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

Phase 1

Terminated

• Conditions: Cancer
• Interventions: Drug: Vopratelimab; Drug: Nivolumab; Drug: Ipilimumab

• Registration Number: NCT04319224
• Lead Sponsor: Jounce Therapeutics, Inc.

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).

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 Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Results First Submitted: 2023-05-02
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Results First Posted: 2024-05-30
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vopratelimab with nivolumab	Nivolumab	Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
Vopratelimab with ipilimumab	Ipilimumab	Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.
Vopratelimab with ipilimumab	Vopratelimab	Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.
Vopratelimab	Vopratelimab	Participants will continue to receive vopratelimab monotherapy per parent protocol.
Vopratelimab with nivolumab	Vopratelimab	Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Adverse Events (AEs)	Approximately 34 months	Percentage of subjects with at least one AE
Percentage of Subjects With Serious Adverse Events (SAEs)	Approximately 34 months	Percentage of subjects with at least one SAE
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests	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)

Secondary Outcome Measures

Name	Time	Method
Median Progression Free Survival (mPFS)	Approximately 34 months	mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)

Trial Locations

Locations (3)

The University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Virginia Health Systems; 🇺🇸 Charlottesville, Virginia, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States