Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04904302
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial investigates the effect of sitravatinib and nivolumab in treating patients with clear cell renal cell cancer that has spread to other places in the body (metastatic/advanced). 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 kill more tumor cells.

Key Dates

Start date
May 3, 2022
Status verified
Mar 2026
Primary completion
Mar 11, 2026
Completion
Mar 11, 2026

Study Design

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

Arms

  • Experimental: Treatment (sitravatinib, nivolumab)
    Patients receive sitravatinib PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective response rate [ Time Frame: At 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana University Hospital / IU Simon Cancer CenterIndianapolisIndiana46202-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Indianapolis, IN

By research site
Indiana University Hospital / IU Simon Cancer Center· Indianapolis, INM D Anderson Cancer Center· Houston, TX

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