminatory tools to interpret variants of uncertain significance in BRCA genes. We are devoted to deciphering the role of intronic, splicing, and missense variants in major HBOC genes and investigate the yield of long-read RNA-seq. Sara Gutiérrez-Enríquez is also independently leading research into predictive genetic and cellular markers for susceptibility to radiotherapy-induced clinical toxicity.
Rodrigo Dienstmann is a medical oncologist with expertise in clinical and translational research. After graduating in Brazil, he moved to Spain for training in the phase I development of cancer drugs. He helped develop a molecular prescreening strategy to match the genomic profile of each patient’s tumor to targeted agents, the central dogma of precision oncology.
During his post-graduation at the Massachusetts General Hospital (Boston, USA), he provided standardized decision support with structured reports of the next-generation sequencing tests performed in the clinical lab. By designing the framework for variant annotation, prioritization and interpretation, together with a comprehensive gene-drug knowledge database of predictive genomic biomarkers in solid tumors, he played a central role in the process of clinically implementing these tests.
He then assisted the Sage Bionetworks Computational Oncology team (Seattle, USA), in the development of novel predictive and prognostic models using cancer genomics data and was deeply involved in the Colorectal Cancer Subtyping Consortium, which resulted in the identification and characterization of the intrinsic disease subtypes.
He is now Principal Investigator of the Oncology Data Science Group and a coordinator of the Molecular Prescreening Program of the Vall d’Hebron Institute of Oncology, integrating clinical and translational research with multi-omics for precision cancer therapy and biomarker validation studies.
VHIO's ODysSey Group promotes translational research in precision oncology by integrating cancer molecular profiling data with clinical outcomes of oncology patients treated at the Vall d’Hebron University Hospital (HUVH).
To analyze big and real-world data, we design and maintain comprehensive clinical-molecular databases and develop customized decision-support systems to researchers who have an interest in correlative analyses for hypothesis- generation and biomarker validation. We also provide assistance to investigators for the calculation of sample size, clinical trial design, and downstream statistical analyses.
Our team also participates in international multi-omic data analyses projects and fosters collaborative research in computational oncology. We are dedicated to connecting cancer researchers working on predictive and prognostic modelling, the identification of cancer drivers, molecular subtyping, primary-metastasis heterogeneity, microenvironment signatures and druggability in solid tumors.
In collaboration with Susana Aguilar, Jennifer Gonzalez, and VHIO's Cancer Genomics Group led by Ana Vivancos, Molecular Oncology Group, directed by Paolo Nuciforo, and Elena Garralda, PI of our Early Clinical Drug Development Group, and Director of VHIO's Research Unit for Molecular Therapy of Cancer (UITM) - CaixaResearch, we co-lead VHIO's in-house Molecular Prescreening Program.
We have performed tumor molecular profiling in over 1,100 cancer patients as candidates for enrollment in clinical trials. In total, 151 patients were treated with biomarker-matched innovative therapies as a result of this effort.
Interpretation of next-generation sequencing tests and educating clinicians on emerging biomarkers is another of our priority areas, and genetic counseling alerts in case of pathogenic germline variants. During Molecular Tumor Board meetings, we promote precision oncology by providing guidance regarding inclusion in early clinical trials with biomarker-guided targeted agents or immunotherapies, and genetic counseling alerts in case of pathogenic germline variants.
Jordi Giralt is Principal Investigator of the Radiation Oncology Group at the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, Head of the Radiation Oncology Department at the Vall d’Hebron University Hospital (HUVH), and Professor in Radiation Oncology at the Universitat Autònoma de Barcelona (UAB). He is actively involved in translational research and technology development, with particular focus on EGFR-family as well as dose escalation programs in head and neck cancer. He is the head of the GEORCC (Spanish Group of Radiotion Oncology for Head and Neck Cancer.
He received his medical degree from the Universitat Autònoma de Barcelona and completed his specialist training in radiation oncology. He is a member of the European Society for Radiotherapy & Oncology (ESTRO), Pediatric Radiation Oncology Society (PROS), and the AmericanSociety of Radiation Oncology (ASTRO).
Jordi also serves on several Editorial Boards including those of Frontiers in Oncology,Oral Oncology, and Clinical Translational Oncology, and has (co) authored over 90 peer-reviewed papers. He has also been a member of Educational and Scientific Committees of the ESTRO, ECCO and PROS congresses and meetings.
Our group is integrated within the Radiation Oncology Department of the Vall d’Hebron University Hospital (HUVH), and focuses on the multidisciplinary treatment of patients with malignant tumors. We also participate either as Principal Investigators or research collaborators in a number of pioneering clinical trials, translational research projects, as well as technology development programs.
In 2020 we have renewed three linacs thanks to a donation received from the Amancio Ortega Foundation. The machines incorporate all the very latest technology and the implementation of these highly complex techniques requires additional expertise from our service as well as specialized trainings for indications, administration procedures, quality control methods, as well as the incorporation of novel tools and approaches for the measurement of results.
Raquel Perez-Lopez attended Medical School at the Universitat de Barcelona and went on to complete her specialty training in Radiology at the Bellvitge University Hospital, Barcelona. During her residency, she completed a Masters in Clinical Sciences studying perfusion MRI in patients with high-grade astrocytoma.
Supported by the European Society of Radiology (ESR), a clinical fellowship then led her to the Royal London Hospital – Barts Health NHS Trust, followed by her move to the Institute of Cancer Research and Royal Marsden, London (UK), where her PhD focused on the study of bone metastases from prostate cancer by diffusion-weighted MRI.
These studies enabled her to identify the value of whole-body diffusion-weighted MRI as a prognostic and response biomarker of bone metastases in prostate which in turn led to the completion of the first prospective clinical trial in this context. Importantly, this work resulted in over fifteen manuscripts that she first or co-authored in prestigious titles including The New England Journal of Medicine, Cell, Cancer Discovery, and Radiology.
