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 (SELECT)

March 8, 2024 updated by: Jounce Therapeutics, Inc.

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

This is a Phase 2, open-label study to evaluate PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and 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 JTX-4014 alone and in combination with vopratelimab 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

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
        • Minsk City Clinical Oncology Dispensary
      • Minsk, Belarus
        • N. N. Alexandrov National Cancer Centre
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • Klinicki centar Republike Srpske
      • Sarajevo, Bosnia and Herzegovina
        • Klinicki centar Univerziteta u Sarajevu
  • Bulgaria
      • Dobrich, Bulgaria
        • Multiprofile Hospital for Active Treatment - Dobrich AD
      • Panagyurishte, Bulgaria
        • Multiprofile Hospital for Active Treatment - Uni Hospital OOD
      • Plovdiv, Bulgaria
        • Complex Oncology Center Plovdiv
      • Sofia, Bulgaria
        • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
      • Sofia, Bulgaria
        • Multiprofile Hospital for Active Treatment Serdika EOOD
  • Croatia
      • Osijek, Croatia
        • Klinicki bolnicki centar Osijek
      • Pula, Croatia
        • General Hospital Pula
      • Split, Croatia
        • Klinicki Bolnicki Centar Split
      • Zagreb, Croatia
        • Klinicki bolnicki centar Zagreb
  • Georgia
      • Tbilisi, Georgia
        • ARENSIA Exploratory Medicine LLC / Tbilisi, Georgia
  • Hungary
      • Farkasgyepű, Hungary
        • Veszprem Megyei Tudogyogyintezet
      • Kecskemét, Hungary
        • Bács-Kiskun Megyei Kórház, SZTE ÁOK Oktató Kórháza
      • Székesfehérvár, Hungary
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia
        • Riga East Clinical University Hospital, Latvian Oncology Center
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Institute of Oncology, ARENSIA Exploratory Medicine
  • Romania
      • Bucharest, Romania
        • Affidea Romania SRL
      • Cluj-Napoca, Romania
        • Prof Dr I Chiricuta Institute of Oncology
      • Constanţa, Romania
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
      • Craiova, Romania
        • Oncology Center Sfantul Nectarie
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Arkhangelsk Regional Clinical Oncology Dispensary
      • Chelyabinsk, Russian Federation
        • Chelyabinsk Regional Clinical Oncology Dispensary
      • Kazan, Russian Federation
        • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
      • Krasnoyarsk, Russian Federation
        • Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
      • Kursk, Russian Federation
        • Kursk Regional Oncology Centre
      • Moscow, Russian Federation
        • Vitamed
      • Nizhny Novgorod, Russian Federation
        • Nizhniy Novgorod City Oncology Center
      • Omsk, Russian Federation
        • Clinical Oncology Dispensary
      • Pushkin, Russian Federation
        • Evromedservis LCC
      • Ryazan', Russian Federation
        • Ryazan State Medical University n.a. I.P. Pavlov
      • Saint Petersburg, Russian Federation
        • First St. Petersburg State Medical University n.a. I.P Pavlov
      • Saint Petersburg, Russian Federation
        • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
      • Saint Petersburg, Russian Federation
        • JSC "Current medical technologies"
      • Saransk, Russian Federation
        • Mordovia State University
      • Tomsk, Russian Federation
        • Research Oncology Institute of Tomsk Scientific Center
      • Volgograd, Russian Federation
        • Volgograd regional clinical oncology dispensary
      • Yaroslavl, Russian Federation
        • Regional Clinical Oncology Hospital
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia - PPDS
      • Belgrade, Serbia
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia
        • Institute for Oncology and Radiology of Serbia - PPDS
      • Kragujevac, Serbia
        • Clinical Center Kragujevac
      • Sremska Kamenica, Serbia
        • Institute of Lung Diseases Vojvodina
  • Slovakia
      • Bratislava, Slovakia
        • Narodny Onkologicky Ustav
      • Košice, Slovakia
        • Vychodoslovensky onkologicky ustav, a.s.
  • Turkey
      • Adana, Turkey
        • Adana Sehir Egitim ve Arastirma Hastanesi
      • Antalya, Turkey
        • Akdeniz University Medical Faculty
      • Edirne, Turkey
        • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey
        • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
      • Malatya, Turkey
        • Inonu University Faculty of Medicine Turgut Ozal Medical Center
      • İzmir, Turkey
        • Ege Universitesi Tip Fakultesi Hastanesi
      • İzmir, Turkey
        • Izmir Medicalpark Hospital
    • Sihhiye
      • Ankara, Sihhiye, Turkey, 06100
        • Hacettepe University Medical Faculty Hospital
  • Ukraine
      • Cherkasy, Ukraine
        • Communal Nonprofit Enterprise Cherkasy Regional Onсology Dispensary of Cherkasy Oblast Council
      • Dnipro, Ukraine
        • Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS
      • Ivano-Frankivs'k, Ukraine
        • Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC"
      • Kapitanivka, Ukraine
        • Arensia Kapitanivka - PPDS
      • Kharkiv, Ukraine
        • Communal Non-profit Enterprise Regional Center of Oncology
      • Kharkiv, Ukraine
        • SI Institute of Medical Radiology and Oncology n.a. S.P. Hryhoriev of NAMS of Ukraine
      • Khmelnytskyi, Ukraine
        • CNPE Khmelnytskyi Regional Antitumor Center of Khmelnytskyi Regional Council
      • Kropyvnytskyi, Ukraine
        • Private Enterprise Private Manufacturing Company Acinus
      • Kyiv, Ukraine
        • 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
        • Modern Cancer Care Hospital "LISOD"
      • Luts'k, Ukraine
        • The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
      • Uzhhorod, Ukraine
        • MNPE Central City Clinical Hospital of Uzhhorod City Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able and willing to participate and comply with all study requirements
  • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with evaluable or measurable disease according to RECIST v1.1 with at least 1 measurable lesion
  • Confirmed tumor RNA signature score
  • Experienced progression of locally advanced or metastatic NSCLC after 1 prior systemic antineoplastic platinum-containing regimen (adjuvant therapy will count as a regimen if administered within 1 year before the relapse)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Predicted life expectancy of ≥ 3 months
  • Adequate organ function
  • WOCBP must agree to use highly effective birth control

