NCT05733598 · Replimune Inc.
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC
What this study is about
The purpose of this study is to assess the effectiveness and safety of RP2 in combination with atezolizumab plus bevacizumab in the second line setting for locally advanced unresectable, recurrent, and/or metastatic HCC group of participants and to assess the effectiveness and safety of RP2 in combination with durvalumab after chemotherapy is discontinued in the first line setting for unresectable locally advanced or metastatic BTC group of participants.
View original scientific description
The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab in the second line setting for locally advanced unresectable, recurrent, and/or metastatic HCC cohort and to assess the efficacy and safety of RP2 in combination with durvalumab after chemotherapy is discontinued in the first line setting for unresectable locally advanced or metastatic BTC cohort.
Interventions
BIOLOGICAL
RP2
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
BIOLOGICAL
Bevacizumab
Anti-VEGF therapy.
BIOLOGICAL
Atezolizumab
Anti-PD-L1 monoclonal antibody.
BIOLOGICAL
Durvalumab
Anti-PD-L1 monoclonal antibody
BIOLOGICAL
RP2 Monotherapy
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
Primary outcome measures
Overall Response Rate per modified RECIST 1.1
Time frame: From Day 1 up to 3 years after first RP2 dose of last patient.
The proportion of patients achieving a BOR of CR or PR per RECIST 1.1 among those that are evaluable for response.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, which must have included anti PD-1 or anti-PD-L1 therapy (eg, atezolizumab plus bevacizumab combination, durvalumab plus tremelimumab combination, durvalumab, pembrolizumab, or nivolumab monotherapy or nivolumab in combination with ipilimumab) as their immediate prior treatment regimen. I 4. (HCC only) Child-Pugh A, determined within 14 days before first study treatment. I 5. Has at least 1 measu
Where
- Beverly Hills, California
- La Jolla, California
- Miami, Florida
- Tampa, Florida
- Baltimore, Maryland
- Buffalo, New York
- The Bronx, New York
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Germantown, Tennessee
- Knoxville, Tennessee
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations