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Advanced MelanomaPhase 3NCT06264180

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

A Phase 3 study testing Vusolimogene Oderparepvec, Nivolumab and Nivolumab + Relatlimab in people with Advanced Melanoma, run by Replimune, Inc. at 81 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
Vusolimogene Oderparepvec, Nivolumab and Nivolumab + Relatlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
81 sitesin 7 countries
Study dates
11 Jul 2024to 31 Mar 2031
Phase
Phase 3
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • I 1. Male or female who is 12 years of age or older at the time of signed informed consent.
  • I 2. Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma, as per AJCC staging system, 8th edition).
  • I 3. Confirmed disease progression (PD) on an anti-PD-1 antibody treatment and an anti-CTLA-4 antibody treatment, administered as either a combination regimen (eg, nivolumab + ipilimumab) or in sequence.
  • Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks (note: treatment with prior pembrolizumab therapy when administered every 6 weeks must have continued for a minimum of 12 weeks [ie, 2 treatment cycles]). Any number of doses of prior anti-CTLA-4 therapy may have been administered in combination with an anti-PD-1. The anti-PD-1-containing therapy must be the immediate prior line of treatment before randomization (for patients with BRAF mutation, see I 4).
  • Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody (eg, due to documented clinically significant comorbidities or history of immune-related adverse events) are eligible for the study if they have confirmed PD on an anti-PD-1 antibody (including unresectable disease relapse during adjuvant therapy or < 6 months from completion of adjuvant therapy).
  • Disease progression must have been confirmed and documented using clinical or radiological assessment by 2 assessments at least 4 weeks apart while being treated with an anti-PD-1 antibody and an anti-CTLA-4 antibody. Radiological confirmation of PD can occur during the Screening period for this study. Treatment with prior anti-PD-1 therapy must have continued from the time of initial tumor progression until confirmation of PD (ie, such that no doses of anti-PD-1 therapy were missed).
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  • Note: If radiographic progression at the initial scan where PD was documented is accompanied by clear clinical progression, defined as a decline in performance status directly attributed to disease or increased disease-related symptoms, anti-PD-1 therapy does not need to continue. For patients with documented PD while on adjuvant therapy with an anti-PD-1 therapy, a confirmatory biopsy can be used in place of a confirmatory scan.
  • I 4. Has documented BRAF V600 mutation status or must consent to BRAF V600 mutation testing per local institutional standards during the Screening period. Patients with BRAF mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to randomization, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition or prior toxicity.
  • Note: Prior exposure to BRAF-directed therapy (with or without a MEK inhibitor) includes treatment in the adjuvant setting. One line of BRAF-directed therapy (with or without a MEK inhibitor) can be the most recent systemic treatment administered before randomization.
  • I 5. Has least 1 measurable tumor of ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes) and injectable lesion(s) of at least 1 cm in longest diameter.
  • I 6. Has adequate hematologic function, including:
  • White blood cell (WBC) count ≥ 2.0 × 109/L
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • Platelet count ≥ 75 × 109/L
  • Hemoglobin ≥ 8 g/dL (without packed red blood cell [RBC] transfusion within 2 weeks of dosing)
  • I 7. 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 (or ≤ 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) I 8. Has adequate renal function, defined as serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 3 0 mL/minute/1.73 m2 (measured using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
  • I 9. 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 who are on chronic anticoagulant therapy may be randomized if the target INR is ≤ 2.5. For patients requiring deep injection of VO, the INR must be <1.5 at the time of injection.
  • I 10. ECOG performance status (PS) 0 to 1 for patients 18 and older or a Lansky PS ≥ 80 for patients 12 to 17 years of age.
  • I 11. Life expectancy of at least 3 months. I 12. Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirements during the treatment period and for at least 6 months after the last dose of any study treatment.
  • I 13. 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 or β hCG within 7 days before the first dose of study treatment.
  • I 14. Capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form (ICF)