Exclusion Criteria:

  • 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 mAb at any time, including JTX-4014; therapy with any mAb that specifically binds to ICOS, including vopratelimab; or chimeric antigen receptor T cell therapy

  • Use of anticancer therapies listed below in the metastatic setting (allowed as prior treatment for localized disease):

    1. Biologic therapy
    2. Targeted small molecule therapy
    3. Organ transplantation, including allogeneic or autologous stem cell transplantation
  • 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
  • Prior whole brain radiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JTX-4104
Drug: JTX-4014
Drug: JTX-4014
Specified dose on specified days
Experimental: JTX 4014 in combination with vopratelimab (dose level 1)

Drug: JTX-4014

Drug: Vopratelimab Other Name: JTX-2011
Drug: Vopratelimab
Specified dose on specified days
Other Names:
  • JTX-2011
Drug: JTX-4014
Specified dose on specified days
Experimental: JTX 4014 in combination with vopratelimab (dose level 2)

Drug: JTX-4014

Drug: Vopratelimab Other Name: JTX-2011
Drug: Vopratelimab
Specified dose on specified days
Other Names:
  • JTX-2011
Drug: JTX-4014
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in measurable lesion size
Time Frame: averaged over 9 and 18 weeks
Mean percent change from baseline in all measurable lesions
averaged over 9 and 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 24 months
ORR according to RECIST v1.1
up to 24 months
PFS
Time Frame: up to 24 months
PFS according to RECIST v1.1
up to 24 months
Landmark progression free survival (PFS)
Time Frame: 9months
Landmark progression free survival (PFS)
9months
Disease control rate (DCR)
Time Frame: up to 24 months
Disease control rate (DCR) according to RECIST v1.1
up to 24 months
Median duration of response (DOR)
Time Frame: up to 24 months
Median duration of response (DOR) according to RECIST v1.1
up to 24 months
Median overall survival (OS)
Time Frame: up to 24 months
Median overall survival (OS)
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jounce Therapeutics, Inc.

Investigators

  • Study Director: Stew Kroll, Jounce Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JTX-4014-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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