Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

December 23, 2020

Primary Completion Date

February 2, 2024

Study Completion Date

February 2, 2024

Conditions
Locally Advanced or Metastatic Urothelial Carcinoma
Interventions
DRUG

Atezolizumab 1200 mg/m2

Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.

DRUG

Gemcitabine 1000 mg/m2

Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.

DRUG

Cisplatin 70 mg/m2

Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.

Trial Locations (12)

12002

Hospital Provincial de Castellón, Castellon

28040

Hospital Clínico Universitario San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

33011

Hospital Universitario Central de Asturias, Oviedo

35016

Complejo Hospitalario Universitario Insular Marterno Infantil, Las Palmas de Gran Canaria

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08908

ICO Hospitalet- Hospital Duran i Reynals, Barcelona

Unknown

Hospital Universitario de Jaén, Jaén

Complejo Hospitalario Universitario Ourense, Ourense

Hospital Virgen de la Salud, Toledo

07198

Hospital Son Llàtzer, Palma de Mallorca

All Listed Sponsors
collaborator

Roche Farma, S.A

INDUSTRY

lead

Spanish Oncology Genito-Urinary Group

OTHER

NCT04602078 - Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma | Biotech Hunter | Biotech Hunter