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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03015740
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Sitravatinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Apr 23, 2017
Status verified
Oct 2024
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (sitravatinib, nivolumab)
    Patients receive sitravatinib PO QD on days 1-14 and receive nivolumab 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 DLTs related to nivolumab, may then receive nivolumab every 4 weeks.

Primary Outcome Measure

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: from enrollment up to 12 weeks for each dosing group ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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