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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.
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 disorder, hematologic disorder, new incidence of infection related to RPx product and new incidence of herpetic-like infection. Patients with a suspected herpetic infection will be asked to provide a sample of the area of the suspected infection (using a swab), and also may be asked to provide additional biological samples (eg, a blood or urine sample to determine presence of RPx.) No study interventions will be administered in this observational study. Patients will be contacted by telephone every 3 months (Q3M) for 5 years from enrollment on this study. Participant visits may occur in person, over the phone, by video conference, or other technology.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UC San Diego Moores Cancer Center
La Jolla, California, United States
Tasman Oncology Research
Southport, Queensland, Australia
Start Date
December 12, 2025
Primary Completion Date
December 1, 2030
Completion Date
December 1, 2035
Last Updated
January 12, 2026
50
ESTIMATED participants
Observational study with no interventions
OTHER
Lead Sponsor
Replimune Inc.
NCT05720117
NCT06898450
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06066138