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

NCT06590480 | Unknown

• 1 other identifier: RPL-EAP-001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 treatment.

Conditions

Advanced Melanoma

Keywords

Advanced melanoma; Cutaneous melanoma

Interventions

RP1 BIOLOGICAL

Genetically modified Herpes Simplex Type 1 Virus

Also known as: vusolimogene oderparepvec

Nivolumab BIOLOGICAL

Anti-PD-1 Monoclonal Antibody

Also known as: Opdivo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Replimune Inc.: lead

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tom Hash, MD

  Replimune Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12