Clincosm LogoSign in Get a demo

SELECT: 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

Sponsor
Jounce Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04549025
Collaborator
(none)
75
Enrollment
68
Locations
3
Arms
28.4
Anticipated Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 19, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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: JTX-4014
Specified dose on specified days

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

    		•
    Experimental: JTX 4014 in combination with vopratelimab (dose level 2)

    Drug: JTX-4014 Drug: Vopratelimab Other Name: JTX-2011

    Drug: JTX-4014
    Specified dose on specified days

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in measurable lesion size [averaged over 9 and 18 weeks]

      Mean percent change from baseline in all measurable lesions

    Secondary Outcome Measures

    1. ORR [up to 24 months]

      ORR according to RECIST v1.1

    2. PFS [up to 24 months]

      PFS according to RECIST v1.1

    3. Landmark progression free survival (PFS) [9months]

      Landmark progression free survival (PFS)

    4. Disease control rate (DCR) [up to 24 months]

      Disease control rate (DCR) according to RECIST v1.1

    5. Median duration of response (DOR) [up to 24 months]

      Median duration of response (DOR) according to RECIST v1.1

    6. Median overall survival (OS) [up to 24 months]

      Median overall survival (OS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Minsk City Clinical Oncology Dispensary Minsk Belarus
    2 N. N. Alexandrov National Cancer Centre Minsk Belarus
    3 Klinicki centar Republike Srpske Banja Luka Bosnia and Herzegovina
    4 Klinicki centar Univerziteta u Sarajevu Sarajevo Bosnia and Herzegovina
    5 Multiprofile Hospital for Active Treatment - Dobrich AD Dobrich Bulgaria
    6 Multiprofile Hospital for Active Treatment - Uni Hospital OOD Panagyurishte Bulgaria
    7 Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda Sofia Bulgaria
    8 Multiprofile Hospital for Active Treatment Serdika EOOD Sofia Bulgaria
    9 Klinicki bolnicki centar Osijek Osijek Croatia
    10 General Hospital Pula Pula Croatia
    11 Klinicki bolnicki centar Split Split Croatia
    12 ARENSIA Exploratory Medicine LLC / Tbilisi, Georgia Tbilisi Georgia
    13 Veszprem Megyei Tudogyogyintezet Farkasgyepű Hungary
    14 Bács-Kiskun Megyei Kórház, SZTE ÁOK Oktató Kórháza Kecskemét Hungary
    15 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár Hungary
    16 Pauls Stradins Clinical University Hospital Riga Latvia
    17 Riga East Clinical University Hospital, Latvian Oncology Center Riga Latvia
    18 Institute of Oncology, ARENSIA Exploratory Medicine Chisinau Moldova, Republic of
    19 Prof Dr I Chiricuta Institute of Oncology Cluj-Napoca Romania
    20 Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta Constanţa Romania
    21 Oncology Center Sfantul Nectarie Craiova Romania
    22 Arkhangelsk Regional Clinical Oncology Dispensary Arkhangel'sk Russian Federation
    23 Chelyabinsk Regional Clinical Oncology Dispensary Chelyabinsk Russian Federation
    24 Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic Kazan Russian Federation
    25 Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy Krasnoyarsk Russian Federation
    26 Kursk Regional Oncology Centre Kursk Russian Federation
    27 Vitamed Moscow Russian Federation
    28 Nizhniy Novgorod City Oncology Center Nizhny Novgorod Russian Federation
    29 Clinical Oncology Dispensary Omsk Russian Federation
    30 Evromedservis LCC Pushkin Russian Federation
    31 Ryazan State Medical University n.a. I.P. Pavlov Ryazan' Russian Federation
    32 First St. Petersburg State Medical University n.a. I.P Pavlov Saint Petersburg Russian Federation
    33 GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) Saint Petersburg Russian Federation
    34 JSC "Current medical technologies" Saint Petersburg Russian Federation
    35 Mordovia State University Saransk Russian Federation
    36 Research Oncology Institute of Tomsk Scientific Center Tomsk Russian Federation
    37 Volgograd Regional Clinical Oncology Dispensary Volgograd Russian Federation
    38 Regional Clinical Oncology Hospital Yaroslavl Russian Federation
    39 Clinical Center of Serbia - PPDS Belgrade Serbia
    40 Clinical Hospital Center Bezanijska Kosa Belgrade Serbia
    41 Institute for Oncology and Radiology of Serbia - PPDS Belgrade Serbia
    42 Clinical Center Kragujevac Kragujevac Serbia
    43 Institute of Lung Diseases Vojvodina Sremska Kamenica Serbia
    44 Narodny onkologicky ustav Bratislava Slovakia
    45 Vychodoslovensky onkologicky ustav, a.s. Košice Slovakia
    46 Hacettepe University Medical Faculty Hospital Ankara Sihhiye Turkey 06100
    47 Adana Sehir Egitim ve Arastirma Hastanesi Adana Turkey
    48 Akdeniz University Medical Faculty Antalya Turkey
    49 Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane Edirne Turkey
    50 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey
    51 T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital Istanbul Turkey
    52 Ege Universitesi Tip Fakultesi Hastanesi İzmir Turkey
    53 Izmir Medicalpark Hospital İzmir Turkey
    54 Inonu University Faculty of Medicine Turgut Ozal Medical Center Malatya Turkey
    55 Communal Nonprofit Enterprise Cherkasy Regional Onсology Dispensary of Cherkasy Oblast Council Cherkasy Ukraine
    56 Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS Dnipro Ukraine
    57 Municipal Non-profit Enterprise "SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC" Ivano-Frankivs'k Ukraine
    58 Arensia Kapitanivka - PPDS Kapitanivka Ukraine
    59 Communal Non-profit Enterprise Regional Center of Oncology Kharkiv Ukraine
    60 SI Institute of Medical Radiology and Oncology n.a. S.P. Hryhoriev of NAMS of Ukraine Kharkiv Ukraine
    61 CNPE Khmelnytskyi Regional Antitumor Center of Khmelnytskyi Regional Council Khmelnytskyi Ukraine
    62 Private Enterprise Private Manufacturing Company Acinus Kropyvnytskyi Ukraine
    63 Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center Kyiv Ukraine
    64 Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway Kyiv Ukraine
    65 Modern Cancer Care Hospital "LISOD" Kyiv Ukraine
    66 National Institute of Cancer Kyiv Ukraine
    67 The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council Luts'k Ukraine
    68 MNPE Central City Clinical Hospital of Uzhhorod City Council Uzhhorod Ukraine

    Sponsors and Collaborators

    • Jounce Therapeutics, Inc.

    Investigators

    • Study Director: Ellen Hooper, MD, Jounce Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jounce Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04549025
    Other Study ID Numbers:
    • JTX-4014-202
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    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
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jun 23, 2022