Raquel joined VHIO in the autumn of 2017 as Principal Investigator of its Radiomics Group. Her research focuses on functional CT and MRI techniques such as perfusion, diffusion and spectroscopy to better identify histological and molecular characteristics of tumors. In 2018 her group was awarded with an Institute of Health Carlos III (ISCIII) Program grant and Raquel received a Young Investigator Award from the Prostate Cancer Foundation (PCF).
Complementing other preclinical and clinical research lines at VHIO, her group seeks to optimize drug development by more effectively characterizing the antitumor effect of novel agents (including immunotherapies), identify those patients who are most likely to benefit from these therapies, and also support VHIO´s translational research lines in genomics, predictive science, and biomarkers of response and resistance.
Our Radiomics Group keeps growing; in 2020 Aina de Torner joined us to carry out her end-of-degree research project on CT-radiomics towards optimizing patient selection for immunotherapy in a selected population of lung cancer. Francesco Grussu also joined the team as our new Post-Doctoral Scientist. We are also pleased to announce that we are currently recruiting for additional new talents.
Over the past year, we have fostered further collaborations with additional leading imaging research groups including the Computing Vision Centre (CVC–Universitat Autónoma de Barcelona), and cutting-edge research centers including the Bellvitge Institute for Biomedical Research (IDIBELL), in Barcelona, the Netherlands Cancer Institute (NKI), Amsterdam, and the Cancer Research UK (CRUK) Cambridge Institute. In partnership, we have designed various projects for which we have applied for funding through national and international grants.
Continuing our collaboration with VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch led by Elena Garralda, we have developed a CT-radiomics signature in order to better characterize response to immunotherapy (published in Radiology). Thanks to the support received through an AstraZeneca Proof of Concept Award, we have recently initiated the first prospective study of CT and multiparametric MRI-radiomics to quantify changes in tumor cellularity and vascularization as a biomarker of response to immune checkpoint inhibitors.
We are also delighted to report that the CRIS Cancer Foundation has awarded Raquel Perez-Lopez with a Research Talent Award. This will fuel her research aimed at improving cancer patient selection for immunotherapy and better understanding differential responses to immune-checkpoint inhibitors. We are also very grateful to the FERO Foundation for its support that will enable us to apply deep-learning models to medical imaging for a deeper understanding of tumor immunophenotypes.
We are also exploring new diffusion-weighted MRI protocols to evaluate biological-specific metrics regarding tissue cellularity and cell-size in the liver. We envision the metrics derived from this new assay will have crucial applications as non-invasive biomarkers in cancer.
Thanks to the support received from the Carlos III Institute of Health (ISCIII) and the Prostate Cancer Foundation Young Investigator Award, our group coordinates a multi-center prospective study of whole-body diffusion-weighted MRI as a response biomarker of bone metastasis in prostate cancer patients. This study has recently expanded to include breast cancer patients thanks to funding from La Fundació La Marato de TV3 (PreciMet study).
Our group has established interdisciplinary partnerships with various VHIO groups to work together on several translational research projects. Our ethos of team science is key to optimizing imaging and accelerating translational research against cancer.
Focused on applying imaging biomarkers and radiomics to cancer discovery, our efforts center on advancing precision imaging in personalized medicine to ultimately improve outcomes for cancer patients.
Enriqueta Felip is Principal Investigator of VHIO’s Thoracic Cancer Group, within the Oncology Department of the Vall d’Hebron University Hospital (HUVH). Enriqueta Felip received her medical degree from the Universitat Autònoma de Barcelona, where she also completed her PhD studies in medical oncology. She is a Professor of Medicine at the Universitat de Vic – Universitat Central de Catalunya (UVic-UCC).
Enriqueta heads the management of thoracic cancer patients and is also responsible for lung cancer trials led by the Vall d´Hebron University Hospital’s (HUVH) Oncology Department. Current research lines include the optimization of chemotherapy in early-stage disease, evaluation of new agents and therapies, research into novel pharmacogenomic approaches, and the integration of immunotherapeutic approaches in the treatment of lung cancer patients, and the elucidation of potential mechanisms of resistance to tyrosine-kinase inhibitors.
In 2017 she was elected as Member of Foundation Council of the European Thoracic Oncology Platform (ETOP), and appointed Member of the Board of Directors of the International Association for the Study of Lung Cancer (IASLC) for the 2017-2021 term. Enriqueta was Co-Chair of the IALSC’s 20thWorld Conference on Lung Cancer (WCLC) Congress, 07-10 September 2019, Barcelona (Spain). She currently serves as President of the Oncology Commission at Vall d’Hebron University Hospital and is also a Member of the Scientific Advisory Committee of the Parc Taulí Sabadell Hospital in Barcelona.
Most recently, in October 2019, Enriqueta was elected as President-Elect of the Sociedad Española de Oncología Médica – SEOM (the Spanish Society of Medical Oncology).
She is a Member of the Spanish Lung Cancer Group, SEOM, and the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), and the International Association for the Study of Lung Cancer (IASLC). She is author of numerous peer-reviewed articles and book chapters in the lung cancer field.
VHIO’s Thoracic Tumors & Head and Neck Cancer Group is dedicated to advancing cancer treatment and care for patients suffering from thoracic malignancies, including lung cancer, mesothelioma and thymic malignancies, and head and neck cancers. We focus on disease prevention, early detection and the more precise diagnosis and staging of disease toward improving clinical outcomes.
Our group strives to match currently available targeted therapies with specific molecular alterations identified in patients, unmask molecular mechanisms of acquired resistance, and optimize novel immunotherapy strategies.
