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Trial Summary

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.

Acronym:

SunRISe-2

ACTRN/NCT /ethics:

NCT04658862

Scientific title:

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Sponsor / Cooperative group:

Janssen Research & Development, LLC

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 Date2020-12-07
Anticipated End Date2026-12-26

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorDr Sina Vatandoust
Recruitment StatusRecruiting