BMS CA17-078: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle Invasive Bladder Cancer
Laufzeit: 01.01.2019 - 31.12.2025
Kurzfassung
To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvante alone in all randomize participants.
To compare EFS of neoadjuvant nivolumab/BMS-986205 +
GC followed by continued nivolumab/BMS-986205 after
RC versus SOC GC followed by RC in all randomized
participants.
Sekundäre Endpunkte/Zielsetzungen:
To compare overall survival (OS) of neoadjuvant nivolumab/BMS-986205 + GC or nivolumab + GC followed by continued IO therapy after RC versus neoadjuvant SOC GC followed by RC...To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvante alone in all randomize participants.
To compare EFS of neoadjuvant nivolumab/BMS-986205 +
GC followed by continued nivolumab/BMS-986205 after
RC versus SOC GC followed by RC in all randomized
participants.
Sekundäre Endpunkte/Zielsetzungen:
To compare overall survival (OS) of neoadjuvant nivolumab/BMS-986205 + GC or nivolumab + GC followed by continued IO therapy after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm C vs Arm A and Arm B vs Arm A).
To describe the safety and tolerability of nivolumab and
nivolumab/BMS-986205 in combination with GC
chemotherapy.
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