A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/17/2019
Start Date:	July 5, 2017
End Date:	July 7, 2023
Contact:	Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:	Clinical.Trials@bms.com
Phone:	please email:

A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to determine whether the combination of nivolumab and ipilimumab
is safe and effective for delaying or preventing recurrence of cancer in patients who have
experienced the partial or entire removal of a kidney

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

- Kidney tumor has been completely resected 4 to 12 weeks prior to randomization

- Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G
any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0

- Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including
participants with sarcomatoid features

Exclusion Criteria:

- Participants with an active known or suspected autoimmune disease

- Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

- Any severe or serious, acute or chronic medical or psychiatric condition, or
laboratory abnormality that may increase the risk associated with study participation

- Participants with a condition requiring systemic treatment with corticosteroids

Other protocol defined inclusion/exclusion criteria could apply

We found this trial at

sites

Inova Schar Cancer Institute

Fairfax, Virginia 22031

Phone: 703-970-6488

from

Fairfax, VA