Trial Title:
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)
NCT ID:
NCT06264180
Condition:
Advanced Melanoma
Conditions: Official terms:
Melanoma
Pembrolizumab
Nivolumab
Relatlimab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Vusolimogene Oderparepvec
Description:
Genetically modified Herpes Simplex Type 1 Virus.
Arm group label:
VO + nivolumab
Other name:
VO
Other name:
RP1
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Anti-PD-1 Monoclonal Antibody
Arm group label:
Physicians Choice
Arm group label:
VO + nivolumab
Other name:
Opdivo
Intervention type:
Biological
Intervention name:
Nivolumab + Relatlimab
Description:
Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3
(LAG-3) blocking antibody.
Arm group label:
Physicians Choice
Other name:
Opdualag
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
A programmed death receptor-1 (PD-1)-blocking antibody indicated.
Arm group label:
Physicians Choice
Other name:
Keytruda
Intervention type:
Drug
Intervention name:
Single-agent chemotherapy
Description:
Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.
Arm group label:
Physicians Choice
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 either as a combination
regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4
therapy.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Male or female who is 12 years of age or older at the time of signed informed
consent.
- Patients with histologically or cytologically confirmed unresectable or metastatic
Stage IIIb through IV/M1a through M1d cutaneous melanoma.
- Confirmed disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4
treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab)
or in sequence.
1. Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8
weeks
2. Patients who in the physician's judgement are not candidates for treatment with
an anti-CTLA-4 antibody are eligible
- Has documented BRAF V600 mutation status. Patients with BRAF mutation should have
received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to
enrollment in the study, unless deemed not clinically indicated at Investigator's
discretion due to concurrent medical condition or prior toxicity.
- Has at least 1 measurable and injectable tumor of ≥1 cm in longest diameter (or
shortest diameter for lymph nodes).
- Has adequate hematologic function.
- Has adequate hepatic function.
- Has adequate renal function.
- Prothrombin time (PT) ≤1.5 × ULN and partial thromboplastin time (PTT) or activated
partial thromboplastin time (aPTT) ≤1.5 × ULN
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 for
patients 18 years and older or a Lansky performance score (PSc) ≥80 for patients 12
to 17 years of age.
- Life expectancy of at least 3 months.
- 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 study treatment.
- Women of childbearing potential must have a negative serum beta-human chorionic
gonadotropin (β-hCG) test within 72 hours before the first dose of study treatment.
Key Exclusion Criteria:
- Primary mucosal or uveal melanoma.
- More than 2 lines of systemic therapy for advanced melanoma.
- Known acute or chronic hepatitis.
- Known human immunodeficiency virus (HIV) infection.
- Active significant herpetic infections or prior complications of HSV-1 infection.
- Had systemic infection requiring IV antibiotics or other serious active infection
requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to
dosing.
- With active significant herpetic infections or prior complications of HSV-1
infection.
- Evidence of spinal cord compression or at high risk of spinal cord compression.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
at time of screening.
- Serum lactate dehydrogenase (LDH) >2 × ULN.
- Major surgery ≤2 weeks prior to starting study drug.
- Prior malignancy active within the previous 3 years, except for locally curable
cancers that have apparently been cured
- History of significant cardiac disease including myocarditis or congestive heart.
- History of life-threatening toxicity related to prior immune.
- Active, known, or suspected autoimmune disease requiring systemic treatment.
- History of (noninfectious) pneumonitis that required steroids or has current
pneumonitis.
- Prior oncolytic virus or other therapy given by intratumoral administration.
- Requires intermittent or chronic use of systemic (oral or IV) antivirals with known
antiherpetic activity (eg, acyclovir).
- Has received a live vaccine within 28 days prior to the first dose of study
treatment.
- Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose,
whichever is shorter.
- Conditions requiring treatment with immunosuppressive doses (>10 mg per day of
prednisone or equivalent) of systemic corticosteroids other than for corticosteroid
replacement therapy within 14 days after enrollment.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Omid Hamid, MD
Email:
Principal Investigator
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Gino In, MD
Email:
Principal Investigator
Facility:
Name:
UCSF Helen Diller Family Comprehensive Cancer Center
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Katy Tsai, MD
Email:
Principal Investigator
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mohammed Milhem, MBBS
Email:
Principal Investigator
Facility:
Name:
University of Louisville Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jason Chesney, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrew L. Pecora, MD
Email:
Principal Investigator
Facility:
Name:
Morristown Medical Center - Atlantic Health System
Address:
City:
Morristown
Zip:
07960
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Eric Whitman, MD
Email:
Principal Investigator
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Georgia Beasley, MD
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Rino Seedor, MD
Email:
Principal Investigator
Facility:
Name:
UPMC
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Yana Najjar, MD
Email:
Principal Investigator
Facility:
Name:
West Cancer Center and Research Institute
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Portnoy, MD, FACP
Email:
Principal Investigator
Facility:
Name:
University of Tennessee
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ardy Davarifar, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Intermountain Health
Address:
City:
Murray
Zip:
84107
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Caroline Nebhan, MD, PhD
Email:
Principal Investigator
Start date:
July 11, 2024
Completion date:
August 31, 2034
Lead sponsor:
Agency:
Replimune Inc.
Agency class:
Industry
Source:
Replimune Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06264180
