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Trial Summary

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC)

Acronym:

ENERGIZE

ACTRN/NCT /ethics:

NCT03661320

Scientific title:

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Sponsor / Cooperative group:

Bristol-Myers Squibb

Trial & Patient Characteristics

Cancer TypeBladder
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2018-11-06
Anticipated End Date2024-01-15

Participating Hospitals

HospitalCalvary North Adelaide Hospital
Clinical Trial CoordinatorJulie Rowe
Emailjulie.rowe@calvarycare.org.au
Phone08 8239 9536
Principal InvestigatorDr Rohit Joshi
Recruitment StatusRecruiting