MelanomaRPxNCT06887348
A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
An observational study of Melanoma and Metastatic Melanoma, run by Replimune, Inc. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Metastatic Melanoma, Advanced Solid Tumor
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Dec 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patients are excluded from the study if the following criterion applies:
- 1. Cannot comply with the requirements of the study.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
Soo Park, MD
Australia1 site, 1 recruiting
- Recruiting
Tasman Oncology Research
Southport, Queensland, 4215
Andrew Hill, MD
About this study
Official title: Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
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.
Read the 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.
- Being tested
- Observational study with no interventions
- Keywords
- Advanced solid tumors, Immunotherapy, Immuno-oncology, Oncolytic virus, Oncolytic immuno-gene therapy, Hepatocellular Carcinoma, Cutaneous Melanoma, Anti-PD1 failed, Non-melanoma Skin Cancer, Melanoma (skin)
- Medical subject headings
- Melanoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study with no interventionsOther
Also called Observational Study
This is an observational study and there will be no clinical interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational study with no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the long-term safety of patients treated with an RPx product
Measured: 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
Measured: 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
Measured: Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start12 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Replimune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887348
- Sponsor's protocol ID
- RPL-123-01
- Acronym
- RPx
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
- ClinicalTrials.gov ID
- NCT06887348
- Acronym / sponsor ID
- RPx / RPL-123-01
- Keywords
- Advanced solid tumors, Immunotherapy, Immuno-oncology, Oncolytic virus, Oncolytic immuno-gene therapy, Hepatocellular Carcinoma, Cutaneous Melanoma, Anti-PD1 failed
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Replimune, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received at least 1 dose of an RPx [RP1, RP2, RP3] | – | Other: Observational study with no interventionsThis is an observational study and there will be no clinical interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 1. Cannot comply with the requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study with no interventionsAlso: Observational StudyThis is an observational study and there will be no clinical interventions. | Other | Patients who received at least 1 dose of an RPx [RP1, RP2, RP3] |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Metastatic Melanoma, run by Replimune, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials at Replimune (1-781-222-9570, Clinicaltrials@replimune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.