For our patients with early-stage thoracic malignancies, we collaborate closely with a multidisciplinary team incorporating thoracic surgeons, radiation therapists, radiologists, pulmonologists, pathologists, and biologists. In so doing, we are potentiating several treatment approaches and modalities. Given that our patients can suffer from severe symptoms we are also deeply committed to ameliorating clinical outcomes by working in close connectivity with professionals across other disciplines.
Precision medicine for the treatment advanced lung cancer is no longer an ambition. It is a guiding principle. We establish molecular determinants of disease in individual tumors and circulating-free DNA (cfDNA) by liquid biopsy, to more effectively tailor therapies to the specificities of each patient’s individual disease.
For patients with head and neck tumors we work alongside expert surgeons, radiotherapists, radiologists, pathologists, and nutritionists, and also lead a clinical trial program to assess novel immunotherapeutics and targeted agents in this particular setting.
Immune-based strategies have a role in the treatment algorithm for the management of non-small cell lung cancer; a number of protocols are now ongoing at our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch. We contribute to VHIO’s early clinical drug development efforts, led by Elena Garralda, and also manage other less common thoracic malignancies including head and neck cancer, small-cell lung cancer, mesothelioma, thymoma and neuroendocrine tumors.
|Code||Clinical Trial Title||Phase|
|1336-0011||An open label phase Ib dose finding study of BI 836880 in
combination with BI 754091 to characterize safety, tolerability,
pharmacokinetics, pharmaco dynamics and efficacy in patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer and in other solid tumors.
|1613-LCG (APPLE)||APPLE trial: Feasibility and activity of AZD9291 (osimertinib) treatment on Positive PLasma T790M in EGFR mutant NSCLC patients.||II|
|1740-HNCG||RANDOMIZED PHASE II STUDY OF CISPLATIN PLUS RADIOTHERAPY VERSUS DURVALUMAB PLUS RADIOTHERAPY FOLLOWED BY ADJUVANT DURVALUMAB VERSUS DURVALUMAB PLUS RADI OTHERAPY FOLLOWED BY ADJUVANT TREMELIMUMAB AND DURVALUMAB IN INTERMEDIATE RISK HPV-POSITIVE LOCOREGIONALLY ADVANCED OROPHARYNGEAL SQUAMOUS CELL CANCER (LA-OSCC).||II|
|205801 (ENTREE LUNG)||A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants.||II|
|207675||A phase I, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3368715 in participants with solid tumors and DLBCL.||I|
|208471||A Phase 1b/2a Pilot Randomized Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T-Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794 ) Alone, or in Combination with Pembrolizumab in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer.||I|
|2SMALL||Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients with Advanced Small Cell Lung Cancer that Progressed Following Prior Therapy with P latinum-Based Chemotherapy.||I|
|40KA98 UVEA||Use Via Expanded Access to Brigatinib.||IV|
|61186372EDI1001||A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects with Advanced Non-Small Cell Lung Cancer.||I|
|63723283LUC1001||A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Su bjects with Advanced Cancers.||I|
|64619178EDI1001||A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subj ects with Advanced Cancers.||I|
|73841937NSC2001||A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced No n-Small Cell Lung Cancer (NSCLC).||I|
|ABI-007-NSCL-006||A PHASE 2, RANDOMIZED, OPEN-LABEL,MULTICENTER STUDY TO ASSESS SAFETY AND EFFICACY OF NAB®-PACLITAXEL (ABI-007) WITH EPIGENETIC MODIFYING THERAPY OF CC-486, AND NA B®-PACLITAXEL MONOTHERAPY AS SECOND-LINE TREATMENT IN SUBJECTS WITH ADVANCED NONSQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC): ABOUND.2L.||II|
|AP26113-13-301||A Phase 3 Multicenter Open-label Study of Brigatinib(AP26113)
versus Crizotinib in Patients with ALK-positive
Advanced Lung Cancer.
|AP32788-15-101||A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer.||II|
|APX005M-002||A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination with Nivolumab in Subjects with Non-small Cell Lung Cancer and Subjects with Metastatic Melanoma.||II|
|ARRAY-818-202||A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with BRAFV600E-mutant Non-small Cell Lung Cancer.||II|
|ASP-1929-301||A Phase 3, Randomized, Double-Arm, Open-Label, Controlled
Trial of ASP-1929 Photoimmunotherapy Versus Physician’s
Choice Standard of Care for the Treatment of Locoregional, Recurre nt Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be
|B7461001||PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATI ONS.||I|
|B7461001-II||PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATI ONS.||II|
|B7461006||“A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADV ANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER”||III|
|B9991005||A PHASE 1B/2, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WI TH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER.||I|
|BAY88-8223/19781||An open-label, multicenter, Phase 1/2 study of radium-223 dichloride in combination with pembrolizumab in participants with stage IV non-small cell lung cancer.||I|
|BGBC008||A Phase II Multi Center Study of BGB324 in Combination with
Pembrolizumab in Patients with Previously Treated Advanced Adenocarcinoma of
the LungA Phase II Multi Center Study of BG B324 in
Combination with Pembrolizumab in Patients with
Previously Treated Advanced Adenocarcinoma of the Lung.
|BO29554 (BFAST)||A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND
SAFETY OF MULTIPLE TARGETED
THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON−S MALL CELL LUNG
CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (BFAST: BLOOD FIRST
ASSAY SCREENING TRIAL).
|BO39610||A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (MORPHEUS-LUNG).||I|
|BO39633||AN OPEN-LABEL, MULTICENTER EXTENSION AND LONG-TERM OBSERVATIONAL STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH- AND/OR F. HOFFMANN-LA ROCHE LTD-SPONS ORED. TEZOLIZUMAB STUDY||IV|
|BO40336 (ALINA)||A PHASE III, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE
EFFICACY AND SAFETY OF
ADJUVANT ALECTINIB VERSUS ADJUVANT PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WIT H COMPLETELY RESECTED STAGE IB (TUMORS ³ 4 CM) TO STAGE IIIA ANAPLASTIC LYMPHOMA INASE-POSITIVE
NON-SMALL CELL LUNG CANCER.
