A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab 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 nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Capital Federal, Buenos Aires 1280, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1425, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires 1426, Argentina
CABA, 1199, Argentina
Wuhan, Hebei 430030, China
Toyoake Shi, Aichi-ken 4701192, Japan
Hirosaki-shi, Aomori 0368563, Japan
Shiwa-gun, Iwate 0283695, Japan
Osakasayama-shi, Osaka 5898511, Japan
Suita-shi, Osaka 565-0871, Japan
Adachi-ku, Tokyo 1230872, Japan
Bunkyo-ku, Tokyo 113-8510, Japan
Bunkyo-ku, Tokyo 1138603, Japan
Shinjuku-ku, Tokyo 1608582, Japan
Ube-shi, Yamaguchi 7558505, Japan