A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
National Cancer Institute (NCI)
Summary
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). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.
Description
PRIMARY OBJECTIVES: 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. II. To assess the overall safety, and toxicities associated with the use of the anti-p…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1/PD-L1 inhibitors are FDA-approved for the trea…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood, CSF, tissue, stool and urine samples
- DrugCabozantinib
Given PO
- DrugFluoropyrimidine
Given fluoropyrimidine
- BiologicalIpilimumab
Given IV
- BiologicalNivolumab
Given IV
- DrugPlatinum Compound
Given platinum containing chemotherapy
- DrugPlatinum Doublet
Given platinum doublet
Locations (52)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Stanford Cancer Institute Palo AltoPalo Alto, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- Smilow Cancer Center/Yale-New Haven HospitalNew Haven, Connecticut
- Yale UniversityNew Haven, Connecticut
- MedStar Georgetown University HospitalWashington D.C., District of Columbia