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A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Sponsor: Replimune Inc.
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.
Official title: Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-12-12
Completion Date
2035-12
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
Observational study with no interventions
This is an observational study and there will be no clinical interventions.
Locations (2)
UC San Diego Moores Cancer Center
La Jolla, California, United States
Tasman Oncology Research
Southport, Queensland, Australia