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

NCT04549025 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: JTX-4014-202
• Study Type: interventional
• Target: 69
• Locations: 14 countries
• Sites: 72

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Change in measurable lesion size

  Mean percent change from baseline tumor size of all measurable existing and new lesions

  over 9 and 18 weeks (average)

Secondary Outcomes (16)

• Overall response rate (ORR)

  up to 24 months

• Progression-free survival (PFS)

  up to 24 months

• Landmark PFS rate

  9 months

• Disease control rate (DCR)

  up to 24 months

• Duration of response (DOR)

  up to 24 months

Study Arms (3)

Monotherapy Cohort 1 (MC1)

EXPERIMENTAL

Enrolled patients will receive 1000 mg pimivalimab (JTX-4014) administered alone every 6 weeks (q6w).

Drug: Pimivalimab

Combination Therapy Cohort 1 (CC1)

EXPERIMENTAL

For Cycle 1, enrolled patients will receive 0.1 mg/kg vopratelimab (JTX-2011) on Day 1, followed by 1000 mg pimivalimab (JTX-4014) on Day 8. For Cycle 2 and beyond, vopratelimab and pimivalimab will be administered in combination (on Day 1) q6w.

Drug: Pimivalimab; Drug: Vopratelimab

Combination Therapy Cohort 2 (CC2)

EXPERIMENTAL

For Cycle 1, enrolled patients will receive 0.03 mg/kg vopratelimab (JTX-2011) on Day 1, followed by 1000 mg pimivalimab (JTX-4014) on Day 8. For Cycle 2 and beyond, vopratelimab and pimivalimab will be administered in combination (on Day 1) q6w.

Drug: Pimivalimab; Drug: Vopratelimab

Interventions

Pimivalimab DRUG

Specified dose on specified days

Also known as: JTX-4014

Combination Therapy Cohort 1 (CC1); Combination Therapy Cohort 2 (CC2); Monotherapy Cohort 1 (MC1)

Vopratelimab DRUG

Specified dose on specified days

Also known as: JTX-2011

Combination Therapy Cohort 1 (CC1); Combination Therapy Cohort 2 (CC2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures;
• Histologically or cytologically confirmed diagnosis of NSCLC with evaluable or measurable disease according to RECIST v1.1 with at least 1 measurable lesion;
• Confirmed tumor RNA signature score in accordance with the study protocol;
• Previously treated for locally advanced or metastatic NSCLC with 1 prior systemic antineoplastic platinum-containing regimen. Regimen should consist of chemotherapy or with bevacizumab;
• Age of ≥18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Predicted life expectancy of ≥ 3months;
• Specified laboratory values in accordance with the study protocol;
• If with medical history of the following, eligibility should be discussed with the Medical Monitor:
• Prior biliary tract disorders (based on Medical Dictionary for Regulatory Activities \[MedDRA\] system organ class of Hepatobiliary disorders and MedDRA high-level terms of Obstructive bile duct disorders, Hepatic vascular disorders, and Structural and other bile duct disorders);
• Portal hypertension and/or hepatic vascular disorders;
• For women of childbearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned Cycle 1, Day 1 (C1D1) and a negative urine or serum pregnancy test on C1D1. In addition, the WOCBP must be willing to complete a urine or serum pregnancy test prior to each dose of either study drug;
• WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration. Highly effective methods of birth control are defined as those that, alone or in combination, result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.

You may not qualify if:

• Concurrent anticancer treatment or subject is expected to require any other form of antineoplastic therapy while on study, either approved or investigational;
• Current or past participation in a study of an investigational agent or using an investigational device in the metastatic setting;
• Chemotherapy \<28 days prior to planned C1D1
• Prior immunotherapy including, but not limited to PD-1 or PD-L1 inhibitor monoclonal antibody (mAb) at any time, including pimivalimab; therapy with any mAb that specifically binds to ICOS, including vopratelimab; or chimeric antigen receptor T cell therapy;
• Organ transplantation, including allogenic or autologous stem cell transplantation;
• Use of anticancer therapies listed below in the metastatic setting (allowed as prior treatment for localized disease):
• Biologic therapy
• Targeted therapy, with the exception of bevacizumab if administered in combination with a platinum-based chemotherapy regimen as first line treatment
• Positive test for any of the following epidermal growth factor receptor gene mutations in blood or tumor: Exon 18 G719A; Exon 18 G719C; Exon 18 G719S; Exon 19 Del; Exon 20 S768I; Exon 20 T790M; Exon 20 Ins; Exon 21 L858R; Exon 21 L861Q;
• The following toxicity history:
• Ongoing toxicity attributed to prior therapy that was Grade \>1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); Exceptions: Grade \>1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement therapy) and are approved by the Medical Monitor;
• History of pneumonitis or interstitial lung disease;
• Symptomatic ascites or pleural effusion (subjects who are clinically stable for \>3 months following treatment for these conditions \[including therapeutic thoraco- or paracentesis\] are eligible);
• If with medical history of the following, eligibility should be discussed with the Medical Monitor: colitis, hepatitis, nephritis, skin reactions, or encephalitis;
• Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV Ig preparations; any history of anaphylaxis; prior history of human anti-human antibody response; or known allergy to any of the study drugs (including their analogues or excipients \[L-Histidine, mannitol, sodium chloride, or polysorbate 80\]);

