Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)
Sponsor: Agenus Inc.
ClinicalTrials ID:NCT05572970
This expanded access study involves up to 100 participants previously treated with balstilimab and/or zalifrelimab, who have benefited and wish to continue. Participants are reevaluated annually for treatment benefit and eligibility. Eligibility requires completion of prior study protocols. Balstilimab is an anti-PD-1 antibody, and zalifrelimab is an anti-CTLA-4 antibody.
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Program Overview
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.
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.
Eligibility Criteria
Inclusion Criteria
- Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.
Exclusion Criteria
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