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

Overview

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.

Interventions

• Other Observational study with no interventions
  This is an observational study and there will be no clinical interventions.

Primary outcome measures

• Evaluate the long-term safety of patients treated with an RPx product [Time frame: 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 [Time frame: 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 [Time frame: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks]

Eligibility criteria

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:

1\. Cannot comply with the requirements of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• UC San Diego Moores Cancer Center — La Jolla

Australia · 1 center

• Tasman Oncology Research — Southport

Identifiers

NCT: NCT06887348 · RPL-123-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