|BP40234||AN OPEN-LABEL, MULTICENTER, PHASE II STUDY TO EVALUATE THE THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE, CONSISTING OF INTERLEUKIN-2 VARIANT (IL-2V) TARGET ING FIBROBLAST ACTIVATION PROTEIN-Α (FAP), IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1), ADMINISTERED INTRAVENOUSLY, IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.||I|
|BP40657||A RANDOMIZED, MULTICENTER, PHASE Ib/III STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS COMPARED WITH ATEZOLIZUM AB INTRAVENOUS IN ATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER||III|
|BP40657||A RANDOMIZED, MULTICENTER, PHASE Ib/III STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS COMPARED WITH ATEZOLIZUM AB INTRAVENOUS IN PATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER.||I|
|Brigatinib-1001||A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors.||I|
|Brigatinib-3001||A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIGTM) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non–Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib XALKORI®).||III|
|CA001044||A Phase 1/2 Randomized Trial of BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer||I|
|CA011-001||A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination with Nivolumab in Subjects with Selected Advanced Solid Tumors or Hematologic Mallignancies.||I|
|CA209-026||Ensayo fase 3, abierto y aleatorizado, de nivolumab frente a la quimioterapia de elección del investigador como tratamiento de primera línea del cáncer de pulmón no microcítico (CPNM) P D-L1+ en estadio IV o recidivante||III|
|CA209-057||Ensayo fase 3, aleatorizado, abierto, de BMS-936558 (nivolumab) frente a docetaxel en el cáncer de pulmón no microcítico (CPNM) metastásico no epidermoide tratado previamente||III|
|CA209-171||Ensayo clínico abierto y multicéntrico de nivolumab (BMS-936558) en monoterapia en sujetos con cáncer de pulmón no microcítico (CPNM) epidermoide avanzado o metastásico que han re cibido al menos dos líneas de tratamiento sistémico previas para el tratamiento del CPNM epidermoide en estadio IIIb/IV||II|
|CA209-227||Ensayo fase III, abierto, aleatorizado, de nivolumab o nivolumab más ipilimumab, frente a quimioterapia basada en doblete de platino en sujetos con cáncer de pulmón no microcítico (CPN M) en estadio IV o recidivante, que no han recibido quimioterapia previamente.||III|
|CA209-331||Estudio Fase 3 abierto, aleatorizado, de nivolumab o quimioterapia en sujetos con cáncer microcítico de pulmón en recaída después de quimioterapia de primera línea basada en platino||III|
|CA209-451||A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive- Stage Di sease Small Cell Lung Cancer (ED-SCLC) after Completion of Platinum-based First Line Chemotherapy.||III|
|CA209-651||An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as Firs t Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).||III|
|CA209-722||“Open-Label, Randomized Trial of Nivolumab (BMS-936558) plus Pemetrexed/Platinum or Nivolumab plus Ipilimumab (BMS-734016) vs Pemetrexed plus Platinum in Stage IV or Recurrent N on-Small Cell Lung Cancer (NSCLC) Subjects with Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed||III|
|CA209-816||Randomized, Open-Label Phase 3 Trial of Nivolumab and Ipilimumab versus Platinum-Doublet Chemotherapy in Early Stage NSCLC||III|
|CA209-817||A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Advanced malignancies||III|
|CA2099LA||A Phase 3, Randomized Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC).||III|
|CA223-001||"A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors"||I|
|CACZ885U2301 (CANOPY-1)||A randomized, double-blind, placebo-controlled, phase III
study evaluating the efficacy and safety of pembrolizumab
plus platinum-based doublet chemotherapy with or without canakinum ab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1).
|CC-90010-ST-001||A PHASE 1, OPEN-LABEL, DOSE-FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-90010 IN SUBJECTS WITH ADVANCED SOLID TUMORS AND RELAPSED/REFRACTORY NON-HODGKIN?S LYMPHOMAS||I|
|CC-90011-SCLC-001||A PHASE 1B, MULTICENTER, OPEN-LABEL, DOSE FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PRELIMINARY EFFICACY OF CC-90011 GIVEN IN COMBINATION WITH CISPLATIN AND ETOPOSIDE TO SUBJECTS WITH FIRST LINE, EXTENSIVE STAGE SMALL CELL LUNG CANCER.||I|
|CEGF816X2101-II||A phase I/II, multicenter, open-label study of
EGFRmut–TKI EGF816 administered orally in adult patients with
|CEGF816X2201C||Estudio de fase II, multicéntrico, abierto de EGF816 en combinación con nivolumab en pacientes adultos con cáncer de pulmón de células no pequeñas con mutación del EGFR y de INC280 e n combinación con nivolumab en pacientes adultos con cáncer de pulmón de células no pequeñas con cMet positivo.||II|
|CIDH305X2101||A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.||I|
|CINC280A2201||Estudio de fase II, multicéntrico, de tres cohortes con el inhibidor oral de cMET, INC280, en pacientes adultos con cáncer de pulmón de células no pequeñas (NSCLC) avanzado y EGFR wild ty pe (wt), que han recibido una o dos líneas previas de terapia sistémica para enfermedad avanzada/metastásico.||II|
|CINC280X2105C||A phase Ib/II, multicenter, open-label study of EGF816 in
combination with INC280 in adult patients with EGFR
mutated non-small cell lung cancer
|CINC280X2105C-II||A phase Ib/II, multicenter, open-label study of EGF816 in
combination with INC280 in adult patients with EGFR
mutated non-small cell lung cancer
|CL03-ORY-1001 SCLC (CLEPSIDRA)||A pilot study to assess the safety, tolerability, dose finding and efficacy ORY-1001 in combination with platinum-etoposide chemotherapy in patients with relapsed, extensive-stage disease s mall cell lung cancer.||II|
|CLDK378A2120C||A multi-center, open-label study to assess the safety and efficacy of combination ceritinib (LDK378) and nivolumab in adult patients with anaplastic lymphoma kinase (ALK)-positive non-sm all cell lung cancer (NSCLC)||I|
|CLDK378A2301||Estudio de fase III, multicéntrico, aleatorizado de LDK378 oral frente a quimioterapia estándar en pacientes adultos con cáncer de pulmón de células no pequeñas no escamoso con reordena miento de ALK (ALK-positivo) estadio IIIB o IV, que no han sido tratados previamente.||III|
|CLDK378A2X01B||Estudio de extensión de fase IV, multicéntrico, abierto en pacientes con tumores malignos ALK positivo que hayan finalizado un estudio previo de ceritinib (LDK378) patrocinado por Novarti s y que vayan a beneficiarse del tratamiento continuado con ceritinib según el criterio del investigador.||IV|
|CLXH254X2102||A Phase Ib, open-label, multicenter study of oral LXH254-
centric combinations in adult patients with advanced or
metastatic KRAS or BRAF mutant Non-Small Cell Lung Cancer or NRAS mut ant melanoma.
