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A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
NCT06887348 · Replimune, Inc.
In plain English
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Official title
Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
About this study
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.
Eligibility criteria
Inclusion Criteria:
Patients are eligible for inclusion in the study only if they meet all of the following criteria:
1. Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
2. 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:
1\. Cannot comply with the requirements of the study.
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-12-12
Estimated completion: 2035-12
Last updated: 2026-01-12
Interventions
Other: Observational study with no interventions
Primary outcomes
- • Evaluate the long-term safety of patients treated with an RPx product (Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks)
- • Identify any delayed adverse event(s) related to treatment with an RPx product (Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks)
- • Identify systemic HSV-1 infection related to treatment with an RPx product (Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks)
Sponsor
Replimune, Inc. · industry
Contacts & investigators
ContactClinical Trials at Replimune · contact · Clinicaltrials@replimune.com · 1-781-222-9570
All locations (2)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Tasman Oncology ResearchRecruiting
Southport, Queensland, Australia