A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3

Phase

N/A

Condition

Metastatic Melanoma

Abdominal Cancer

Liver Disease

Treatment

Observational study with no interventions

Clinical Study ID

NCT06887348

RPL-123-01

Ages > 18
All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 ordiscontinued 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 theinformed consent form (ICF) and in this protocol.

Exclusion

Exclusion Criteria:

Patients are excluded from the study if the following criterion applies:

Cannot comply with the requirements of the study.

Study Design

Observational study with no interventions

December 12, 2025

December 31, 2035

Study 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 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.

Connect with a study center

Tasman Oncology Research
Southport 2148928, Queensland 2152274 4215
Australia
Active - Recruiting
UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093-0698
United States
Active - Recruiting

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