Study of NIVOLUMAB/IPILIMUMAB Maintenance in Unresectable Locally Advanced or Metastatic Urothelial Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

July 6, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

Conditions
Urothelial Cancer
Interventions
DRUG

Nivolumab

Nivolumab at 1 mg/kg by intravenous (IV) infusion on D1 of each cycle. Nivolumab at a fixed dose of 480 mg by intravenous (IV) infusion on D1 of each cycle. The maximum duration of treatment with nivolumab will be 2 years, and patients will discontinue treatment at any time in case of unacceptable toxicity, disease progression (PD), investigator ́s decision, patient's consent withdrawal or death by any cause, whichever occurs first.

DRUG

Ipilimumab

Ipilimumab at 3 mg/kg by intravenous (IV) infusion on D1 of each cycle.

Trial Locations (12)

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

21005

Hospital Universitario Juan Ramón Jiménez, Huelva

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

33011

Hospital Universitario Central de Asturias, Oviedo

37007

Complejo asistencial universitario de Salamanca, Salamanca

41009

Hospital Universitario Virgen de la Macarena, Seville

45004

Hospital Universitario de Toledo, Toledo

46600

Hospital Universitario de la Ribera, Alzira

50009

Hospital Clínico Universitario de Zaragoza, Zaragoza

07120

Hospital Universitario Son Espases, Palma de Mallorca

08036

Hospital Clínic de Barcelona, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Spanish Oncology Genito-Urinary Group

OTHER

NCT05219435 - Study of NIVOLUMAB/IPILIMUMAB Maintenance in Unresectable Locally Advanced or Metastatic Urothelial Cancer | Biotech Hunter | Biotech Hunter