A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Recruiting · NCT06887348 · Observational (researchers observe without assigning treatment) · Lead sponsor: Replimune, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Patients are excluded from the study if the following criterion applies:
- \. Cannot comply with the requirements of the study.
Where it is running
2 locations listed across 1 US state.
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Tasman Oncology Research - Southport, Queensland, Australia