Atezolizumab and BCG in High Risk BCG naïve Non-muscle Invasive Bladder Cancer (NMIBC) Patients (BladderGATE)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 3, 2020

Primary Completion Date

June 30, 2024

Study Completion Date

September 30, 2024

Conditions
Invasive Bladder Cancer
Interventions
DRUG

Atezolizumab

1200 mg IV q3w until recurrence of disease, disease progression (e.g., muscle-invasive or metastatic UBC), symptomatic deterioration (i.e., uncontrollable pain secondary to disease or unmanageable ascites, etc.) attributed to disease progression as determined by the investigator, Intolerable toxicity related to atezolizumab, including development of an immune-mediated adverse event determined by the investigator to be unacceptable given the individual patient's potential response to therapy and severity of the event, any medical condition that may jeopardize the patient's safety if he or she continues on study treatment, use of another non-protocol anti-cancer therapy or pregnancy.

DRUG

BCG

1 or 1/2 instillation per week until recurrence of disease, disease progression (e.g., muscle-invasive or metastatic UBC), symptomatic deterioration (i.e., uncontrollable pain secondary to disease or unmanageable ascites, etc.) attributed to disease progression as determined by the investigator, Intolerable toxicity related to atezolizumab, including development of an immune-mediated adverse event determined by the investigator to be unacceptable given the individual patient's potential response to therapy and severity of the event, any medical condition that may jeopardize the patient's safety if he or she continues on study treatment, use of another non-protocol anti-cancer therapy or pregnancy.

Trial Locations (1)

Unknown

Hospital 12 de Octubre, Madrid

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Apices Soluciones S.L.

INDUSTRY

lead

Fundacion Oncosur

NETWORK

NCT04134000 - Atezolizumab and BCG in High Risk BCG naïve Non-muscle Invasive Bladder Cancer (NMIBC) Patients (BladderGATE) | Biotech Hunter | Biotech Hunter