Status:
NOT_YET_RECRUITING
A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Lead Sponsor:
Replimune Inc.
Conditions:
Melanoma
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Brief 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...
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 dis...
Eligibility Criteria
Inclusion
- Patients are eligible for inclusion in the study only if they meet all of the following criteria:
- Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
- 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
- Patients are excluded from the study if the following criterion applies:
- 1\. Cannot comply with the requirements of the study.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06887348
Start Date
November 1 2025
End Date
December 1 2035
Last Update
August 1 2025
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