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Research summary · AI summary · not yet reviewedSubjects not reportedPhase 1Trial registry
Assessment of Nivolumab in Autoimmune Disorders including Multiple Sclerosis (MS)
A Phase 1 trial aims to evaluate the safety and toxicities of nivolumab in patients with autoimmune disorders, including MS. It also seeks to assess its effectiveness in terms of response rates and survival metrics. However, no results are currently available, and the planned endpoints do not indicate efficacy.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
This research is crucial as it explores a potential treatment's safety profile for autoimmune diseases. Understanding the toxicities could inform future therapies, particularly for conditions like MS.
What this does not prove
There are no posted results available, and the planned enrolment does not equate to actual findings or demonstrate efficacy.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- 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
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (7)
study phase"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).
study designTo 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.
intervention"description": "Patients may receive single agent nivolumab IV over 30 minutes every 4 weeks for up to 2 years for patients with metastatic indications, for up to 1 year for adjuvant indications or for up to 3 months after surgery for neoadjuvant indications in the absence of disease progression or unacceptable toxicity.
follow upWill be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.
findingsTo 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.
limitationsPlanned enrolment and endpoints are not findings.
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