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Trial Title:
Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)
NCT ID:
NCT05572970
Condition:
Cancer
Conditions: Keywords:
Balstilimab
AGEN2034
Zalifrelimab
AGEN1884
Monotherapy
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
Balstilimab
Description:
An anti-programmed death 1 (PD-1) monoclonal antibody.
Other name:
AGEN2034
Intervention type:
Drug
Intervention name:
Zalifrelimab
Description:
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Other name:
AGEN1884
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants must have completed predicate study protocol requirements, including
prior treatment duration and follow-up.
Exclusion Criteria:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Lead sponsor:
Agency:
Agenus Inc.
Agency class:
Industry
Source:
Agenus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05572970
