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Advanced MelanomaRPL-EAP-001NCT06590480

An Expanded Access Program for VO (RP1) in Combination With Nivolumab in Patients With Advanced Melanoma

A study testing RP1 and Nivolumab in people with Advanced Melanoma, run by Replimune, Inc..

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this EAP is to provide expanded access (i.e., before marketing authorization) to vusolimogene oderparepvec (VO; herein referred to as VO) plus standard-of-care (SOC), nivolumab, for eligible patients diagnosed with advanced melanoma, who, in their treating physician's opinion, could benefit from this… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
RP1 and Nivolumab
How many people
Not given
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

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
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the program:
  • Voluntary agreement to provide written informed consent and a willingness and ability to comply with protocol requirements.
  • Male or female ≥18 years old.
  • Histologically, cytologically, or clinically confirmed diagnosis of unresectable or metastatic Stage IIIb though IV/M1a through M1d cutaneous melanoma, as per AJCC staging system, 8th edition.
  • Prior treatment with an anti-PD-1-containing regimen as monotherapy or in combination (i.e., LAG-3).
  • Has ≥ 1 measurable and injectable lesion of ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes).
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  • Has adequate hematologic function including:
  • White blood cell count ≥ 2.0 × 109/L
  • Absolute neutrophil count ≥ 1.5 × 109/L
  • Platelet count ≥ 75 × 109/L
  • Hemoglobin ≥ 8 g/dL (without packed red blood cell transfusion within 2 weeks of dosing)
  • Has adequate hepatic function, including:
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN; < 2.0 × ULN for patients with known Gilbert syndrome or liver metastases)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN (≤ 5.0 × ULN, if liver metastases are present)
  • Alkaline phosphatase (ALP) ≤ 2.5 × ULN (or ≤ 5.0 × ULN, if liver or bone metastases are present)
  • Has adequate renal function, defined as serum creatinine ≤ 1.5 × ULN or creatinine clearance ≤ 30.0 mL/minute/1.73 m2 (measured using Chronic Kidney Disease Epidemiology collaboration [CKD-EPI] formula)
  • Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Note: Patients which are on chronic anticoagulant therapy may be enrolled if the target international normalized ratio (INR) is ≤ 2.5. for patients requiring deep injection of VO, the INR must be < 1.5 at the time of injection.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1.
  • Life expectancy of ≥ 3 months.
  • Male and female patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirement during treatment and for at 90 days after last dose of VO, or 5 months after last dose of nivolumab.
  • Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU/L or equivalent units β-hCG within 7 days before the first dose of program treatment.

Who cannot join

  • Patients meeting any of the following exclusion criteria will not be included in the program:
  • Eligibility for, or previous randomization in the Replimune clinical trial NCT06264180 (IGNYTE3 trial).
  • Prior treatment with anti-CTLA-4-directed therapy.
  • More than 2 lines of systemic therapy for advanced melanoma.
  • Known acute or chronic hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known acute or chronic hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected). Note: Patients who have been effectively treated are eligible for enrolment. Patients must be negative for HBsAg and HCV RNA.
  • Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.
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  • Active significant herpetic infections or prior complications of herps simplex virus (HSV)-1 infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous [IV]) antivirals with known antiherpetic activity (e.g., acyclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of program treatment.
  • Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days before dosing.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis at time of screening. Patients with known CNS metastases are eligible if they have received SOC therapy for CNS disease (such as stereotactic radiosurgery or radical surgical resection followed by radiotherapy) and have disease stability on 2 subsequent scans performed at least at a 4-week interval.
  • Evidence of spinal cord compression or at high risk of spinal cord compression.
  • Serum lactate dehydrogenase > 2 × ULN.
  • Major surgery ≤ 2 weeks before starting program treatment.
  • No concurrent active malignancy requiring treatment.
  • History of significant cardiac disease including myocarditis or congestive heart failure (defined as New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, cerebral vascular accident, or myocardial infarction within 6 months from first dose of VO.
  • History of life-threatening toxicity related to prior immune therapy except those that are unlikely to recur with standard countermeasures (e.g., hormone replacement after adrenal crisis).
  • History or evidence of psychiatric, substance abuse (including IV substance abuse) or any other clinically significant disorder, condition, or disease (with the exception of those described above) that, in the opinion of the treating physician would pose a risk to patient safety or interfere with the program evaluation, procedures, or completion.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the program, interfere with the patient's participation for the full duration, or is not in the best interest of the patient to participate, in the opinion of the treating physician.
  • Active, known, or suspected autoimmune disease requiring systemic treatment.
  • History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  • Prior oncolytic virus therapy or other therapy given by intratumoral administration.
  • Was administered a live vaccine ≤ 28 days before the first dose of program treatment.
  • Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.
  • Is currently participating in or has participated in a study of an investigational agent within 4 weeks before the first dose of program treatment.
  • Has received prior radiotherapy and has not recovered from radiotherapy.
  • Conditions requiring treatment with immunosuppressive doses (> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy 14 days before enrollment. Note: Patients who require a brief course (≤ 7 days) or corticosteroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic corticosteroids are permitted, only if the dose does not exceed 10 mg/day prednisone equivalent.
  • History of allergy or sensitivity to program drug components (VO, nivolumab) or prior monoclonal antibody treatment.
  • Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks before treatment.
  • Patient is deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

About this study

Official title: An Expanded Access Program - Real-world Data Collection for VO in Combination With Nivolumab in Patients With Advanced Melanoma That Has Progressed on an Anti-PD-1 Containing Treatment Regimen

The purpose of this EAP is to provide expanded access (i.e., before marketing authorization) to vusolimogene oderparepvec (VO; herein referred to as VO) plus standard-of-care (SOC), nivolumab, for eligible patients diagnosed with advanced melanoma, who, in their treating physician's opinion, could benefit from this treatment.

Read the detailed description

The objective of treating with VO is to directly reduce or eliminate tumors by lytic virus replication and to induce a systemic anti-tumor immune response leading to tumor immunity and durable clinical responses. Limited treatment options are available to those patients with advanced melanoma who have progressed while on an anti-PD-1 therapy regimen, and the duration of progression-free survival (PFS) is less than 6 months with overall survival (OS) being less than 3 years. The mechanism of VO complements that of anti-PD-1 therapy such that combining VO with an anti-PD-1 agent, such as nivolumab, will increase the number of tumor-reactive T cells (through the action of VO) and relieve CD8-T cell exhaustion (through the action of the anti-PD-1 therapy). Combining VO with nivolumab, is supported by evidence in syngeneic immune-competent murine models demonstrating an increased reduction in tumor volume compared with either VO or anti-PD-1 monotherapy.

Being tested
RP1, Nivolumab
Keywords
Advanced melanoma, Cutaneous melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RP1Biological

    Also called vusolimogene oderparepvec

    Genetically modified Herpes Simplex Type 1 Virus

  • NivolumabBiological

    Also called Opdivo

    Anti-PD-1 Monoclonal Antibody

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT06590480
Sponsor's protocol ID
RPL-EAP-001
Other IDs
RPL-EAP-001
Acronym
RPL-EAP-001
Status last verified
Dec 2025
First submitted
6 Sep 2024
Last updated
18 Dec 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing RP1 and Nivolumab in people with Advanced Melanoma, run by Replimune, Inc..

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 21 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06590480.

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 18 Dec 2025.

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