|CPDR001C2101||Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1unselected, metastatic NSCLC patients||I|
|CTNO155B12101||A Phase Ib, open-label, multi-center study to characterize the
safety, tolerability, and preliminary efficacy of TNO155
in combination with spartalizumab or ribociclib in selected malignancie s.
|CTNO155X2101||An open-label, multi-center, phase I, dose finding study of oral TNO155 in adult patients with advanced solid tumors||I|
|CV-8102-008||Phase I study of intratumoral CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.||I|
|D4191C00004 (ARTIC)||A Phase III, Open-label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) who Have Received at Least Two Prior Systemic reatment Regimens Including One Platinum-based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)||III|
|D5161C00003 (ELIOS)||"A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib".||II|
|D5164C00001(ADAURA)||A Phase I/II Multi-centre Study of AZD8931 in Combination with Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumours and in a Selected Population with Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer (THYME)||III|
|D5660C00004||A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumour Activity of MEDI4736 in Combination With AZD9150 or AZD5 069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.||II|
|D7980C00001 (MEDI5752)||A Phase 1, Open-label, Dose-escalation and Dose-expansion
Study to Evaluate the Safety, Tolerability Pharmacokinetics
Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects wit h Advanced Solid Tumors.
|D9108C00001 (COAST)||A Phase 2, Open-label, Multicenter, Randomized, Multidrug
Platform Study of Durvalumab Alone or in Combination with
Novel Agents in Subjects with Locally Advanced, Unresectable, Stag e III Non-small Cell Lung Cancer (COAST).
|D933QC00001(ADRIATIC)||A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Stage I-III Limited Disease Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC).||III|
|DIV-SCLC-301||"A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer"||II|
|DIV-SCLC-301-III||A Two-Part, Open-Label, Randomized, Phase II/III Study of
Dinutuximab and Irinotecan versus Irinotecan for Second Line
Treatment of Subjects with Relapsed or Refractory Small Cell Lung C ancer
|DS8201-A-U204||A PHASE 2, MULTICENTER, OPEN-LABEL, 2-COHORT STUDY OF
TRASTUZUMAB DERUXTECAN (DS-8201A),
AN ANTI-HER2 ANTIBODY DRUG CONJUGATE (ADC),FOR HER2-OVER-EXPRESSING O R -MUTATED,
UNRESECTABLE AND/OR METASTATIC NON-SMALLCELL LUNG CANCER (NSCLC).
|EMR100070-005||Ensayo de fase III, abierto y multicéntrico de avelumab (MSB0010718C) frente al doblete con base de platino como tratamiento de primera línea del cáncer de pulmón no microcítico PD-L1+ recurrente o en estadio IV||III|
|EMR200647-001 (TRAP001)||Ensayo de fase I, abierto, con dosis múltiples ascendentes, para investigar la seguridad, tolerabilidad, farmacocinética, y actividad biológica y clínica de MSB0011359C en sujetos con tumore s sólidos metastásicos o localmente avanzados y expansión a indicaciones seleccionadas||I|
|EORTC-1525-LCG||Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym).||II|
|ETOP 13-18 (BEAT-meso)||Ensayo clínico Fase III multicéntrico aleatorizado que compara atezolizumab más bevacizumab y la quimioterapia habitual con bevacizumab y la quimioterapia habitual como tratamiento de primera línea para el mesotelioma pleural maligno||III|
|ETOP 6-14 NICOLAS||A feasibility trial evaluating anti-PD1 nivolumab consolidation after standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B NSCLC||II|
|ETOP12-17 (ALERT-lung )||A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC.||II|
|GCT1021-01||First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax®-AXL-ADC) in patients with solid tumors.||I|
|GECP 17/02 (REPLAY)||A Phase II open-label multicenter exploratory study to assess efficacy of Pembrolizumab re-challange as second or further line in patients with advanced non - small cell lung cancer.||II|
|GECP 18/02 (NADIM II)||A randomized phase II study of neo-adjuvant chemo/immunotherapy versus chemotherapy alone for the treatment of locally advanced and potentially resectable nonsmall cell lung cancer ( NSCLC) patients” NADIM II.||II|
|GECP16-03 (NADIM)||Ensayo clínico fase II, exploratorio y multicéntrico, de quimioinmunoterapia neo-adyuvante para el tratamiento del cáncer de pulmón no microcítico estadío III operable||II|
|GECP17/04 (THOMAS)||An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer with HRAS mutations.||II|
|GECP17/05 (ML40238)||Phase II non-randomized study of atezolizumab (mpdl3280a) in combination with carboplatin plus pemetrexed in patients who are chemotherapy-naïve and have stage IV non-squamous no n-small cell lung cancer with asymptomatic brain metastasis.||II|
|GL0817-01||"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (with Cyclophosphamide) for the Prevention of Recurrence in HLA-A 2+ Patients with High-Risk Squamous Cell Carcinoma of the Oral Cavity"||II|
|GO29436||ESTUDIO FASE III, ABIERTO, ALEATORIZADO, DE MPDL3280A (ANTICUERPO ANTI-PD-L1) EN COMBINACIÓN CON CARBOPLATINO + PACLITAXEL CON O SIN BEVACIZUMAB COMPARADO CON CARBOPLATINO + PACLITAXEL + BEVACIZUMAB EN PACIENTES CON CÁNCER DE PULMÓN NO EPIDERMOIDE NO MICROCÍTICO EN ESTADIO IV QUE NO HAN RECIBIDO QUIMIOTERAPIA PREVIA||III|
|GO29527||A PHASE III, OPEN-LABEL, RANDOMIZED STUDY TO INVESTIGATE THE
EFFICACY AND SAFETY OF
ATEZOLIZUMAB (ANTI−PD-L1 ANTIBODY) COMPARED WITH BEST SUPPORTIVE CARE FOLLOWI NG ADJUVANT CISPLATIN-BASED CHEMOTHERAPY IN PD-L1−SELECTED PATIENTS WITH COMPLETELY RESECTED STAGE IB−IIIA NON−SMALL CELL LUNG CANCER.
