A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3

NCT ID: NCT06887348

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2035-12-31

Brief Summary

This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.

Detailed Description

Long-term outcomes include detection of delayed adverse event(s) for any new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorder, rheumatologic or other autoimmune disorder, hematologic disorder, new incidence of infection related to RPx product and new incidence of herpetic-like infection. Patients with a suspected herpetic infection will be asked to provide a sample of the area of the suspected infection (using a swab), and also may be asked to provide additional biological samples (eg, a blood or urine sample to determine presence of RPx.) No study interventions will be administered in this observational study. Patients will be contacted by telephone every 3 months (Q3M) for 5 years from enrollment on this study. Participant visits may occur in person, over the phone, by video conference, or other technology.

Conditions

Melanoma; Metastatic Melanoma; Advanced Solid Tumor; Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who received at least 1 dose of an RPx [RP1, RP2, RP3]

This is an observational study and there will be no clinical interventions.

Observational study with no interventions

Intervention Type: OTHER

This is an observational study and there will be no clinical interventions.

Interventions

Observational study with no interventions

This is an observational study and there will be no clinical interventions.

Intervention Type: OTHER

Other Intervention Names

Observational Study

Eligibility Criteria

Inclusion Criteria

Patients are eligible for inclusion in the study only if they meet all of the following criteria:

1. Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.

2. Patient or patient's legal guardian has provided signed informed consent (or assent) as , which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

Patients are excluded from the study if the following criterion applies:

1. Cannot comply with the requirements of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Replimune Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status: RECRUITING

Tasman Oncology Research

Southport, Queensland, Australia

Site Status: RECRUITING

Countries

United States; Australia

Central Contacts

Clinical Trials at Replimune

Role: CONTACT

Clinicaltrials@replimune.com

1-781-222-9570

Other Identifiers

RPL-123-01

Identifier Type: -

Identifier Source: org_study_id