NCT02626130

Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer

A Pilot Study of Tremelimumab With or Without Tissue Cryoablation in Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot clinical trial studies the side effects of tremelimumab with or without tissue cryoablation in treating patients with kidney cancer that has spread to other places in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell). Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in treating patients with kidney cancer.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate safety of tremelimumab alone and in combination with cryoablation in patients with metastatic renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. To explore the longitudinal values for immunological variables (including cluster of differentiation \[CD\]4+ ICOS+ T cells; effector to regulatory T cell ratio; absolute lymphocyte count) following treatment with tremelimumab in patients with metastatic RCC, and evaluate difference between combination cryoablation and tremelimumab in comparison to tremelimumab alone. II. To determine the objective response rate and progression-free survival of patients treated with tremelimumab with or without cryoablation. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive tremelimumab intravenously (IV) over 60 minutes at weeks 1 and 5. Within 4-6 weeks later, patients undergo surgery or biopsy. After surgery or biopsy, patients receive tremelimumab IV every 4 weeks (Q4W) for 3 doses, and then every 12 weeks (Q12W) in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo cryoablation and receive tremelimumab IV over 60 minutes at weeks 1 (2-6 days after cryoablation) and 5. Within 4-6 weeks later, patients undergo surgery or biopsy. After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then Q12W in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30, 60, and 90 days, and then every 6 months.

Conditions

• Clear Cell Renal Cell Carcinoma
• Metastatic Renal Cell Cancer
• Stage IV Renal Cell Cancer AJCC v7

Interventions

Type	Name	Description
PROCEDURE	Cryosurgery	Undergo cryoablation
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery
BIOLOGICAL	Tremelimumab	Given IV

Timeline

• Start date: 2016-03-30
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2015-12-10
• Last updated: 2022-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study