Recruiting

Observational Study

Sponsor:

Replimune Inc.

Code:

NCT06887348

Conditions

Melanoma

Metastatic Melanoma

Advanced Solid Tumor

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational study with no interventions

Study Details

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

Study ID

NCT06887348

Start date

Dec 12, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Observational study with no interventions

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

Primary outcome measure

  • Evaluate the long-term safety of patients treated with an RPx product [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks ]

Central Contacts and Locations

Central contacts

Clinical Trials at Replimune

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

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093-0698

Principal Investigator:

Soo Park, MD

More Information

Sponsor

Replimune Inc.

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Replimune Inc. on 2026-01-12.