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

NCT ID: NCT04319224

Last Updated: 2024-05-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2023-01-03

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vopratelimab

Participants will continue to receive vopratelimab monotherapy per parent protocol.

Group Type EXPERIMENTAL

Vopratelimab

Intervention Type DRUG

Specified dose on specified days

Vopratelimab with ipilimumab

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

Group Type EXPERIMENTAL

Vopratelimab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Vopratelimab with nivolumab

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

Group Type EXPERIMENTAL

Vopratelimab

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Vopratelimab

Specified dose on specified days

Intervention Type DRUG

Ipilimumab

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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JTX-2011 Yervoy Opdivo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jounce Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stew Kroll

Role: STUDY_DIRECTOR

Jounce Therapeutics, Inc.

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Virginia Health Systems

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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JTX-2011-R01

Identifier Type: -

Identifier Source: org_study_id

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