Long-term safety follow-up after RP1, RP2, or RP3 treatment
Official title: Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
Run by Replimune, Inc. · NCT06887348 · Data updated 2026-11-12
This study will follow people with melanoma or other advanced solid tumors who previously received RP1, RP2, or RP3 to see if any delayed side effects appear over five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Replimune, Inc. Industry-sponsored |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Status | Recruiting |
| Started | December 12, 2025 |
| Main results expected | December 2030 |
| Study ends | December 2035 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT06887348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients who previously received at least one dose of an RPx product in a Replimune-sponsored parent study and who can provide informed consent and comply with five years of follow-up are the intended participants.
✕Probably not a fit
People who never received an RPx product, cannot comply with long-term follow-up, or are seeking direct therapeutic benefit are unlikely to receive personal medical benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a noninterventional long-term follow-up study that tracks patients for five years after they received at least one dose of an RPx product in a Replimune-sponsored parent study. Eligible participants are rolled over after completing or withdrawing from the parent interventional study and will have no new therapies administered as part of this follow-up. Participants are contacted every three months and may have visits in person, by phone, or via video; suspected herpetic infections may prompt collection of swabs and other biological samples. The study focuses on detecting delayed adverse events such as new malignancies, neurologic or autoimmune disorders, hematologic problems, infections related to RPx, and herpetic-like infections.
Why it matters
Potential benefit: If successful, this follow-up could identify late or rare adverse effects of RPx therapies and improve monitoring and safety guidance for future patients.
How similar studies have gone: Long-term safety monitoring is a standard practice after oncolytic and gene therapies and has previously identified delayed adverse events, but comprehensive RPx-specific long-term data are still emerging.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
Tasman Oncology Research
Southport, Queensland, Australia Recruiting
Study contacts
- Study coordinator: Clinical Trials at Replimune
- Email: Clinicaltrials@replimune.com
- Phone: 1-781-222-9570
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.