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NCT03894215 · ClinicalTrials.gov registry record · Phase 2
RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
A Phase 2 study of Cervical Cancer, sponsored by Agenus.
- Active
- Registry status
- Phase 2
- Development phase
- 212
- Enrollment target
- 20
- Study locations
NCT03894215: Active Phase 2 study of Cervical Cancer, sponsored by Agenus.
NCT03894215 is a Phase 2 study of Cervical Cancer that is active but no longer recruiting, run by Agenus. The registered enrollment target is 212 participants, below the 569-participant average among 144 other Cervical Cancer trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03894215, a Phase 2 study of Cervical Cancer, is active but no longer recruiting, sponsored by Agenus.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 212 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
To assess the Objective Response Rate (ORR) to the treatment of AGEN2034 (anti-PD-1) administered with placebo (Treatment Arm 1 - monotherapy), or with AGEN1884 (anti-CTLA4) (Treatment Arm 2 - combination therapy), defined as the binomial proportion of intent to treat (ITT) patients with best overall response (BOR) of complete response (CR) or partial response (PR), in women with recurrent/persistent/metastatic cervical cancer who have progressed following first-line therapy. BOR will be determi
Conditions Studied
Interventions
- DRUG AGEN2034
- DRUG AGEN1884
Study Locations (20)
California
- University of California, San Diego (UCSD) - Moores Cancer Center - La Jolla
- UCLA- Women's Health Clinical Research Unit (WHCRU) - Los Angeles
- Gynecologic Oncology Associates - Newport
- California Pacific Medical Center - San Francisco
- University of California, San Francisco Medical Center - San Francisco
Alabama
- University of Alabama at Birmingham School of Medicine - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Arizona Oncology - Biltmore Cancer Center - Phoenix
- Arizona Oncology - Tucson - Wilmot Road Location - Tucson
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
- Moffitt Cancer Center - Tampa
Georgia
- Northside Hospital - Atlanta
- St Joseph's Hospital - Savannah
New York
- Northwell Health Monter Cancer Center - Lake Success
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
Indiana
- Community Health Network - North Cancer Center - Indianapolis
Kentucky
- University of Kentucky Albert B. Chandler Hospital - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What the registry record for NCT03894215 still lists
NCT03894215 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 569-participant average among 144 other Cervical Cancer trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 2 interventions - of which AGEN2034 is the first listed.
NCT03894215 names 20 study sites across 11 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT03894215 about?
NCT03894215 is a clinical study titled "RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer". 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 r...
What is the current status of trial NCT03894215?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2019-06-01. Estimated completion is 2026-09.
What conditions does trial NCT03894215 study?
This clinical trial studies the following conditions: Cervical Cancer.
What interventions are being tested in trial NCT03894215?
The interventions under investigation include: AGEN2034 (DRUG), AGEN1884 (DRUG).
Who is sponsoring clinical trial NCT03894215?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03894215 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03894215's enrollment target sits among peer trials
212 46th of 144 higher than 99 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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