Sitravatinib and Nivolumab in Treating Patients With Advanced or Metastatic Kidney Cancer

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title: Phase I/II Trial of MGCD516 Combined With Nivolumab in Patients With Advanced Clear Cell Renal Cell Cancer That Progressed on Prior VEGF-Targeted Therapy

Status Completed

Clinical Trial Summary

This phase I/II trial studies the side effects of sitravatinib and how well it works with nivolumab in treating patients with kidney cancer that has spread to other places in the body. Sitravatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sitravatinib and nivolumab may work better in treating patients with kidney cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the toxicities (defined as a grade 3 or 4 National Cancer Institute [NCI] non-hematologic or hematologic adverse event, within 12 weeks from treatment initiation), and efficacy (defined as achieving complete remission, partial remission, or stable disease within 6 weeks) of sitravatinib (MGCD516) when administered orally (PO) daily in combination with standard dose nivolumab 240 mg/kg every 2 weeks.

SECONDARY OBJECTIVES:

I. To estimate the overall survival (OS), progression-free survival (PFS) times, objective response rates (ORR), and quality of life (QOL) of patients with advanced clear cell renal cell cancer (RCC) treated with the combination of MGCD516 and nivolumab.

II. Evaluate potential biomarkers for patient stratification and treatment response, including genetic analysis, serum cytokines and chemokines, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity.

OUTLINE:

Patients receive sitravatinib PO once daily (QD) on days 1-14 and receive nivolumab intravenously (IV) over 60 minutes on day 1 starting cycle 2. Cycles repeat every 14 days for cycles 1-6 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients who receive at least 6 infusions of nivolumab with no dose limiting toxicities (DLTs) related to nivolumab, may then receive nivolumab every 4 weeks.

After completion of study treatment, patients are followed up at 30 days and then every 3 months. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Kidney Neoplasms
• Metastatic Kidney Carcinoma
• Stage III Renal Cell Cancer AJCC v7
• Stage IV Renal Cell Cancer AJCC v7

• NCT number: NCT03015740
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 23, 2017
• Completion date: September 6, 2022