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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received at least 1 dose of an RPx [RP1, RP2, RP3] | This is an observational study and there will be no clinical interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study with no interventions | Other | This is an observational study and there will be no clinical interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the long-term safety of patients treated with an RPx product | 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 | 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 | Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks |
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Inclusion Criteria:
Patients are eligible for inclusion in the study only if they meet all of the following criteria:
Exclusion Criteria:
Patients are excluded from the study if the following criterion applies:
1. Cannot comply with the requirements of the study.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials at Replimune | Contact | 1-781-222-9570 | Clinicaltrials@replimune.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093-0698 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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|
| Tasman Oncology Research | Recruiting | Southport | Queensland | 4215 | Australia |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |