Actively Recruiting

Age: 18Years +
All Genders
ID06887348

Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products

Led by Replimune, Inc. · Updated on 2026-01-12

50

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to monitor patients previously treated with Replimune oncolytic immunotherapy products, including RP1, RP2, and RP3, to assess long-term safety outcomes. It focuses on detecting delayed adverse events such as new cancers, worsening neurological or autoimmune disorders, blood disorders, infections linked to RPx products, and herpetic-like infections. The study is observational and involves patients who completed or withdrew from a prior Replimune-sponsored parent study. There are no treatments or interventions given in this study. Participants will be followed for five years after enrollment with check-ins every three months. These contacts may occur in person, by phone, video conference, or other technologies. If a herpetic infection is suspected, participants may be asked to provide samples from the affected area or other biological samples like blood or urine. During the study, researchers will evaluate safety by reviewing any delayed risks or adverse events related to the RPx products. Participants will be regularly contacted to monitor their health status, with outcome measures assessed every three months over the five-year period. This long-term follow-up helps identify any late effects of the treatments without requiring any study treatments or procedures beyond monitoring and sample collection when needed.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients have received at least one dose of an RPx product and completed or discontinued the parent study
  • Patient or legal guardian has signed informed consent or assent, agreeing to study requirements and restrictions
Not Eligible

You will not qualify if you...

  • Unable to comply with the study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Long-term Monitoring

Duration - 5 years

Participants are observed for long-term safety outcomes including delayed adverse events such as new malignancies, neurologic disorders, autoimmune disorders, hematologic disorders, infections related to RPx products, and herpetic-like infections. Samples may be collected if herpetic infection is suspected.

Quarterly contacts every 3 months (in-person, phone, video, or other technology)

Trial Site Locations

Total: 2 locations

1

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093-0698

Actively Recruiting

2

Tasman Oncology Research

Southport, Queensland, Australia, 4215

Actively Recruiting

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Research Team

C

Clinical Trials at Replimune

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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