Clinical trial · Observational
A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational study with no interventions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients who received at least 1 dose of an RPx [RP1, RP2, RP3]
- description
- This is an observational study and there will be no clinical interventions.
- interventionNames
- Other: Observational study with no interventions
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available