Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)
- Conditions
- Cancer
- Registration Number
- NCT05572970
- Lead Sponsor
- Agenus Inc.
- Brief Summary
This is an expanded access study for cancer treatment with balstilimab alone or in combination with zalifrelimab for an intermediate-size participant population. This study addresses the treatment needs of participants who have been previously and specifically treated with balstilimab alone or in combination with zalifrelimab in a clinical study, who have experienced a benefit from this treatment and/or wish to continue treatment, and who are eligible for treatment under this expanded access study.
- Detailed Description
This study will not exceed 100 participants. Participants will be reevaluated annually to assess the treatment benefit of zalifrelimab and/or balstilimab and thereby, continued eligibility for treatment. Under this program, treatment will be continued with balstilimab, as either monotherapy or as used in combination therapy with zalifrelimab, for participants that have previously received one or both of these investigational medicinal products in a clinical study.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Hoag Gynecologic Oncology
🇺🇸Newport Beach, California, United States
University of California, San Francisco Medical Center
🇺🇸San Francisco, California, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Texas Oncology
🇺🇸Flower Mound, Texas, United States