Who cannot join

  • E 1. Primary mucosal or uveal melanoma. E 2. More than 2 lines of systemic therapy for advanced melanoma. Note: One additional line of anti-PD-1 therapy in the adjuvant or neoadjuvant setting is allowed if the patient was free of treatment and of PD for at least 6 months and subsequently had confirmed PD on an anti-PD-1 and an anti-CTLA-4 antibody therapy administered in the advanced setting.
  • E 3. 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 RNA [qualitative] is detected).
  • Note: Patients who have been effectively treated are eligible for randomization. Patients must be negative for HBsAg and HCV RNA.
  • E 4. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.
  • E 5. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
  • Note: Patients with sporadic cold sores may be randomized if no active cold sores are present at the time of first dose of study treatment.
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  • E 6. Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to the first dose.
  • E 7. Evidence of spinal cord compression or at high risk of spinal cord compression.
  • E 8. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis at time of screening. Patients with known central nervous system metastases are eligible if they have received standard-of-care therapy for central nervous system disease (such as stereotactic radiosurgery or radical surgical resection followed by radiotherapy) and have evidence of disease stability on 2 subsequent scans performed at least at a 4-week interval.
  • E 9. Serum lactate dehydrogenase (LDH) > 2 × ULN. E 10. Major surgery ≤ 2 weeks prior to starting study treatment. Note: Patients must have recovered adequately from all acute complications of all previous procedures prior to randomization.
  • E 11. Prior malignancy active within the previous 3 years, except for locally curable cancers that have apparently been cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ (without invasive component) of the prostate, cervix, or breast.
  • E 12. 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.
  • E 13. History of life-threatening toxicity related to prior immune therapy except those that are unlikely to recur with standard countermeasures (eg, hormone replacement after adrenal crisis).
  • E 14. 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 Investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
  • E 15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
  • E 16. Active, known, or suspected autoimmune disease requiring systemic treatment.
  • E 17. History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  • E 18. Prior oncolytic virus therapy or other therapy given by intratumoral administration.
  • E 19. Requires chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
  • E 20. Has received a live vaccine within 28 days prior to the first dose of study treatment.
  • E 21. Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.
  • E 22. Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment.
  • E 23. Has received prior radiotherapy within 2 weeks of start of study treatment or has not recovered from radiotherapy.
  • E 24. 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 randomization.
  • Note: Patients who require a brief course (≤ 7 days) or corticosteroids (eg, 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.
  • E 25. History of allergy or sensitivity to study drug components (VO, nivolumab, pembrolizumab, or relatlimab) or to cisplatin or carboplatin or paclitaxel (dependent on cohort) or prior monoclonal antibody treatment.
  • E 26. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to treatment.
  • E 27. Is a person who is deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

Trial locations and contacts

81 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials at Replimune contact

1-781-222-9570

clinicaltrials@replimune.com

81 sites in 7 countries

United States50 sites, 44 recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    David Lawson, MD

    Recruiting

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

    Theresa Michelle Medina, MD

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Michael Wong, MD

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Hibba tul Rehman, MD

    Recruiting

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

    Withdrawn

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Frances Collichio, MD

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Sunandana Chandra, MD

    Recruiting

  • The Ohio State University- Martha Morehouse Tower

    Columbus, Ohio, 43210

    Merve Hasanov, MD

    Recruiting

  • Texas Oncology

    Dallas, Texas, 75246

    Charles Cowey, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Daniel Wang, MD

    Recruiting

  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan, 48202

    Withdrawn

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Georgia Beasley, MD

    Recruiting

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

    Ryan Weight, DO

    Recruiting

  • West Cancer Center and Research Institute

    Germantown, Tennessee, 38138

    David Portnoy, MD, FACP

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Fade Mahmoud, MD, FACP

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Gerald Paul Wright, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Andrew L. Pecora, MD

    Recruiting

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

    Atif Hussein, MD

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Isabella Glitza, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Mohammed Milhem, MBBS

    Recruiting

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

    Konstantinos Chouliaras, MD

    Recruiting

  • University of Tennessee

    Knoxville, Tennessee, 37920

    Ardy Davarifar, MD, PhD

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Gregory Daniels, MD

    Recruiting

  • Northwell Health, R.J. Zuckerberg Cancer Center

    Lake Success, New York, 11042

    Shaheer Khan, MD

    Recruiting

  • Dartmouth Hitchcock Cancer Center

    Lebanon, New Hampshire, 03756

    Keisuke Shirai, MD

    Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

    Omid Hamid, MD

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Gino In, MD

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

    Bartosz Chmielowski, MD

    Recruiting

  • University of Louisville Brown Cancer Center

    Louisville, Kentucky, 40202

    Jason Chesney, MD, PhD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Benjamin Manning, MD

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Joanna Kolodney, MD

    Recruiting

  • Morristown Medical Center - Atlantic Health System

    Morristown, New Jersey, 07960

    Eric Whitman, MD

    Recruiting

  • Intermountain Health

    Murray, Utah, 84107

    Caroline Nebhan, MD, PhD

    Recruiting

  • UC Irvine Health, Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Thuy Tran, MD

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    Allison Betof-Warner, MD

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Withdrawn

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Rino Seedor, MD

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Anthony Olszanski, MD

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15232

    Yana Najjar, MD

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Maria Constantinou, MD

    Recruiting

  • Sutter Medical Group

    Sacramento, California, 95816

    Withdrawn

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Elliot Asare, MD

    Recruiting

  • San Francisco Oncology Associates

    San Francisco, California, 94115

    Kevin Kim, MD

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

    Katy Tsai, MD

    Recruiting

  • St. George Regional Hospital

    St. George, Utah, 84790

    Withdrawn

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794

    Withdrawn

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Nikhil Khushalani, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Yvonne Saenger, MD

