Long-term safety follow-up of people previously treated with Replimune oncolytic immunotherapy
Follows adults with melanoma or advanced tumors previously given RP1, RP2, or RP3.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Key facts
- Where
- Heidelberg and Munich, GermanySee the 2 sites
- Phase
- Phase 4
Where in Germany
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Replimune, Inc.
- Trial code
- NCT06887348EU 2025-521621-33-00
- Record updated
- 12 January 2026
- Original description
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.Read full original descriptionShow less
Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
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.
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:; Cannot comply with the requirements of the study.