|GO30081||ESTUDIO FASE III, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE CARBOPLATINO MÁS ETOPÓSIDO CON O SIN ATEZOLIZUMAB (ANTICUERPO ANTI-PD-L1) EN PACIENTES C ON CÁNCER DE PULMÓN MICROCÍTICO EN ETAPA AVANZADA NO TRATADO||III|
|GO40241||A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY
EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB
OR PLACEBO IN COMBIN ATION WITH PLATINUM-BASED
CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON−SMALL CELL LUNG CANCER.
|GO40290||A PHASE II, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF MTIG7192A, AN ANTI-TIGIT ANTIBODY, IN COMBINATION WITH ATEZOLIZUMAB IN CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER.||II|
|GO41767||A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY
OF ATEZOLIZUMAB PLUS
CARBOPLATIN AND ETOPOSIDE WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBOD Y) IN PATIENTS WITH
UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER
|HM-EMSI-202||Estudio de Fase 2, de un solo grupo y abierto, de evaluación de la eficacia, la seguridad y la farmacocinética de HM61713 en pacientes con cáncer de pulmón no microcítico (CPNM) con la m utación T790M tras el tratamiento con un inhibidor de a tirosina cinasa del receptor del factor de crecimiento epidérmico (EGFR-TKI)||II|
|I4T-MC-JVCY||Estudio multicéntrico, aleatorizado y doble ciego, en el que se evalúa erlotinib en combinación con ramucirumab o placebo en pacientes con cáncer de pulmón no microcítico metastásico y mutaciones activadoras de EGFR, previamente sin tratar||III|
|IO102-012(KN-764)||An Open-label, Randomized, Phase I/II Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as First-line Treatment for Pa tients with Metastatic Non-Small Cell Lung Cancer.||I|
|IRX-2 2015A||"A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy with the IRX 2 Regimen in Patients with Newly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity"||II|
|ISA101b-HN-01-17||A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Plati n-Resistant Oropharyngeal Cancer (OPC).||II|
|KO-TIP-001||An Open Label Phase II Study of Tipifarnib in Advanced NonHematological Malignancies with HRAS Mutations||I|
|KO-TIP-007||The AIM-HN and SEQ-HN Study: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRA S Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN).||II|
|LINC BR.31||Ensayo Clínico Fase III, prospectivo, aleatorizado, doble ciego, de quimioterapia adyuvante con MEDI4736 versus placebo en pacientes con cáncer de pulmón no microcítico con resección co mpleta||III|
|M14-239 (LUMINOSITY)||Estudio de fase II abierto para evaluar la seguridad y la eficacia de telisotuzumab vedotina (ABBV-399) en pacientes con cáncer de pulmón no microcítico c-Met+ tratado previamente.||II|
|M19-037||A Phase 1, Multi-Center, Open Label, Dose-Escalation Study to Determine the Safety, Tolerability and Pharmacokinetics of ABBV-927 and ABBV-368 with and without ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumor.||I|
|MK-7902-010||A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pemb rolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).||III|
|ML40221||REAL WORLD CLINICAL PRACTICE STUDY TO EVALUATE 2ND LINE
TREATMENT DECISION MAKING AS PER STANDARD OF CARE AND BASED ON FOUNDATION
MEDICINE® IN PATIENTS WITH L OCALLY ADVANCED
METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY IN SPAINREAL WORLD CLINICAL PRACTICE STUDY TO EVALUATE 2ND LINE TREATMENT DECISION MAKING AS PER STANDARD OF CARE AND BASED ON FOUNDATION MEDICINE® IN PATIENTS WITH LOCALLY ADVANCED OR
METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY IN SPAIN.
|MS200095-0022||Ensayo de fase II de un único grupo para investigar tepotinib en el adenocarcinoma pulmonar en estadio IIIB/IV con alteraciones por omisión del exón 14 de MET (METex14) tras fallar, como mínimo, un tratamiento activo anterior, incluido uno con doblete de platino.||II|
|MS200095-0031(INSIGHT-31)||A Phase II single-arm study to investigate tepotinib combined
with osimertinib in MET amplified, advanced or metastatic non-small cell lung
cancer (NSCLC) harboring activating EGFR mutati ons
and having acquired resistance to prior 1st to 3rd
generation EGFR-tyrosine kinase inhibitor therapy.
