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Brief Title: Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen
Official Title: Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen
Study ID: NCT04549025
Brief Summary: This is a Phase 2, open-label study to evaluate PD-1 inhibitor pimivalimab (JTX-4014) alone and in combination with vopratelimab (JTX-2011), an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen.
Detailed Description: Pimivalimab is a fully human IgG4 monoclonal antibody designed to specifically bind to programmed cell death receptor protein-1 (PD-1) and block its interaction with its ligands, programmed cell death receptor protein-1 ligand 1 (PD-L1) and programmed cell death receptor protein-1 ligand 2 (PD-L2), to augment anti-tumor T cell activity. Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 2, open label study to evaluate the efficacy, safety, tolerability of pimivalimab alone and in combination with vopratelimab in biomarker-selected adult subjects with metastatic non-small cell lung cancer (NSCLC) who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum-based chemotherapy regimen.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Minsk City Clinical Oncology Dispensary, Minsk, , Belarus
N. N. Alexandrov National Cancer Centre, Minsk, , Belarus
University Clinical Center of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Clinical Center University of Sarajevo, Sarajevo, , Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich, , Bulgaria
Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagyurishte, , Bulgaria
Complex Oncology Center Plovdiv, Plovdiv, , Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia, , Bulgaria
Clinical Hospital Centre Osijek, Osijek, , Croatia
General Hospital Pula, Pula, , Croatia
University Hospital of Split, Split, , Croatia
Klinicki bolnicki centar Zagreb, Zagreb, , Croatia
Arensia Tbilisi - PPDS, Tbilisi, , Georgia
Veszprem Megyei Tudogyogyintezet, Farkasgyepű, , Hungary
Bács-Kiskun Varmegyei Oktatokorhaz, Kecskemét, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár, , Hungary
Pauls Stradins Clinical University Hospital, Riga, , Latvia
Riga East Clinical University Hospital, Latvian Oncology Center, Riga, , Latvia
Arensia Chisinau - PPDS, Chisinau, , Moldova, Republic of
Affidea Romania SRL, Bucharest, , Romania
Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta, Constanţa, , Romania
Oncology Center Sfantul Nectarie, Craiova, , Romania
Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangel'sk, , Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, , Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan, , Russian Federation
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy, Krasnoyarsk, , Russian Federation
Kursk Regional Oncology Centre, Kursk, , Russian Federation
Vitamed Multidisciplinary Medical Center, Moscow, , Russian Federation
Nizhniy Novgorod City Oncology Center, Nizhny Novgorod, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
PMI Euromedservice, Pushkin, , Russian Federation
Ryazan State Medical University n.a. I.P. Pavlov, Ryazan', , Russian Federation
First St. Petersburg State Medical University n.a. I.P Pavlov, Saint Petersburg, , Russian Federation
GBUZ St. Petersburg Clinical Research Center of Specialized Types of Care Oncology n.a. Napalkova, Saint Petersburg, , Russian Federation
JSC "Current medical technologies", Saint Petersburg, , Russian Federation
Mordovia State University, Saransk, , Russian Federation
Research Oncology Institute of Tomsk Scientific Center, Tomsk, , Russian Federation
Volgograd Regional Clinical Oncology Dispensary, Volgograd, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Clinical Hospital Center Bezanijska Kosa, Belgrade, , Serbia
Institute for Oncology and Radiology of Serbia - PPDS, Belgrade, , Serbia
University Clinical Center of Serbia - PPDS, Belgrade, , Serbia
University Clinical Center Kragujevac, Kragujevac, , Serbia
Institute of Lung Diseases Vojvodina, Sremska Kamenica, , Serbia
Narodny onkologicky - PPDS, Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav, a.s., Košice, , Slovakia
Adana Sehir Egitim ve Arastirma Hastanesi, Adana, , Turkey
Hacettepe University Medical Faculty Hospital, Ankara, , Turkey
Akdeniz University Medical Faculty Hospital, Antalya, , Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane - Hematoloji Bilim Dali, Edirne, , Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital, Istanbul, , Turkey
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi, İzmir, , Turkey
Izmir Ekonomi University Medical Point Hospital, İzmir, , Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center, Malatya, , Turkey
Communal Nonprofit Enterprise Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of ChOC, Cherkasy, , Ukraine
Communal Nonprofit Enterprise City Clinical Hospital #4 of Dnipro City Council, Dnipro, , Ukraine
Municipal Nonprofit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC, Ivano-Frankivs'k, , Ukraine
Arensia Kapitanivka - PPDS, Kapitanivka, , Ukraine
Communal Nonprofit Enterprise Regional Center of Oncology, Kharkiv, , Ukraine
SI Institute of Medical Radiology and Oncology n.a. S.P. Hryhoriev of NAMS of Ukraine, Kharkiv, , Ukraine
Communal Nonprofit Enterprise Khmelnytskyi Regional Antitumor Center of Khmelnytskyi Regional Council, Khmelnytskyi, , Ukraine
Private Enterprise Private Manufacturing Company Acinus, Kropyvnytskyi, , Ukraine
Clinic of National Institute of Cancer, Kyiv, , Ukraine
Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center, Kyiv, , Ukraine
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway, Kyiv, , Ukraine
Medical Center of LLC ARENSIA Exploratory Medicine, Kyiv, , Ukraine
ME Volyn Regional Clinical Hospital of the Volyn Regional Council Regional Medical Oncology Centre, Luts'k, , Ukraine
Medical and diagnostic center of MediX-Ray International Group LLC Israeli Oncology Hospital LISOD, Obukhiv, , Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council, Uzhhorod, , Ukraine
Name: Stew Kroll
Affiliation: Jounce Therapeutics, Inc.
Role: STUDY_DIRECTOR