RecruitingPhase 2NCT05733598

Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC

A Phase 2, Open-label, Multicenter Study Investigating RP2 Oncolytic Immunotherapy in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable, Recurrent and/or Metastatic Hepatocellular Carcinoma


Sponsor

Replimune, Inc.

Enrollment

60 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an oncolytic virus therapy called RP2 (a specially engineered herpes virus that attacks tumour cells) combined with second-line cancer treatments in two groups: people with liver cancer (HCC) that progressed after immunotherapy, and people with advanced bile duct/gallbladder cancer (BTC) who are currently on standard first-line treatment. RP2 is injected directly into tumours to trigger an immune response against the cancer. **You may be eligible if...** - You are 18 or older - (For liver cancer): You have advanced liver cancer that progressed while on a first-line immunotherapy-containing regimen - (For bile duct/gallbladder cancer): You have advanced disease currently on first-line chemotherapy plus immunotherapy for at least 12 weeks - You have at least one tumour that can be directly injected - Your liver function, blood counts, and organ function meet minimum thresholds - You are in good overall health (ECOG 0 or 1) **You may NOT be eligible if...** - You have active herpes infections, or a history of serious herpes complications - You have untreated variceal bleeding or liver disease that is too advanced (Child-Pugh B or C) - You have HIV, active tuberculosis, or serious uncontrolled infection - You have had a prior oncolytic virus therapy - You are pregnant or breastfeeding - You have a serious autoimmune disease requiring systemic treatment - You have had a recent heart attack or severe heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRP2

Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

BIOLOGICALBevacizumab

Anti-VEGF therapy.

BIOLOGICALAtezolizumab

Anti-PD-L1 monoclonal antibody.

BIOLOGICALDurvalumab

Anti-PD-L1 monoclonal antibody

BIOLOGICALRP2 Monotherapy

Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.


Locations(12)

Beverly Hills Cancer Center

Beverly Hills, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics)

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Montefiore Medical CenterMontefiore Medical Park

The Bronx, New York, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

The West Clinic

Germantown, Tennessee, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Houston Methodist Hospital Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05733598


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