Study Comparing Nivolumab and Ipilimumab Combination to Nivolumab Alone in Advanced Kidney Cancer

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT03873402

This clinical trial is evaluating whether combining two immunotherapy drugs, nivolumab and ipilimumab, is more effective and safe compared to using nivolumab alone for treating advanced kidney cancer that has spread and has not been treated before.

Patient Parameters

Program Overview

The aim of this study is to determine if using a combination of two immunotherapy drugs, nivolumab and ipilimumab, can better treat advanced kidney cancer compared to using nivolumab by itself. This study focuses on patients whose kidney cancer has spread and who have not received any prior treatment for their condition.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of kidney cancer with a clear cell component, which may include certain features like sarcomatoid characteristics.
  • Have advanced kidney cancer that cannot be cured with surgery or radiation, or cancer that has spread to other parts of the body.
  • Have at least one tumor that can be measured using a CT or MRI scan.
  • Have not received any previous treatment for kidney cancer.
  • Be classified as intermediate or poor risk according to specific medical criteria for kidney cancer.

Exclusion Criteria

  • Have any active cancer that has spread to the brain or central nervous system.
  • Have an active or suspected autoimmune disease.
  • Have previously received treatments targeting specific immune system pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies.
  • Other specific criteria may apply as defined by the study protocol.

Locations

FACILITYZIPCITYSTATE
Local Institution - 001320007Washington D.C.District of Columbia
Local Institution - 005330607AthensGeorgia
Local Institution - 006602114BostonMassachusetts
Local Institution - 008802114BostonMassachusetts
Local Institution - 008602215BostonMassachusetts
The Reading Hosp Med Ctr Reg Cancer Ctr19611West ReadingPennsylvania
Local Institution - 008429414CharlestonSouth Carolina

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