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

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.

Conditions

• Autoimmune Disease
• Crohn Disease
• Dermatomyositis
• Hematopoietic and Lymphoid Cell Neoplasm
• Inflammatory Bowel Disease
• Malignant Solid Neoplasm
• Multiple Sclerosis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Sjogren Syndrome
• Systemic Lupus Erythematosus
• Systemic Scleroderma
• Ulcerative Colitis

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood, CSF, tissue, stool and urine samples

DRUG

Cabozantinib

Given PO

DRUG

Fluoropyrimidine

Given fluoropyrimidine

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Platinum Compound

Given platinum containing chemotherapy

DRUG

Platinum Doublet

Given platinum doublet

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Hussein A Tawbi · University of Texas MD Anderson Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-16

Primary Completion

2028-03-30

Completion

2028-03-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations