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
Replimune, Inc.
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.
Description
This is a Phase 2, open-label, multicenter study evaluating RP2 oncolytic immunotherapy in combination with atezolizumab plus bevacizumab and RP2 monotherapy 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 (Cohort 3). The study periods will consist of Screening, Treatment, and Follow-Up: * 28-day Screening Period * Treatment Period * HCC Cohorts (Cohort 1a, 1b, and 2): First tumor assessment at 10 weeks (± 3 days) from t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: I 1. Male or female ≥ 18 years of age. I 2. (HCC only) Has locally advanced unresectable, recurrent, and/or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features or imaging criteria (using LI-RADS v2018; \[Chernyak 2018\]) according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis (Marrero 2018). Sites should select lesions that are either "probable HCC - LIRADS 4" or "definite HCC - LIRADS 5". I 3. (HCC only) Must have progressed while on first and only systemic therapy, w…
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 CenterBeverly Hills, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics)Miami, Florida
- Moffitt Cancer CenterTampa, Florida
- University of Maryland Medical CenterBaltimore, Maryland
- Roswell Park Comprehensive Cancer CenterBuffalo, New York