Actively Recruiting
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC
Led by Replimune, Inc. · Updated on 2026-04-02
60
Participants Needed
12
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- For HCC: locally advanced unresectable, recurrent, and/or metastatic hepatocellular carcinoma confirmed by biopsy, cytology, clinical features, or imaging
- For HCC: progressed after first systemic therapy including anti PD-1 or anti-PD-L1 treatment
- For HCC: Child-Pugh A liver function within 14 days before treatment
- At least one measurable tumor 1 cm or larger by RECIST 1.1
- Injectable tumors totaling at least 1 cm in diameter
- Willing to provide a fresh or archival tumor biopsy sample within 90 days before treatment
- Adequate blood function (WBC ≥ 2.0 x 10⁹/L; ANC ≥ 1.5 x 10⁹/L; platelets ≥ 75 x 10⁹/L; hemoglobin ≥ 8.5 g/dL)
- Adequate liver function (total bilirubin ≤ 3.0 x ULN; AST, ALT, ALP ≤ 5.0 x ULN)
- Adequate kidney function (serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min)
- Serum albumin ≥ 2.8 g/dL
- Prothrombin time ≤ 1.5 x ULN (or INR ≤ 1.7) and PTT/aPTT ≤ 1.5 x ULN
- ECOG performance status of 0 or 1
- Women of childbearing potential must have negative pregnancy tests and agree to effective contraception during and after treatment
- Men must agree to use contraception or abstain from intercourse during and after treatment
- Able to provide informed consent
- For BTC: histologically confirmed unresectable locally advanced or metastatic biliary tract cancer treated with gemcitabine, platinum chemotherapy, and checkpoint inhibitors for 12 to 24 weeks
You will not qualify if you...
- For HCC: Child-Pugh B or C liver function
- Untreated or incompletely treated esophageal or gastric varices with bleeding or high bleeding risk
- Recent significant bleeding events posing risk for tumor injection
- For HCC: major blood vessel invasion or rare HCC variants
- History of refractory hepatic encephalopathy or hepato-renal syndrome
- Disease suitable for curative surgery or local therapies
- Liver tumor invasion over one-third of the liver
- Uncontrolled pleural, pericardial effusion, or ascites requiring drainage within 7 days
- Hepatitis B virus DNA > 500 IU/mL or co-infection with hepatitis C virus
- Known HIV infection
- Active or complicated herpetic infections requiring systemic antivirals
- Serious infections requiring IV antibiotics within 14 days
- Live vaccine administration within 28 days before treatment
- Known CNS metastases or carcinomatous meningitis
- Active malignancy within 3 years except certain localized cancers
- Participation in another investigational study within 4 weeks
- Recent systemic anticancer therapy or radiotherapy with unresolved toxicities
- Prior treatment with oncolytic virus therapy
- Significant cardiac disease or recent myocardial infarction
- Uncontrolled infections requiring IV antibiotics
- History of severe lung diseases or active pneumonitis
- Active tuberculosis
- Psychiatric or substance abuse disorders that interfere with study participation
- Conditions or treatments that could affect study results or patient safety
- Active autoimmune diseases requiring systemic treatment
- Recent use of high-dose immunosuppressive corticosteroids
- Allergies or sensitivities to study treatment components
- History of severe immune therapy toxicity
- Recent use of anticoagulants or antiplatelet agents for therapeutic purposes
- Recent use of botanical or herbal treatments
- Prior organ transplantation
- Recent major surgery without adequate recovery
- For BTC: ampullary carcinoma, mixed cholangiocarcinoma with HCC, or mismatch repair deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
3
Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics)
Miami, Florida, United States, 33136
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
6
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14236
Actively Recruiting
7
Montefiore Medical CenterMontefiore Medical Park
The Bronx, New York, United States, 10461
Actively Recruiting
8
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
The West Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
11
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
12
Houston Methodist Hospital Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Clinical Trials at Replimune
CONTACT
C
Clinical Trials at Replimune
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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