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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

NSCLC

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Stew Kroll

Affiliation: Jounce Therapeutics, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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