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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Replimune, Inc.
Study ID
NCT05733598
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RP2 — BIOLOGICAL
    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
  • Bevacizumab — BIOLOGICAL
    Anti-VEGF therapy.
  • Atezolizumab — BIOLOGICAL
    Anti-PD-L1 monoclonal antibody.
  • Durvalumab — BIOLOGICAL
    Anti-PD-L1 monoclonal antibody
  • RP2 Monotherapy — BIOLOGICAL
    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2026
Primary completion
Dec 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RP2+Bevacizumab and Atezolizumab
    HCC Cohort 1a and 1b: Patients with locally advanced unresectable, recurrent and/or metastatic HCC who have progressed on 1 prior systemic treatment, which must have included anti-programmed cell death 1 (PD-1)/anti-PD-L1 therapy. Patients will receive atezolizumab plus bevacizumab therapy combined with RP2. In cohort 1a, patients will receive RP2 intratumorally every 2 weeks (Q2W) for 4 doses, then every 3 weeks (Q3W) for 4 doses combined with atezolizumab plus bevacizumab. In cohort 1b, patients will receive RP2 intratumorally every 2 weeks (Q2W) for 8 doses combined with atezolizumab plus bevacizumab.
  • Experimental: RP2 Monotherapy
    HCC Cohort 2: Patients with locally advanced unresectable, recurrent and/or metastatic HCC who have progressed on 1 prior systemic treatment, which must have included anti-programmed cell death 1 (PD-1)/anti-PD-L1 therapy. Patients will receive RP2 monotherapy every 2 weeks (Q2W).
  • Experimental: RP2+Durvalumab
    BTC Cohort (Cohort 3): Patients with locally advanced or metastatic BTC (intrahepatic or extrahepatic cholangiocarcinoma or gall bladder carcinoma), who have received treatment with combination gemcitabine, platinum-containing chemotherapy, and checkpoint inhibitor for a minimum of 12 weeks (4 to 8 cycles) and maximum of 24 weeks, and who have had stable disease or partial response on 2 on treatment scans and no progressive disease. After the last combination chemotherapy treatment, checkpoint inhibitor treatment must be limited to 2 doses (8 weeks). Patients will receive durvalumab combined with RP2.

Primary Outcome Measure

Overall Response Rate per modified RECIST 1.1 [ Time Frame: From Day 1 up to 3 years after first RP2 dose of last patient. ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer CenterBeverly HillsCalifornia90211
Afshin Eli Gabayan, MD
UC San Diego Moores Cancer CenterLa JollaCalifornia92037
Adam Burgoyne, MD
Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics)MiamiFlorida33136
Lynn Goy Feun, MD
Moffitt Cancer CenterTampaFlorida33612
Richard Kim, MD
University of Maryland Medical CenterBaltimoreMaryland21201
Kevin"Hyun" Kim, MD
Roswell Park Comprehensive Cancer CenterBuffaloNew York14236
Renuka Iyer, MD
Montefiore Medical CenterMontefiore Medical ParkThe BronxNew York10461
Yvonne Saenger,, MD
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104
William Chapin, MD
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Anwaar Saeed, MD.
The West ClinicGermantownTennessee38138
Axel Grothey, MD
University of Tennessee Medical CenterKnoxvilleTennessee37920
Saikrishna Gadde, MD
Houston Methodist Hospital Cancer CenterHoustonTexas77030
Maen Abdelrahim, MD

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Beverly Hills Cancer Center· Beverly Hills, CAUC San Diego Moores Cancer Center· La Jolla, CASylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics)· Miami, FLMoffitt Cancer Center· Tampa, FLUniversity of Maryland Medical Center· Baltimore, MDRoswell Park Comprehensive Cancer Center· Buffalo, NY

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