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HCC: Metastatic: 2nd Line: Non-cirrhotic: Oncolytic immunotherapy: RP2-003

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

Title
Replimune RP2-003 HCC
Study Title

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

Site Link
Malignancy
Hepatocellular carcinoma, HCC
Stage
Disease Setting
Metastatlic/palliative
Line Of Therapy
2nd Line
Investigational Agent
RP2, becacizumab, atezolizumab
Drug Class
Oncolytic immunotheerapy, Anti-VEGF, Anti-PD-L1
PI
Axel Grothey, MD
Sponsor
Replimune
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Locally advanced unresectable, recurrent, and/or metastatic HCC
  • Must have progressed on 1st line therapy that contained anti-PD-1 or anti-PD-L1 therapy as their immediate prior treatment regimen
  • Child-Pugh A determined withint 14 days of first treatment
  • All patients must undergo EGD with esophageal varices assessment
  • Measurable and injectable disease
  • Must be willing to undergo biopsy
  • ECOG PS 0-1
  • No significant bleeding event in last 12 months
  • No macroscopic vascular invastion into major blood vessels
  • No rare HCC variants
  • No liver tumors that are estimated to invade more than one-third of the liver
  • No known acute or chronic HBV/HCV unless PCR below lower limits of detection
  • No known HIV
  • No known CNS metastatses
Objective
  • Primary
    • ORR
  • Secondary
    • AEs
    • ORR per HCC modified RECIST
    • DoR
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Hepatocellular carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X