Clinical trial NCT06887348: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Official title: Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Melanoma
Metastatic Melanoma
Advanced Solid Tumor
Hepatocellular Carcinoma
Keywords: Advanced solid tumors
Immunotherapy
Immuno-oncology
Oncolytic virus
Oncolytic immuno-gene therapy
Hepatocellular Carcinoma
Cutaneous Melanoma
Anti-PD1 failed
Non-melanoma Skin Cancer
Melanoma (skin)
Lead sponsor: Replimune Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are eligible for inclusion in the study only if they meet all of the inclusion criteria.

Deviations from the entry criteria that would be considered a protocol waiver or exemption are not permitted.

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Evaluate the long-term safety of patients treated with an RPx product
timeFrame: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
measure: Identify any delayed adverse event(s) related to treatment with an RPx product
timeFrame: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
measure: Identify systemic HSV-1 infection related to treatment with an RPx product
timeFrame: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: