Human Trial of Nivolumab for Autoimmune Disorders including MS
This Phase Ib trial explores the safety and adverse effects of nivolumab in patients with various autoimmune disorders, including multiple sclerosis. The study design is interventional, involving about 300 estimated participants. It aims to evaluate the side effects and efficacy of nivolumab alone and with other treatments.
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Why it matters
Understanding the safety profile of nivolumab could be important for its potential application in managing autoimmune disorders like MS, although no results are currently available.
What this does not prove
There are no posted results for this trial, and the planned enrolment and endpoints are not indicative of findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 300 · Estimated
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Other
Original sources
Supporting passages (12)
study phasePHASE1
study designINTERVENTIONAL
subjectsTo 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.\n\nII.
sample size300
sample size basisESTIMATED
regulatory approvalTo assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab and other Food and Drug Administration (FDA)-approved combinations for given oncologic indications in patients with varying severity of DM/SSc, RA, SLE, IBD (ulcerative colitis \\[UC\\] and Crohn's disease \\[CD\\]), MS, Sjogren's syndrome \\[SjS\\], psoriasis (PsO)/psoriatic arthritis (PsA), and other autoimmune diseases.\n\nSECONDARY OBJECTIVES:\n\nI.
regulatory approval detailsTo assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab and other Food and Drug Administration (FDA)-approved combinations for given oncologic indications in patients with varying severity of DM/SSc, RA, SLE, IBD (ulcerative colitis \\[UC\\] and Crohn's disease \\[CD\\]), MS, Sjogren's syndrome \\[SjS\\], psoriasis (PsO)/psoriatic arthritis (PsA), and other autoimmune diseases.\n\nSECONDARY OBJECTIVES:\n\nI.
research categoriesOther
interventionNivolumab
primary endpointIncidence of adverse events
findings"briefSummary": "This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable).
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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