|MS200647-0005||A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Dur valumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer.||III|
|MS200647-0037||A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 versus Pembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lun g Cancer.||II|
|MS201944-0170||A Phase IIa, single-arm, multicenter study to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with advanc ed squamous non-small-cell lung cancer.||II|
|MYL-14020-3001||"Multicenter, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer"||II|
|ONCOS C719 (MESOS)||A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS-102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma.||II|
|OSE2101C301 (ATALANTE 1)||"A randomized parallel group phase III trial of OSE 2101 as 2nd line after prior platinum-based chemotherapy failure or as 3rd line after platinum-failure and checkpoint inhibitor-failure, co mpared with standard treatment (docetaxel or pemetrexed) in HLA-A2 positive patients with locally advanced (IIIB) unsuitable for radiotherapy or metastatic Non-Small-Cell Lung Cancer"||III|
|PM1183-C-003-14 (ATLANTIS)||Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin (DOX) versus Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR) (CAV) or Topotecan as Treatmen t in Patients with Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinumcontaining Line (ATLANTIS Trial).||III|
|R2810-ONC-1423 (REGENERON)||A First-in-Human Study of Repeat Dosing with REGN2810, a
Monoclonal, Fully Human Antibody to Programmed Death – 1
(PD-1), as Single Therapy and in Combination with Other Anti-Canc er Therapies, in Patients with Advanced Malignancies
|SGNTV-001||Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors.||I|
|SYM015-01||Ensayo de fase 1a/2a, abierto y multicéntrico, para investigar la seguridad, tolerabilidad y actividad antitumoral de dosis repetidas de Sym015, una mezcla de anticuerpos monoclonales diri gida frente al receptor MET, en pacientes con tumores malignos sólidos en fase avanzada||I|
|TACTI-002 (P015)||TACTI-002 (Two ACTive Immunotherapeutics): A multicenter, open label, Phase II study in patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC), or recurrent PD-X refractory NSCLC or with recurrent or metastatic squamous head and neck cancer (HNSCC) receiving the soluble LAG-3 fusion protein eftilagimod alpha (IMP321) in combination with pembrolizumab (PD-1 antagonist).||II|
|TAK-788-3001||A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non–Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations.||III|
|TPX-0005-01(TRIDENT-1)||A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harb oring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1).||II|
|U31402-A-U102||A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF U3-1402 IN SUBJECTS
WITH METASTATIC OR
UNRESECTABLE NON-SMALL CELL LUNG CANCER.
|VHIO17002 (MO39164)||Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours.||I|
|WIN001 (SPRING)||Survival Prolongation by Rationale INnovative Genomics (SPRING): A proof of concept study to explore safety and efficacy of tri-therapy approach in advanced/metastatic NSCLC and retrosp ectively assess the ability of integrated genomics and transcriptomics to match patients to the combination.||I|
|XL184-021 (PULMON)||A Phase 1b Dose Escalation Study of Cabozantinib (XL184) Administered in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors.||I|
|D910FC00001 (WAVE)||An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE).||IV|
|B9991040 (JAVELIN IL-2 Medley)||Phase 1b/2 clinical trial in patients locally recurrent (not amenable to curative intent) or metastatic SCCHN or metastatic castration-resistant prostate cancer (mCRPC),||I|
|16-214-05||A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combination with Pembrolizumab in Patients with Locally Advanced or Metasta tic Solid Tumors.||II|
|MK-1454-002||A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination with IV Pembrolizumab vs IV Pembrolizumab Monotherapy.||II|
|GO41717||A PHASE III, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED
STUDY OF TIRAGOLUMAB, AN ANTI-TIGIT ANTIBODY, IN COMBINATION WITH
ATEZOLIZUMAB COMPARED WITH PLAC EBO IN
WITH ATEZOLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PD-L1-SELECTED NON-SMALL CELL LUNG CANCER.
|209229 (INDUCE 3)||A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic He ad and Neck Squamous Cell Carcinoma .||II|
|CC-90011-ST-002||A Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with advanced cancers.||I|
|MK-7339-012||A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with
Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without
Olaparib vs Concurrent Chemoradiatio n Therapy
Followed by Durvalumab in Participants with
Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC).
|1438-0001||A First–in-human Phase I, non-randomized, open-label, multicenter dose escalation trial of BI 764532 administered by repeated intravenous infusions in patients with Small Cell Lung Carcin oma and other neuroendocrine neoplasms expressing DLL3.||I|
|M19-611||A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Canc er.||I|
|4020-01-001 (AMBER)||A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER).||I|
|1381.2||An open label, Phase I dose-finding study of BI 754111 in
combination with BI 754091 in patients with advanced solid
cancers followed by expansion cohorts at the selected dose of the com bination in patients with non-small cell lung cancer and other solid tumors.
