Phase Ib Study Evaluating Nivolumab Alone or With Other Treatments in Patients with Autoimmune Disorders and Advanced or Metastatic Cancer

What this Trial Is About

Researchers are evaluating the side effects and effectiveness of nivolumab alone and in combination with other treatments for patients who have autoimmune disorders alongside advanced, metastatic, or unresectable cancers. This phase Ib trial focuses on various autoimmune diseases such as dermatomyositis, systemic sclerosis, rheumatoid arthritis, lupus, inflammatory bowel diseases, multiple sclerosis, Sjogrens syndrome, psoriasis, and psoriatic arthritis, aiming to understand how immunotherapy can help the immune system attack cancer cells. Participants are assigned to one of eleven treatment groups, receiving intravenous nivolumab alone or combined with ipilimumab, cabozantinib, platinum-containing chemotherapy, or fluoropyrimidine. Treatment schedules vary by group, with nivolumab administered every 2 to 4 weeks for up to two years in some cases, or shorter durations depending on the treatment setting metastatic, adjuvant, or neoadjuvant. Combination therapies have specified dosing intervals and cycles. Throughout the trial, patients provide blood, cerebrospinal fluid, tissue, stool, and urine samples for analysis. During the study, participants undergo regular evaluations including scans, blood tests, and disease assessments to monitor safety, toxicity, tumor response, and autoimmune disease severity. After completing treatment, patients without disease progression are followed for 100 days, while those with progression are monitored every 12 weeks for up to five years. The primary outcomes include measuring adverse events, changes in disease status, overall response rates, and biological markers related to treatment effects.

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO