RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-08-01
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05733598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female patients are eligible if not pregnant (see IC #15) or breastfeeding and if one of the following applies 1) is a woman of non-childbearing potential (WNCBP) OR 2) is a woman of childbearing potential and must agree to use a highly effective contraception method during the treatment period, and for at least (a) 90 days after the last dose of RP2 or (b) 5 months after the last dose of atezolizumab, or (c) 6 months after the last dose of bevacizumab, or (d) 90 days after the last dose of durvalumab, whichever is longer.
  2. 2. Male patients are eligible to participate if they agree to the following during the study treatment period, and for at least 90 days after the last dose of RP2: refrain from donating fresh unwashed sperm plus either be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) OR must agree to use an external condom and also should advise their partner to use a highly effective method of contraception as a condom may break or leak.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials at Replimune
CONTACT
1-781-222-9570
hccstudy@replimune.com
Clinical Trials at Replimune
CONTACT
+44 1235 242 488
hccstudy@replimune.com

Principal Investigator

May Cho, MD
STUDY_DIRECTOR
Replimune Inc.

Study Locations (Sites)

Beverly Hills Cancer Center
Beverly Hills, California, 90211
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037
United States
Sylvester Comprehensive Cancer Center (University of Miami Hospital and Clinics)
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14236
United States
Montefiore Medical CenterMontefiore Medical Park
The Bronx, New York, 10461
United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
The West Clinic
Germantown, Tennessee, 38138
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States

Collaborators and Investigators

Sponsor: Replimune Inc.

  • May Cho, MD, STUDY_DIRECTOR, Replimune Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

  • Oncolytic virus
  • Hepatocellular Carcinoma
  • HCC
  • Biliary Tract Cancer
  • BTC

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Biliary Tract Cancer