Long-term safety follow-up after RP1, RP2, or RP3 treatment
Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Replimune, Inc. Industry-sponsored |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT06887348 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
La Jolla, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.