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NCT05733598 · ClinicalTrials.gov registry record · Phase 2
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC
A Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer, sponsored by Replimune.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 11
- Study locations
NCT05733598: Recruiting Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer, sponsored by Replimune.
NCT05733598 is a Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer that is actively recruiting participants, run by Replimune. The registered enrollment target is 60 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (77% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05733598, a Phase 2 study of Hepatocellular Carcinoma and Biliary Tract Cancer, is actively recruiting participants, sponsored by Replimune.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and/or metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC.
Primary Outcome
The proportion of patients achieving a BOR of CR or PR per RECIST 1.1 among those that are evaluable for response.
Conditions Studied
Interventions
- BIOLOGICAL Atezolizumab
- BIOLOGICAL Durvalumab
- BIOLOGICAL Bevacizumab
- BIOLOGICAL RP2
- BIOLOGICAL RP2 Monotherapy
Study Locations (11)
California
- Beverly Hills Cancer Center - Beverly Hills
- UC San Diego Moores Cancer Center - La Jolla
Florida
- Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics) - Miami
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Montefiore Medical CenterMontefiore Medical Park - The Bronx
Pennsylvania
- University of Pennsylvania, Abramson Cancer Center - Philadelphia
- UPMC Hillman Cancer Center - Pittsburgh
Tennessee
- The West Clinic - Germantown
- University of Tennessee Medical Center - Knoxville
Maryland
- University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
What NCT05733598 shows while recruiting
NCT05733598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT05733598 lists 11 locations in 6 states (California, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT05733598 about?
NCT05733598 is a clinical study titled "Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC". The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and/or metastatic HCC and in combinati...
What is the current status of trial NCT05733598?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-08-01. Estimated completion is 2028-07-01.
What conditions does trial NCT05733598 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Biliary Tract Cancer.
What interventions are being tested in trial NCT05733598?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), Durvalumab (BIOLOGICAL), Bevacizumab (BIOLOGICAL), RP2 (BIOLOGICAL), RP2 Monotherapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT05733598?
This trial is sponsored by Replimune, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05733598 being conducted?
This trial has 11 study locations across California, Florida, Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05733598's enrollment target sits among peer trials
60 77th of 145 higher than 67 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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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