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

NCT06887348 | Recruiting FDA Drug

• 1 other identifier: RPL-123-01
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Melanoma; Metastatic Melanoma; Advanced Solid Tumor; Hepatocellular Carcinoma

Keywords

Advanced solid tumors; Immunotherapy; Immuno-oncology; Oncolytic virus; Oncolytic immuno-gene therapy; Hepatocellular Carcinoma; Cutaneous Melanoma; Anti-PD1 failed; Non-melanoma Skin Cancer; Melanoma (skin)

Outcome Measures

Primary Outcomes (3)

• Evaluate the long-term safety of patients treated with an RPx product

  Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks

• Identify any delayed adverse event(s) related to treatment with an RPx product

  Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks

• Identify systemic HSV-1 infection related to treatment with an RPx product

  Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks

Study Arms (1)

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.

Other: Observational study with no interventions

Interventions

Observational study with no interventions OTHER

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

Also known as: Observational Study

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are eligible for inclusion in the study only if they meet all of the inclusion criteria. Deviations from the entry criteria that would be considered a protocol waiver or exemption are not permitted.

You may qualify if:

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

You may not qualify if:

• Patients are excluded from the study if the following criterion applies:
• \. Cannot comply with the requirements of the study.

Sponsors & Collaborators

• Replimune Inc.: lead

Study Sites (2)

UC San Diego Moores Cancer Center

La Jolla, California, 92093-0698, United States

RECRUITING

Tasman Oncology Research

Southport, Queensland, 4215, Australia

RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Hepatocellular

Interventions

Observation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Clinical Trials at Replimune

CONTACT

1-781-222-9570; Clinicaltrials@replimune.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (1)