Phase
Condition
Solid Tumors
Treatment
DF6002
Nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Advanced/metastatic solid tumors, for which no standard therapy exists or standardtherapy has failed among the following tumor types: melanoma, non-small cell lungcancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric,esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cellcarcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
ECOG performance status of 0 or 1
Clinical or radiological evidence of disease
Adequate hematological, hepatic and renal function
Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessedby Investigator as being at high risk for venous thromboembolism (VTE) or history ofVTE ≥ 6 months from enrollment
Exclusion
Exclusion Criteria:
Concurrent anticancer treatment (with the exception of palliative bone directedradiotherapy), immune therapy, or cytokine therapy (except for erythropoietin),major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy withsteroids or other immunosuppressive agents, or use of any investigational drugwithin 28 days before the start of study treatment
Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directedtherapy, or any drug containing an interleukin-12 (IL-12) moiety
Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin,localized prostate cancer or cervical carcinoma in situ
Rapidly progressive disease
Serious cardiac illness or medical conditions
Known diagnosis of antiphospholipid syndrome or clinically significant hereditarythrombophilia
Other protocol-defined inclusion/exclusion criteria apply
Study Design
Study Description
Connect with a study center
Local Institution - 0023
Box Hill, 3128
AustraliaSite Not Available
Local Institution - 0022
Heidelberg, 3084
AustraliaSite Not Available
Local Institution
Paris, Ile-de-France 75010
FranceActive - Recruiting
Local Institution
Pierre-Bénite, Rhone 69495
FranceSite Not Available
Institut Bergonié
Bordeaux Cedex, 33000
FranceActive - Recruiting
Local Institution - 0026
Bordeaux Cedex, 33000
FranceActive - Recruiting
Hôpital Saint-Louis
Paris, 75010
FranceActive - Recruiting
Local Institution - 0002
Paris, 75010
FranceActive - Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Benite, 69495
FranceActive - Recruiting
Local Institution - 0027
Pierre-Benite, 69495
FranceActive - Recruiting
Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Local Institution - 0001
Villejuif, 94805
FranceActive - Recruiting
Local Institution
Pamplona, Navarre 31008
SpainActive - Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
SpainActive - Recruiting
Local Institution - 0029
Barcelona, 08035
SpainActive - Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, 28027
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Local Institution
Madrid, 28034
SpainActive - Recruiting
Local Institution - 0028
Madrid, 28040
SpainActive - Recruiting
Local Institution - 0030
Madrid, 28034
SpainActive - Recruiting
Local Institution - 0031
Madrid, 28027
SpainActive - Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008
SpainActive - Recruiting
Local Institution - 0025
Pamplona, 31008
SpainActive - Recruiting
Local Institution
Orange, California 92868
United StatesActive - Recruiting
University of California Irvine
Orange, California 92868
United StatesActive - Recruiting
SCRI - HealthOne Denver
Denver, Colorado 80218
United StatesSite Not Available
Local Institution
New Haven, Connecticut 06520
United StatesActive - Recruiting
Yale School of Medicine
New Haven, Connecticut 06520
United StatesActive - Recruiting
Local Institution
Miami, Florida 33136
United StatesActive - Recruiting
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
Augusta University Georgia Cancer Center
Augusta, Georgia 30912-0003
United StatesActive - Recruiting
Local Institution
Augusta, Georgia 30912
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Local Institution
Boston, Massachusetts 02215
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Local Institution
Detroit, Michigan 48202
United StatesActive - Recruiting
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota 55101
United StatesActive - Recruiting
Local Institution
Saint Paul, Minnesota 55101
United StatesActive - Recruiting
Atlantic Health System
Morristown, New Jersey 07960
United StatesActive - Recruiting
Local Institution
Bronx, New York 10461
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
Local Institution
Buffalo, New York 14203
United StatesActive - Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United StatesSite Not Available
Local Institution
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Local Institution
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Local Institution
Providence, Rhode Island 02903
United StatesActive - Recruiting
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesActive - Recruiting
Local Institution
Nashville, Tennessee 37205
United StatesActive - Recruiting
SCRI - Tennessee Oncology - Saint Thomas West Clinic
Nashville, Tennessee 37205
United StatesActive - Recruiting
Local Institution
Houston, Texas 77030
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Huntsman Cancer Institute and Hospital
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Local Institution
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Local Institution
Fairfax, Virginia 22031
United StatesActive - Recruiting
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia 22031
United StatesActive - Recruiting
Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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