Spots Global Cancer Trial Database for Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
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Trial Identification
Brief Title: Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
Official Title: A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Study ID: NCT03816345
Study Description
Brief Summary: This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description: PRIMARY OBJECTIVE: I. To assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of dermatomyositis (DM)/systemic sclerosis (SSc), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD) (ulcerative colitis \[UC\] and Crohn's disease \[CD\]), multiple sclerosis (MS), Sjogren's syndrome \[SjS\], Psoriasis (PsO)/Psoriatic Arthritis (PsA), and other autoimmune diseases. SECONDARY OBJECTIVES: I. To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs), progression-free survival (PFS), and overall survival (OS) in patients with cancer and DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, PsO/PsA, and other autoimmune diseases. II. To observe and record anti-tumor activity. III. To propose dosing recommendations for anti-PD-1 antibodies based on the severity of the autoimmune disorder. IV. To evaluate the impact of nivolumab on the disease severity indices for: DM/SSc, RA, SLE, IBD: UC and CD, not specified (NS), MS, SjS, PsO/PsA. V. To identify biomarkers of response and toxicity. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, cerebrospinal fluid (CSF), tissue, stool, and urine samples throughout the trial. After completion of study treatment, patients are followed up for 100 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
HaysMed, Hays, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Olathe Health Cancer Center, Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States
Ascension Via Christi - Pittsburg, Pittsburg, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus, Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
University Health Truman Medical Center, Kansas City, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
NYU Langone Hospital - Long Island, Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
UT Southwestern Simmons Cancer Center - RedBird, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Hussein A Tawbi
Affiliation: University of Texas MD Anderson Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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