A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC

Official Title

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

Summary:

A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)

Trial Description

Primary Outcome:

  • Pathological Complete Response (pCR) rate, in all randomized participants
  • Event-Free Survival (EFS), in all randomized participants
Secondary Outcome:
  • Overall Survival (OS) in all randomized participants
  • Incidence of Adverse Events (AE) in all treated participants
  • Incidence of Serious Adverse Events (SAE) in all treated participants
  • Incidence of Laboratory abnormalities in all treated participants
  • Incidence of death in all treated participants
  • Pathological Complete Response (pCR) rate, in all randomized participants
  • Event Free Survival (EFS), in all randomized participants

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society