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NCT Number: NCT06887348

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

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.

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Key information

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Cannot comply with the requirements of the study.

Treatment and study plan

Observational study with no interventions

Other

This is an observational study and there will be no clinical interventions.

Other names: Observational Study

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials at Replimune

CONTACT

[email protected]

1-781-222-9570

Sponsors and collaborators

Lead sponsor

Replimune, Inc.

Industry

Registry information

Official study title

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

Acronym: RPx

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Mar 20, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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