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Vopratelimab (JTX-2011) Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors

Sponsor
Jounce Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04319224
Collaborator
(none)
20
Enrollment
2
Locations
3
Arms
52.7
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

JTX-2011-R01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

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 an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study
Actual Study Start Date :
Mar 10, 2020
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vopratelimab

Participants will continue to receive vopratelimab monotherapy per parent protocol.

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

    		•
    Experimental: Vopratelimab with ipilimumab

    Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.

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

    • Drug: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy

    		•
    Experimental: Vopratelimab with nivolumab

    Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.

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

    • Drug: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. % subjects with adverse events (AEs) [48 months]

    2. % subjects with serious adverse events (SAEs) [48 months]

    3. % subjects with clinically significant change from baseline in clinical laboratory tests [48 months]

    Secondary Outcome Measures

    1. Median progression free survival (PFS) [48 months]

    Eligibility Criteria

    Criteria

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

    • Subject is currently receiving and tolerating vopratelimab (JTX-2011) therapy and receiving clinical benefit from study treatment in the opinion of the Investigator and/or Sponsor.

    • Subject has demonstrated compliance with the parent study requirements, as assessed by the Investigator and/or Sponsor, and is able and willing to comply with the necessary visits and assessments as part of the rollover study.

    • Written informed consent must be obtained prior to enrolling in the rollover study and receiving study treatment. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

    • Women of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment

    Exclusion Criteria:

    • Subject was permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.

    • Subject is receiving concurrent anti-cancer treatment (excluding combination drugs such as nivolumab or ipilimumab as a component of the combination dosing regimen used in parent study).

    • Women who are pregnant or breastfeeding.

    • Subject has any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110
    2 The University of Texas - MD Anderson Cancer Center Houston Texas United States 77030

    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:
    NCT04319224
    Other Study ID Numbers:
    • JTX-2011-R01
    First Posted:
    Mar 24, 2020
    Last Update Posted:
    Mar 12, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jounce Therapeutics, Inc.
    JTX-2011
    Vopratelimab
    Ipilimumab
    Nivolumab
    ICOS
    Anti-CTLA-4
    PD-1
    PD-L1
    Immunotherapy
    Immuno-oncology
    Cancer
    Additional relevant MeSH terms:
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Mar 12, 2021