RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
NCT03894215 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211
Last updated 2026-03-27
Summary
This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate.
Conditions
Interventions
- DRUG
-
AGEN2034
PD-1 antibody
- DRUG
-
AGEN1884
CTLA-4 antibody
Sponsors & Collaborators
-
GOG Foundation
collaborator NETWORK -
Agenus Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Agenus Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-01
- Primary Completion
- 2025-03-26
- Completion
- 2025-03-26
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Mexico
- Peru
- South Korea
- Taiwan
- Thailand
Study Locations
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