RP3-003 – A Study Investigating RP3 Oncolytic Immunotherapy in Combination with First-or Second-line Therapy in Patients with Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Clinical Trials.gov: https://clinicaltrials.gov/show/NCT05733598

Identifier: NCT05733598

This is a Phase II study that will evaluate whether treatment with RP3 can provide additional efficacy as 1L treatment combined with Atezolizumab plus Bevacizumab in patients with locally advanced unresectable or metastatic HCC or provide efficacy as 2L treatment combined with atezolizumab plus bevacizumab in patients with recurrent or metastatic HCC.

Who is this study for?

This study is for patients with a diagnosis of advanced unresectable, recurrent, and/or metastatic hepatocellular carcinoma (HCC).

Key Elgibility Criteria

You may be eligible for this study if you meet the following conditions:

  • Are at least 18 years old.
  • Have had Child-Pugh A, determined within 14 days before first study treatment.
  • Have at least 1 measurable tumor of ≥1 cm in longest diameter (or ≥1.5 cm shortest diameter for lymph nodes).
  • Are capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form.
  • Have no Child-Pugh B or C.
  • Have no untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding.
  • Have no histologic evidence of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma with HCC, or other rare HCC variants.
  • Have no known acute or chronic hepatitis B or known acute or chronic hepatitis C virus.
  • Have not received prior treatment with an oncolytic virus therapy.
  • Have no prior organ transplantation including allogeneic stem-cell transplantation.

What to expect during the study

The study will consist of the following two treatment groups 1L Treatment Arm and 2L Treatment Arm.

1L Treatment Arm: locally advanced unresectable or metastatic HCC (no prior system therapy)

  • RP3 administered once every three weeks for up to eight doses in combination with atezolizumab and bevacizumab.

2L Treatment Arm: recurrent or metastatic HCC progressed on one prior system treatment

  • RP3 administered once every two weeks for the first four doses, followed by every three weeks for four doses in combination with atezolizumab and bevacizumab.

Patients will receive up to eight doses per course of RP3 in combination atezolizumab and bevacizumab.

Additional courses of RP3 may be administered every three weeks when applicable.

The study has different sections. They are:

ScreeningUp to 28 days
Treatment PeriodUp to 40 months
Follow-up PeriodUp to 3 years

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Contact Email: clinicaltrials@replimune.com

Contact Phone Number: +1 (781) 222 9570 (US); +44 1235 242 488 (UK)

RP3 and its use in combination with Atezolizumab and Bevacizumab is investigational, has not been proven to be safe and has not been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority.