NCT02899078

Ibrutinib and Nivolumab in Treating Patients With Previously-Treated Metastatic Kidney Cancer

Phase Ib/II Trial of Ibrutinib Plus Nivolumab in Patients With Previously-Treated Metastatic Renal Cell Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib/II trial studies how well ibrutinib and nivolumab work in treating patients with previously-treated kidney cancer that has spread to other parts of 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 patients with metastatic kidney cancer.

Detailed description

PRIMARY OBJECTIVE: To assess in a preliminary fashion the feasibility and efficacy of ibrutinib in combination with nivolumab in patients with previously-treated metastatic renal cell cancer (mRCC). SECONDARY OBJECTIVE: To evaluate the safety of the combination of ibrutinib and nivolumab in patients with previously treated mRCC.

Conditions

• Metastatic Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
DRUG	Nivolumab	Given IV

Timeline

• Start date: 2016-11-15
• Primary completion: 2020-08-05
• Completion: 2021-02-24
• First posted: 2016-09-14
• Last updated: 2025-05-18
• Results posted: 2022-02-10

Locations

1 site across 1 country: United States