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

• Status: Recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jounce Therapeutics, Inc.
• Treatments: Ipilimumab; Nivolumab

Criteria

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.