Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03816345|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Autoimmune Disease Crohn Disease Dermatomyositis Hematopoietic and Lymphoid Cell Neoplasm Inflammatory Bowel Disease Metastatic Malignant Solid Neoplasm Multiple Sclerosis Rheumatoid Arthritis Sjogren Syndrome Systemic Lupus Erythematosus Systemic Scleroderma Ulcerative Colitis Unresectable Malignant Solid Neoplasm||Biological: Nivolumab||Phase 1|
I. To assess the overall safety, including the incidence of dose-limiting toxicity (DLT), and other 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], and other autoimmune diseases.
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, 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.
V. To perform molecular profiling assays on malignant and normal tissues, including, but not limited to, ribonucleic acid (RNA) sequencing, in order to: identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned, and identify resistance mechanisms using genomic deoxyribonucleic acid (DNA)- and ribonucleic acid (RNA)-based assessment platforms.
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.
After completion of study treatment, patients are followed up for 100 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)|
|Actual Study Start Date :||April 4, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Experimental: Treatment (nivolumab)
Patients receive nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Incidence of adverse events [ Time Frame: Up to 100 days ]Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.
- Change in disease assessments [ Time Frame: Baseline up to 100 days ]Will be summarized at each time point for each disease severity cohort.
- Overall response rate [ Time Frame: Up to 100 days ]Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.
- Changes in serum chemokines and circulating immune cells over time [ Time Frame: Baseline up to 100 days ]Will be summarized and assessed using generalized linear mixed modeling.
- Gene expression in normal tissues [ Time Frame: Up to 100 days ]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.
- Clinical measures of interest [ Time Frame: Up to 100 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816345
|Principal Investigator:||Hussein A Tawbi||University of Texas MD Anderson Cancer Center LAO|