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Brief description/objective

The current standard treatment for early stage (l-lll) renal
cell cancer (RCC) is surgery. While the prognosis of stage
I tumors is excellent, stage II and particularly stage III
have a high risk of relapse and represent a high unmet
medical need. The clinical activity of nivolumab and
nivolumab plus ipilimumab observed to date in advanced
RCC include 1 positive Phase 3 study demonstrating prolonged
survival with nivolumab monotherapy compared to
everolimus in metastatic RCC and significant improvement
in OS with nivolumab plus ipilimumab compared
with sunitinib in the Checkmate 214 study. Based on the
Checkmate 214 study results, the combination of
nivolumab and ipilimumab is approved by the US Food
and Drug Administration (FDA) for the treatment of intermediate-
and poor-risk, previously untreated patients with
advanced RCC, and it is incorporated into the European
Association of Urology guidelines. These results suggests
the potential for improved clinical outcomes also in the adjuvant
setting. In 2016, nivolumab was approved in the
Switzerland for the treatment of metastatic RCC in patients
who previously received anti-angiogenic therapy.
The study CA209914 aims to explore the role of the
nivolumab and ipilimumab combination compared to placebo
and the role of nivolumab monotherapy compared to
placebo post-surgery in added efficacy and safety in preventing
disease recurrence and the impact on survival. If
the safety profile is acceptable and nivolumab monotherapy
or nivolumab combined with ipilimumab is shown to
improve DFS, this study would support the approval of
nivolumab or nivolumab combined with ipilimumab in
treatment-naive advanced RCC patients post-surgery.