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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04319224
• Other study ID #: JTX-2011-R01
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 10, 2020
• Est. completion date: January 3, 2023

Study information

• Verified date: May 2024
• Source: Jounce Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Vopratelimab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	The University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Jounce Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Adverse Events (AEs)	Percentage of subjects with at least one AE	Approximately 34 months
Primary	Percentage of Subjects With Serious Adverse Events (SAEs)	Percentage of subjects with at least one SAE	Approximately 34 months
Primary	Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests	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	Median Progression Free Survival (mPFS)	mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)	Approximately 34 months