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Suthee Rapisuwon, MD

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Gary Doolittle, MD

    Recruiting

Other trials in United States

Germany10 sites, 10 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

    Thomas Eigentler, MD

    Recruiting

  • University Hospital Carl Gustav Carus Dresden

    Dresden, 01307

    Friedegund Meier, MD

    Recruiting

  • Helios Klinik

    Erfurt, 99089

    Rudolf Herbst, MD

    Recruiting

  • Universitätsklinikum Essen

    Essen, 45147

    Dirk Schadendorf, MD

    Recruiting

  • Universitätsklinikum Medical Center

    Hamburg, 20246

    Christoffer Gebhardt, MD

    Recruiting

  • Universitätsklinikum Hospital Heidelberg

    Heidelberg, 69120

    Jessica Hassel, MD

    Recruiting

  • University of Kiel

    Kiel, 24105

    Katharina Kaehler, MD

    Recruiting

  • Universitatsklinikum Mainz Hautklinik und Poliklinik

    Mainz, 55131

    Stephan Grabbe, MD

    Recruiting

  • LMU München - Klinik and Poliklinik für Dermatologie und Allergologie, Dermatoonkologie

    München, 80337

    Lucie Heinzerling, MD

    Recruiting

  • Universitätsklinikum of Tübingen

    Tübingen, 72076

    Andreas Meiwes, MD

    Recruiting

Other trials in Germany

France7 sites, 7 recruiting

  • CHU de Bordeaux, Hôpital Saint-André

    Bordeaux, 33075

    Caroline Dutriaux, MD

    Recruiting

  • CHU de Lille

    Lille, 59000

    Laurent Mortier, MD

    Recruiting

  • Hopital de La Timone

    Marseille, 13005

    Caroline Gaudy, MD

    Recruiting

  • CHU Nice

    Nice, 06200

    Henri Montaudie, MD

    Recruiting

  • Hôpital Saint Louis - AP-HP

    Paris, 75010

    Celeste Lebbe, MD

    Recruiting

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

    Stephane Dalle, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Caroline Robert, MD

    Recruiting

Other trials in France

Spain6 sites, 6 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Eva Muñoz Couselo, MD

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Ana Arance, MD

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, 30120

    Pablo Cerezuela, MD

    Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027

    Eduardo Castañón, MD

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Guillermo de Velasco, MD

    Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008

    Eduardo Castañón, MD

    Recruiting

Other trials in Spain

United Kingdom5 sites, 5 recruiting

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

    Rafael Bach-Mora, MD

    Recruiting

  • Royal Free London NHS Foundation Trust - Royal Free Hospital

    London, NW3 2QG

    Antonio Rullan, MD

    Recruiting

  • Guy's & St. Thomas' NHS Foundation Trust

    London, SE1 9RT

    Benjamin Shum, MD

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    James Larkin, MD

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Patricio Serra, MD

    Recruiting

Other trials in United Kingdom

Poland2 sites, 2 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Kamil Drucis, MD

    Recruiting

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-781

    Piotr Rutkowski, MD

    Recruiting

Other trials in Poland

Greece1 site, 1 recruiting

  • National and Kapodistrian University of Athens, General Hospital of Athens "Laiko"

    Athens, 11527

    Helen Gogas, MD

    Recruiting

Other trials in Greece

About this study

Official title: Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

Being tested
Vusolimogene Oderparepvec, Nivolumab, Nivolumab + Relatlimab, Pembrolizumab, Single-agent chemotherapy

What participants receive

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

  • Vusolimogene OderparepvecBiological

    Also called VO, RP1

    Genetically modified Herpes Simplex Type 1 Virus.

  • NivolumabBiological

    Also called Opdivo

    Anti-PD-1 Monoclonal Antibody

  • Nivolumab + RelatlimabBiological

    Also called Opdualag

    Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.

  • PembrolizumabBiological

    Also called Keytruda

    A programmed death receptor-1 (PD-1)-blocking antibody indicated.

  • Single-agent chemotherapyDrug

    Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.

Study groups in NCT06264180
Study groupRoleWhat they receive
VO + nivolumabExperimentalNot described
Receives: Biological: Vusolimogene Oderparepvec; Biological: Nivolumab
Physicians ChoiceActive comparatorChoosing from 1 of the following (to be consistent with approved label and/or applicable local clinical guidelines): * Nivolumab + relatlimab (as Opdualag) * Anti-PD-1 monotherapy (nivolumab or pembrolizumab) * Single-agent chemotherapy (dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel)
Receives: Biological: Nivolumab; Biological: Nivolumab + Relatlimab; Biological: Pembrolizumab; Drug: Single-agent chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Time from the date of randomization to death due to any cause

    Measured: Assessed up to January 2029, approximately 55 months

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    The time from the date of randomization to the earliest date of the objective documentation of progressive disease (PD) per RECIST v1.1 or death due to any cause.

    Measured: Assessed up to January 2029, approximately 55 months

  2. Objective Response Rate (ORR)

    The proportion of randomized patients with best overall response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria.

    Measured: Assessed up to January 2029, approximately 55 months

Timeline

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

  1. First posted16 Feb 2024
  2. Study start11 Jul 2024
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion31 Mar 2031 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06264180
Sponsor's protocol ID
RP1-104
Status last verified
Jul 2026
First submitted
29 Jan 2024
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vusolimogene Oderparepvec, Nivolumab and Nivolumab + Relatlimab in people with Advanced Melanoma, run by Replimune, Inc. at 81 sites in 7 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 24 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Germany, France, Spain, United Kingdom and 2 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Overall Survival (OS) (time frame: Assessed up to January 2029, approximately 55 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06264180.

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 15 Jul 2026.

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