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

Full Name

MSK 17-411 (CA209-914): 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

Description

Experimental: Module A: Nivolumab + Ipilimumab

Interventions:

Biological: Nivolumab

Biological: Ipilimumab

Placebo Comparator: Module B: Placebo

Intervention: Drug: Placebo

Eligibility

Inclusion Criteria

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

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

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

Doctor(s) Running This Study

Accepting New Patients

Specialties
Hematology/Medical Oncology
Area of focus
Melanoma
Kidney cancer (renal cancer)
Sarcoma
LVHN Affiliates
Lehigh Valley Cancer Institute
Locations

1240 S Cedar Crest Blvd
Suite 401
Allentown, PA 18103-6218
United States

181 East Brown Street
East Stroudsburg, PA 18301-3004
United States

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