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

January 9, 2026 updated by: Replimune Inc.

Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Tasman Oncology Research
        • Principal Investigator:
          • Andrew Hill, MD
  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Soo Park, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
This is an observational study and there will be no clinical interventions.
Other Names:
  • Observational Study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPL-123-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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