Actively Recruiting
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
Led by Replimune, Inc. · Updated on 2026-03-13
400
Participants Needed
73
Research Sites
529 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 12 years or older
- Histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV cutaneous melanoma
- Confirmed progression on anti-PD-1 and anti-CTLA-4 antibody treatments administered either combined or in sequence
- Prior anti-PD-1 therapy continued for at least 8 weeks (12 weeks if pembrolizumab every 6 weeks)
- Patients not candidates for anti-CTLA-4 therapy with confirmed progression on anti-PD-1 antibody
- Disease progression confirmed by two assessments at least 4 weeks apart
- Documented BRAF V600 mutation status or consent to testing; prior BRAF-directed therapy if mutated
- At least one measurable tumor ≥1 cm and injectable lesion(s) ≥1 cm
- Adequate blood counts: WBC ≥ 2.0 x 10⁹/L, ANC ≥ 1.5 x 10⁹/L, platelets ≥ 75 x 10⁹/L, hemoglobin ≥ 8 g/dL
- Adequate liver function: bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN with Gilbert syndrome or liver metastases), AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN with liver metastases), ALP ≤ 2.5 x ULN (≤ 5.0 x ULN with liver or bone metastases)
- Adequate kidney function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min/1.73 m²
- Prothrombin time ≤ 1.5 x ULN or INR ≤ 1.3; patients on anticoagulants allowed with target INR ≤ 2.5
- ECOG performance status 0 to 1 for adults or Lansky score ≥ 80 for ages 12 to 17
- Life expectancy of at least 3 months
- Agreement to use effective contraception during treatment and for 6 months after
- Negative pregnancy test for women of childbearing potential within 7 days before treatment
- Ability to give signed informed consent and comply with study requirements
You will not qualify if you...
- Primary mucosal or uveal melanoma
- More than 2 prior lines of systemic therapy for advanced melanoma (with exceptions)
- Known acute or chronic hepatitis B or C infection (unless effectively treated)
- Known HIV infection (unless required by local authorities)
- Active significant herpetic infections or prior serious HSV-1 complications
- Recent serious infections requiring IV antibiotics or antimicrobial treatment within 14 days
- Evidence or high risk of spinal cord compression
- Active central nervous system metastases unless stable after treatment
- Serum lactate dehydrogenase (LDH) greater than 2 times the upper limit of normal
- Major surgery within 2 weeks before starting treatment
- Active malignancy within the past 3 years except certain cured cancers
- History of significant cardiac disease or recent serious cardiac events
- History of life-threatening toxicity related to prior immune therapy
- Psychiatric or substance abuse disorders that may interfere with study participation
- Conditions or therapies that may confound study results or participation
- Active autoimmune disease requiring systemic treatment
- History or current pneumonitis requiring steroids
- Prior oncolytic virus or intratumoral therapy
- Chronic use of systemic antivirals with antiherpetic activity
- Received live vaccine within 28 days before treatment
- Recent systemic anticancer therapy within 4 weeks or 5 half-lives
- Participation in other investigational studies within 4 weeks
- Recent radiotherapy within 2 weeks or not recovered from it
- Need for immunosuppressive corticosteroid doses above 10 mg prednisone equivalent
- Allergy or sensitivity to study drug components or similar agents
- Recent use of botanical treatments intended for health support
- Individuals deprived of freedom by legal or emergency order or hospitalized involuntarily
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 73 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
3
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
4
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
6
UC Irvine Health, Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
8
Sutter Medical Group
Sacramento, California, United States, 95816
Actively Recruiting
9
San Francisco Oncology Associates
San Francisco, California, United States, 94115
Actively Recruiting
10
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
11
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Actively Recruiting
12
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States, 80113
Actively Recruiting
13
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
14
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
15
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
16
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
17
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
18
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Withdrawn
19
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
20
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
21
University of Louisville Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
22
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, United States, 48202
Actively Recruiting
23
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
24
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
25
Dartmouth Hitchcock Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
26
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States, 08103
Actively Recruiting
27
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
28
Morristown Medical Center - Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
29
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
30
Northwell Health, R.J. Zuckerberg Cancer Center
Lake Success, New York, United States, 11042
Actively Recruiting
31
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794
Actively Recruiting
32
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
33
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
34
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
35
The Ohio State University- Martha Morehouse Tower
Columbus, Ohio, United States, 43210
Actively Recruiting
36
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
37
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
38
UPMC
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
39
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
40
West Cancer Center and Research Institute
Germantown, Tennessee, United States, 38138
Actively Recruiting
41
University of Tennessee
Knoxville, Tennessee, United States, 37920
Actively Recruiting
42
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
43
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
44
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
45
Intermountain Health
Murray, Utah, United States, 84107
Actively Recruiting
46
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
47
St. George Regional Hospital
St. George, Utah, United States, 84790
Actively Recruiting
48
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
49
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
50
CHU de Lille
Lille, France, 59000
Actively Recruiting
51
Hopital de La Timone
Marseille, France, 13005
Actively Recruiting
52
CHU Nice
Nice, France, 06200
Actively Recruiting
53
Hôpital Saint Louis - AP-HP
Paris, France, 75010
Actively Recruiting
54
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
Actively Recruiting
55
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
56
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
57
Helios Klinik
Erfurt, Germany, 99089
Actively Recruiting
58
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
59
Universitätsklinikum Medical Center
Hamburg, Germany, 20246
Actively Recruiting
60
Universitätsklinikum Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
61
University of Kiel
Kiel, Germany, 24105
Actively Recruiting
62
Universitatsklinikum Mainz Hautklinik und Poliklinik
Mainz, Germany, 55131
Actively Recruiting
63
Universitätsklinikum of Tübingen
Tübingen, Germany, 72076
Actively Recruiting
64
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
65
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02-781
Actively Recruiting
66
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
67
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
68
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Spain, 30120
Actively Recruiting
69
Clinica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Actively Recruiting
70
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
71
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain, 31008
Actively Recruiting
72
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
73
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
C
Clinical Trials at Replimune
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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