Sponsors & Collaborators

• Jounce Therapeutics, Inc.: lead

Study Sites (72)

Minsk City Clinical Oncology Dispensary

Minsk, Belarus

Location

N. N. Alexandrov National Cancer Centre

Minsk, Belarus

Location

University Clinical Center of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo

Sarajevo, Bosnia and Herzegovina

Location

Multiprofile Hospital for Active Treatment - Dobrich AD

Dobrich, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Uni Hospital OOD

Panagyurishte, Bulgaria

Location

Complex Oncology Center Plovdiv

Plovdiv, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, Bulgaria

Location

Clinical Hospital Centre Osijek

Osijek, Croatia

Location

General Hospital Pula

Pula, Croatia

Location

University Hospital of Split

Split, Croatia

Location

Klinicki bolnicki centar Zagreb

Zagreb, Croatia

Location

Arensia Tbilisi - PPDS

Tbilisi, Georgia

Location

Veszprem Megyei Tudogyogyintezet

Farkasgyepű, Hungary

Location

Bács-Kiskun Varmegyei Oktatokorhaz

Kecskemét, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Riga East Clinical University Hospital, Latvian Oncology Center

Riga, Latvia

Location

Arensia Chisinau - PPDS

Chisinau, Moldova

Location

Affidea Romania SRL

Bucharest, Romania

Location

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

Constanța, Romania

Location

Oncology Center Sfantul Nectarie

Craiova, Romania

Location

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Russia

Location

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', Russia

Location

Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

Krasnoyarsk, Russia

Location

Kursk Regional Oncology Centre

Kursk, Russia

Location

Vitamed Multidisciplinary Medical Center

Moscow, Russia

Location

Nizhniy Novgorod City Oncology Center

Nizhny Novgorod, Russia

Location

Clinical Oncology Dispensary

Omsk, Russia

Location

PMI Euromedservice

Pushkin, Russia

Location

Ryazan State Medical University n.a. I.P. Pavlov

Ryazan, Russia

Location

First St. Petersburg State Medical University n.a. I.P Pavlov

Saint Petersburg, Russia

Location

GBUZ St. Petersburg Clinical Research Center of Specialized Types of Care Oncology n.a. Napalkova

Saint Petersburg, Russia

Location

JSC "Current medical technologies"

Saint Petersburg, Russia

Location

Mordovia State University

Saransk, Russia

Location

Research Oncology Institute of Tomsk Scientific Center

Tomsk, Russia

Location

Volgograd Regional Clinical Oncology Dispensary

Volgograd, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, Russia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

Location

Institute for Oncology and Radiology of Serbia - PPDS

Belgrade, Serbia

Location

University Clinical Center of Serbia - PPDS

Belgrade, Serbia

Location

Institute of Lung Diseases Vojvodina

Kamenitz, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, Serbia

Location

Narodny onkologicky - PPDS

Bratislava, Slovakia

Location

Vychodoslovensky onkologicky ustav, a.s.

Košice, Slovakia

Location

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty Hospital

Ankara, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty Hospital

Antalya, Turkey (Türkiye)

Location

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane - Hematoloji Bilim Dali

Edirne, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

Location

T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye)

Location

Izmir Ekonomi University Medical Point Hospital

Izmir, Turkey (Türkiye)

Location

Inonu University Faculty of Medicine Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

Location

Communal Nonprofit Enterprise Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of ChOC

Cherkasy, Ukraine

Location

Communal Nonprofit Enterprise City Clinical Hospital #4 of Dnipro City Council

Dnipro, Ukraine

Location

Municipal Nonprofit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC

Ivano-Frankivsk, Ukraine

Location

Arensia Kapitanivka - PPDS

Kapitanivka, Ukraine

Location

Communal Nonprofit Enterprise Regional Center of Oncology

Kharkiv, Ukraine

Location

SI Institute of Medical Radiology and Oncology n.a. S.P. Hryhoriev of NAMS of Ukraine

Kharkiv, Ukraine

Location

Communal Nonprofit Enterprise Khmelnytskyi Regional Antitumor Center of Khmelnytskyi Regional Council

Khmelnytskyi, Ukraine

Location

Private Enterprise Private Manufacturing Company Acinus

Kropyvnytskyi, Ukraine

Location

Clinic of National Institute of Cancer

Kyiv, Ukraine

Location

Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center

Kyiv, Ukraine

Location

Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

Kyiv, Ukraine

Location

Medical Center of LLC ARENSIA Exploratory Medicine

Kyiv, Ukraine

Location

ME Volyn Regional Clinical Hospital of the Volyn Regional Council Regional Medical Oncology Centre

Lutsk, Ukraine

Location

Medical and diagnostic center of MediX-Ray International Group LLC Israeli Oncology Hospital LISOD

Obukhiv, Ukraine

Location

MNPE Central City Clinical Hospital of Uzhhorod City Council

Uzhhorod, Ukraine

Location

Study Officials

• Stew Kroll

  Jounce Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 16, 2020
• Study Start: October 19, 2020
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

HU (3); SL (2); CR (4); LA (2); MO (1); RO (4); TU (9); UA (15); BU (5); BE (2); BO (2); GE (1); RU (17); SE (5)