Eligibility
Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.
Show 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.
Sites (73)
Sort by distance to:
CHU Nice
Nice, 06200, France
No email / No phone
Status: Recruiting
CHU de Lille
Lille, 59000, France
No email / No phone
Status: Recruiting
Hopital de La Timone
Marseille, 13005, France
No email / No phone
Status: Recruiting
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
No email / No phone
Status: Recruiting
Hôpital Saint Louis - AP-HP
Paris, 75010, France
No email / No phone
Status: Recruiting
Institut Gustave Roussy
Villejuif, 94800, France
No email / No phone
Status: Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
No email / No phone
Status: Recruiting
Helios Klinik
Erfurt, 99089, Germany
No email / No phone
Status: Recruiting
Universitatsklinikum Mainz Hautklinik und Poliklinik
Mainz, 55131, Germany
No email / No phone
Status: Recruiting
University of Kiel
Kiel, 24105, Germany
No email / No phone
Status: Recruiting
Universitätsklinikum Essen
Essen, 45147, Germany
No email / No phone
Status: Recruiting
Universitätsklinikum Hospital Heidelberg
Heidelberg, 69120, Germany
No email / No phone
Status: Recruiting
Universitätsklinikum Medical Center
Hamburg, 20246, Germany
No email / No phone
Status: Recruiting
Universitätsklinikum of Tübingen
Tübingen, 72076, Germany
No email / No phone
Status: Recruiting
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02-781, Poland
No email / No phone
Status: Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
No email / No phone
Status: Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, 28027, Spain
No email / No phone
Status: Recruiting
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008, Spain
No email / No phone
Status: Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
No email / No phone
Status: Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
No email / No phone
Status: Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
No email / No phone
Status: Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
No email / No phone
Status: Recruiting
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA, United Kingdom
No email / No phone
Status: Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
No email / No phone
Status: Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
No email / No phone
Status: Recruiting
San Francisco Oncology Associates
San Francisco, California, 94115, United States
No email / No phone
Status: Recruiting
Stanford Cancer Institute
Palo Alto, California, 94304, United States
No email / No phone
Status: Recruiting
Sutter Medical Group
Sacramento, California, 95816, United States
No email / No phone
Status: Recruiting
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
No email / No phone
Status: Recruiting
UC Irvine Health, Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
No email / No phone
Status: Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037, United States
No email / No phone
Status: Recruiting
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095, United States
No email / No phone
Status: Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
No email / No phone
Status: Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
No email / No phone
Status: Recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113, United States
No email / No phone
Status: Recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
No email / No phone
Status: Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
No email / No phone
Status: Recruiting
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
No email / No phone
Status: Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612, United States
No email / No phone
Status: Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
No email / No phone
Status: Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
No email / No phone
Status: Recruiting
University of Iowa
Iowa City, Iowa, 52242, United States
No email / No phone
Status: Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
No email / No phone
Status: Recruiting
University of Louisville Brown Cancer Center
Louisville, Kentucky, 40202, United States
No email / No phone
Status: Recruiting
Corewell Health
Grand Rapids, Michigan, 49503, United States
No email / No phone
Status: Recruiting
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202, United States
No email / No phone
Status: Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455, United States
No email / No phone
Status: Recruiting
Dartmouth Hitchcock Cancer Center
Lebanon, New Hampshire, 03756, United States
No email / No phone
Status: Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
No email / No phone
Status: Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
No email / No phone
Status: Recruiting
Morristown Medical Center - Atlantic Health System
Morristown, New Jersey, 07960, United States
No email / No phone
Status: Recruiting
Montefiore Medical Center
The Bronx, New York, 10461, United States
No email / No phone
Status: Recruiting
Northwell Health, R.J. Zuckerberg Cancer Center
Lake Success, New York, 11042, United States
No email / No phone
Status: Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
No email / No phone
Status: Recruiting
Stony Brook University Cancer Center
Stony Brook, New York, 11794, United States
No email / No phone
Status: Recruiting
Duke Cancer Center
Durham, North Carolina, 27710, United States
No email / No phone
Status: Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
No email / No phone
Status: Recruiting
The Ohio State University- Martha Morehouse Tower
Columbus, Ohio, 43210, United States
No email / No phone
Status: Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
No email / No phone
Status: Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
No email / No phone
Status: Recruiting
UPMC
Pittsburgh, Pennsylvania, 15232, United States
No email / No phone
Status: Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
No email / No phone
Status: Recruiting
University of Tennessee
Knoxville, Tennessee, 37920, United States
No email / No phone
Status: Recruiting
West Cancer Center and Research Institute
Germantown, Tennessee, 38138, United States
No email / No phone
Status: Recruiting
Texas Oncology
Dallas, Texas, 75246, United States
No email / No phone
Status: Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
No email / No phone
Status: Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
No email / No phone
Status: Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
No email / No phone
Status: Recruiting
Intermountain Health
Murray, Utah, 84107, United States
No email / No phone
Status: Recruiting
St. George Regional Hospital
St. George, Utah, 84790, United States
No email / No phone
Status: Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
No email / No phone
Status: Recruiting
West Virginia University
Morgantown, West Virginia, 26506, United States
No email / No phone
Status: Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
No email / No phone
Status: Withdrawn
