Actively Recruiting
Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
Led by Replimune, Inc. · Updated on 2026-01-12
50
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to monitor patients previously treated with Replimune oncolytic immunotherapy products, including RP1, RP2, and RP3, to assess long-term safety outcomes. It focuses on detecting delayed adverse events such as new cancers, worsening neurological or autoimmune disorders, blood disorders, infections linked to RPx products, and herpetic-like infections. The study is observational and involves patients who completed or withdrew from a prior Replimune-sponsored parent study. There are no treatments or interventions given in this study. Participants will be followed for five years after enrollment with check-ins every three months. These contacts may occur in person, by phone, video conference, or other technologies. If a herpetic infection is suspected, participants may be asked to provide samples from the affected area or other biological samples like blood or urine. During the study, researchers will evaluate safety by reviewing any delayed risks or adverse events related to the RPx products. Participants will be regularly contacted to monitor their health status, with outcome measures assessed every three months over the five-year period. This long-term follow-up helps identify any late effects of the treatments without requiring any study treatments or procedures beyond monitoring and sample collection when needed.
CONDITIONS
Brief Title
A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients have received at least one dose of an RPx product and completed or discontinued the parent study
- Patient or legal guardian has signed informed consent or assent, agreeing to study requirements and restrictions
You will not qualify if you...
- Unable to comply with the study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 5 years
Participants are observed for long-term safety outcomes including delayed adverse events such as new malignancies, neurologic disorders, autoimmune disorders, hematologic disorders, infections related to RPx products, and herpetic-like infections. Samples may be collected if herpetic infection is suspected.
Quarterly contacts every 3 months (in-person, phone, video, or other technology)
Trial Site Locations
Total: 2 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698
Actively Recruiting
2
Tasman Oncology Research
Southport, Queensland, Australia, 4215
Actively Recruiting
Research Team
C
Clinical Trials at Replimune
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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