NCT03525925

Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors

Pilot Study Testing the Effects of BTK Inhibitor Ibrutinib on Levels and Function of Myeloid Derived Suppressor Cells and Other Immune Subsets in Patients With Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase I trial studies how well ibrutinib and nivolumab work in treating participants with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib and nivolumab may work better in treating participants with solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the effect of the ibrutinib therapy on circulating levels of myeloid derived suppressor cells MDSC. SECONDARY OBJECTIVES: I. Assess safety of the study combination in study subjects. EXPLORATORY OBJECTIVES: I. Evaluate the effect of the ibrutinib/nivolumab therapy on circulating levels of MDSC. II. Evaluate the effect of the ibrutinib and ibrutinib/nivolumab therapy on the immunosuppressive function of circulating MDSC by measuring their ability to inhibit T cell proliferation and natural killer cell mediated antibody dependent cell cytotoxicity. III. Study the effect of ibrutinib and ibrutinib/nivolumab therapy on levels of circulating innate and adaptive immune cells such as natural killer cell and T lymphocyte subsets. IV. Study circulating MDSC levels at the time of disease progression. V. Evaluate in a preliminary fashion the effect of the regimen on progression-free survival. OUTLINE: Participants receive ibrutinib orally (PO) daily for 15 days. After 7 days receiving ibrutinib, participants receive nivolumab intravenously (IV) over 60 minutes on days 1 and 15. Courses with nivolumab repeat every 28 days in the absence of disease progression or unaccepted toxicity. After completion of study treatment, participants are followed up every 3 months.

Conditions

• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2018-07-18
• Primary completion: 2020-02-20
• Completion: 2022-07-31
• First posted: 2018-05-16
• Last updated: 2024-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study