OncoMatch/Clinical Trials/NCT05733598
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC
Is NCT05733598 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for hepatocellular carcinoma.
Treatment: RP2 · Bevacizumab · Atezolizumab · Durvalumab · RP2 Monotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Cholangiocarcinoma
Disease stage
Required: Stage III, IV
Has at least 1 measurable tumor of ≥ 1 cm in longest diameter (or ≥ 1.5 cm shortest diameter for lymph nodes) as defined by RECIST 1.1.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy (atezolizumab, durvalumab, pembrolizumab, nivolumab) — first-line
(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.
Must have received: checkpoint inhibitor — concurrent with gemcitabine and platinum chemotherapy
(BTC only) Patients must be on combination treatment with gemcitabine, platinum containing chemotherapy, and a checkpoint inhibitor for a minimum of 12 weeks and maximum of 24 weeks. After the last combination chemotherapy treatment (gemcitabine plus platinum chemotherapy), checkpoint inhibitor treatment must be limited to 2 doses (8 weeks).
Cannot have received: oncolytic virus therapy
Received prior treatment with an oncolytic virus therapy.
Lab requirements
Blood counts
WBC ≥ 2.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L (without G-CSF); platelets ≥ 75 × 10^9/L (without transfusion); hemoglobin ≥ 8.5 g/dL (not transfusion-dependent)
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/minute
Liver function
total bilirubin ≤ 3.0 × ULN; AST, ALT, and ALP ≤ 5.0 × ULN; Child-Pugh A required for HCC
Has adequate hematologic function... Has adequate hepatic function... Has adequate renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beverly Hills Cancer Center · Beverly Hills, California
- UC San Diego Moores Cancer Center · La Jolla, California
- Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics) · Miami, Florida
- Moffitt Cancer Center · Tampa, Florida
- University of Maryland Medical Center · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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