|MK-7902-009||A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standar d of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009).||II|
|B7461027||Single-Arm Study of Lorlatinib in Participants with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Gener ation ALK Tyrosine Kinase Inhibitor (TKI).||IV|
|GO41836||A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH ATEZOLIZUMAB VERSUS ATEZOLIZUMAB ALONE FOLLO WING ADJUVANT PLATINUM-DOUBLET CHEMOTHERAPY IN PATIENTS WHO ARE ctDNA POSITIVE AFTER SURGICAL RESECTION OF STAGE II-III NON-SMALL CELL LUNG CANCER.||II|
|GECP 19/01 (CUBIK)||CLINICAL UTILITY OF LIQUID BIOPSY AS A TOOL TO ASSESS THE EVOLUTION OF BRIGATINIB TREATED PATIENTS WITH NON-SMALL CELL LUNG CANCER WITH EML4-ALK TRANSLOCATION: AN EXPLORATORY STUDY||II|
|MK-3475-671||A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II, III A, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC).||III|
|CINC280I12201||A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for lo cally advanced or metastatic non-small cell lung cancer with PD-L1≥ 50%.||II|
|BLU-667-2303 (AcceleRET)||A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non- Small Cell Lung Cancer.||III|
|D4194C00009 (DUART)||A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible fo r Chemotherapy (DUART).||II|
|GO41892 (CONTACT 01)||A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS DOCETAXEL MONOTHERAPY IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER PREVIOUSLY TREATED WITH AN ANTI-PD-L1/PD-1 ANTIBODY AND PLATINUM-CONTAINING CHEMOTHERAPY.||III|
|73841937NSC1001||An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-6118 6372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer.||I|
|CINC280J12201||A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatini b and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer patients with MET exon 14 skipping mutations.||II|
|D910LC00001 (MERMAID-1)||A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Com pletely Resected Stage II-III NSCLC (MeRmaiD-1).||III|
|20190009||A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Meta static NSCLC Subjects With Mutated KRAS p.G12C.||III|
|MK-7339-013||A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC).||III|
|SGNB6A-001||A Phase 1 Study of SGN-B6A in Advanced Solid Tumors.||I|
|HR-BLTN-III-NSCLC||A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib versus Docetaxel in Patients with Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation who Progressed on or after Treatment with Platinum Based Chemotherapy.||III|
|73841937NSC3003||A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Adva nced or Metastatic Non-Small Cell Lung Cancer(MARIPOSA).||III|
|209227 (INDUCE 4)||A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination with Pembrolizumab and 5FU-Platinum Chemotherapy versus Placebo in Combination with Pembro lizumab plus 5FU-Platinum Chemotherapy or First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.||III|
|1367.1||An open label, Phase Ia/Ib dose finding study with BI 894999 orally administered once a day in patients with advanced malignancies, with repeated administration in patients with clinical b enefit.||I|
|ETOP 15-19 ABC-lung||A randomised non-comparative open label phase II trial of atezolizumab plus bevacizumab, with carboplatin-paclitaxel or pemetrexed, in EGFR-mutant non-small cell lung carcinoma with ac quired resistance.||II|
|MK-7902-008||A Phase 3, multicenter, randomized, open-label trial to compare the efficacy and safety of pembrolizumab (MK-3475) in combination with lenvatinib (E7080/MK-7902) versus docetaxel in pr eviously treated participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and immunotherapy (anti-PD-1/PD-L1 inhibitor) (LEAP-008).||III|
|MK-3475-867||A Phase 3, Randomized, Placebo-Controlled Clinical Study to
Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT)
with or without Pembrolizumab (MK-3475) in Particip ants
with Medically Inoperable Stages I or IIA Non
Small Cell Lung Cancer (NSCLC) (KEYNOTE-867).
|MM-398-01-03-04-III (RESILIENT)||RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy.||III|
|MK-3475-669(INCB024360-304)||A Phase 3 Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of Pembrolizumab plus Epacadostat versus the EXTREME Regimen as First line Treatment for Recurrent or M etastatic Head and Neck Squamous Cell arcinoma (KEYNOTE- 669/ECHO-304).||III|
|MK-3475-598||A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimumab vs Pembrolizumab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Sub jects Whose Tumors are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598) .||III|
|MK-3475-495||A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475,SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; Ke yImPaCT).||II|
|MK-3475-689 (SCH 9000475)||A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable L ocoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC).||III|
|MK-3475-587||A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pe mbrolizumab Trial.||IV|
|MK-3475-789||A Randomized, Double-Blind, Phase 3 Study of Pemetrexed +
Platinum Chemotherapy with or without Pembrolizumab (MK-3475) in
TKI-resistant EGFR-mutated Tumors in Metastatic Non-s quamous Non-small Cell Lung Cancer (NSCLC) participants
|MK-3475-799||Ensayo de fase 2 de pembrolizumab (MK-3475) en combinación con quimioterapia con doblete de platino y radioterapia para participantes con cáncer de pulmón no microcítico (CPNM) en e stadio III irresecable y localmente avanzado (KEYNOTE-799).||II|
|BRIGATINIB-2002||Brigatinib en pacientes con cáncer de pulmón de células no pequeñas avanzado con linfoma anaplásico cinásico positivo (ALK+) cuyo cáncer ha progresado durante el tratamiento con alecti nib o ceritinib.||II|
|MK-3475-782||A Phase II Trial to Investigate Genetic Markers of Response to Pembrolizumab (MK-3475, SCH 900475) Combined with Chemotherapy as a First-line Treatment for Non-Small Cell Lung Cance r (KEYNOTE-782).||II|
|MK-3475-412||A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412).||III|
|MK-3475-604||A Phase III Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475) in combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the first-line treatment o f Subjects with Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)||III|
|MK-3475-189||A Randomized, Double-Blind, Phase III Study of Platinum+ Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).||III|
|MK-3475-091 (PEARLS)||Ensayo de fase III, aleatorizado, con el anticuerpo monoclonal anti-PD-1 pembrolizumab (MK-3475) en comparación con placebo en pacientes con CPNM en estadios iniciales tras la resecció n y la finalización del tratamiento adyuvante de referencia (PEARLS)||III|
|MK-3475-407||A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)||III|
|MK-3475-048||Ensayo Clínico Fase 3 de Pembrolizumab (MK-3475) en Primera Línea de Tratamiento para Carcinoma Recurrente/Metastásico de Células Escamosas de Cabeza y Cuello||III|
|MK-3475-024||Ensayo de fase III, abierto y aleatorizado de MK-3475 en comparación con quimioterapia basada en el platino en sujetos tratados en primera línea con cáncer de pulmón no microcítico meta stásico con expresión intensa de PD-L1||III|
|MK-3475-010||A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer.||II|