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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Undergo collection of blood, CSF, tissue, stool and urine samples
Given IV
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGStanford Cancer Institute Palo Alto
Palo Alto, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGSmilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Incidence of adverse events
Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.
Time frame: Up to 100 days
Change in disease assessments
Will be summarized at each time point for each disease severity cohort.
Time frame: Baseline up to 100 days
Overall response rate
Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.
Time frame: Up to 100 days
Changes in serum chemokines and circulating immune cells over time
Will be summarized and assessed using generalized linear mixed modeling.
Time frame: Baseline up to 100 days
Gene expression in normal tissues
Will be compared with gene expression in malignant tissues based on two-sample t-test and Wilcoxon rank sum test. False discovery rate, if appropriate, will be used to control for multiple testing.
Time frame: Up to 100 days
Clinical measures of interest
The association between demographic and clinical measures of interest with overall response rate and toxicity will be evaluated using logistic regression modeling to identify potential predictors of outcomes.
Time frame: Up to 100 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale University
New Haven, Connecticut, United States
RECRUITINGMedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGEmory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGNorthwestern University
Chicago, Illinois, United States
ACTIVE_NOT_RECRUITINGUniversity of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
ACTIVE_NOT_RECRUITINGUniversity of Kansas Clinical Research Center
Fairway, Kansas, United States
RECRUITING...and 42 more locations