Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 14, 2022

Primary Completion Date

September 5, 2025

Study Completion Date

September 5, 2027

Conditions
Urothelial CarcinomaBladder Cancer
Interventions
DRUG

Ipilimumab + nivolumab

"Induction with immune checkpoint blockade: ipilimumab 3mg/kg on day 1, pilimumab 3mg/kg plus nivolumab 1mg/kg on day 22, and nivolumab 3mg/kg on day 43~Response evaluation after the last cycle of checkpoint inhibition.~Chemoradiation will start 10-12 weeks after start of checkpoint inhibition according to the following scheme:~* Mitoycine C (12mg/m2) on the first day of radiotherapy, followed by either 5-fluorouracil intravenously (500mg/m2) five days a week during week one and four of radiation, or oral capecitabin (2x825mg/m2) every day during the radiation period~* Radiation with a preference for a four-week schedule, in which 55 Gy will be administered using intensity modulated radiation therapy"

Trial Locations (3)

1066CX

Antoni van Leeuwenhoek ziekenhuis, Amsterdam

Unknown

Erasmus Medical Center, Rotterdam

Universitair Medisch Centrum Utrecht, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

The Netherlands Cancer Institute

OTHER

NCT05200988 - Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC | Biotech Hunter | Biotech Hunter