Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors

May 28, 2024 updated by: Jounce Therapeutics, Inc.

An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas - MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health Systems

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:

  • 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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Vopratelimab
Specified dose on specified days
Other Names:
  • JTX-2011
Experimental: Vopratelimab with nivolumab
Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: Vopratelimab
Specified dose on specified days
Other Names:
  • JTX-2011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Adverse Events (AEs)
Time Frame: Approximately 34 months
Percentage of subjects with at least one AE
Approximately 34 months
Percentage of Subjects With Serious Adverse Events (SAEs)
Time Frame: Approximately 34 months
Percentage of subjects with at least one SAE
Approximately 34 months
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
Time Frame: Approximately 34 months
Percentage of subjects with at least one clinically significant change from baseline in clinical laboratory tests (i.e., change requiring adjustment of dose, clinical intervention or administration of concomitant medication)
Approximately 34 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Progression Free Survival (mPFS)
Time Frame: Approximately 34 months
mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)
Approximately 34 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)

March 10, 2020

Primary Completion (Actual)

January 3, 2023

Study Completion (Actual)

January 3, 2023

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JTX-2011-R01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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