Trials Sponsors Conditions Drugs Pricing

Conditions

Muscle-invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

The primary endpoint will be the pathological complete response defined as a response of grade 5 according to Miller and Payne criteria (Appendix 5) after the end of the treatment.

Interventions

Tecentriq 1 200 mg concentrate for solution for infusionType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Tecentriq 1 200 mg concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Tecentriq 1 200 mg concentrate for solution for infusion
Named ingredient: atezolizumab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must be 18 years of age or older.
Patients have histologically-confirmed diagnosis of muscle-invasive urothelial carcinoma of the bladder, in clinical stages T2-4a N0 M0, who are not candidates for radical cystectomy by medical reasons, refusal or patient’s choice.

Sponsors & Collaborators

Grupo Espanol De Oncologia Genitourinaria-Socug
Otherlead

Study Sites (10)

Hospital Arnau De Vilanova De Valencia

Valencia, 46015, Spain

José García+34961976177 joseche812@hotmail.com

Parc Tauli Hospital Universitari

Sabadell, 08208, Spain

Teresa Bonfill+34937240084 tbonfill@tauli.cat

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

Elena Sevillano+34917567984

Central Study Contacts

Isabel Grau

+34610286915 trialmanager@sogug.es

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 17, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-514604-14-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:13:17 UTC

Documents

Protocol_redacted

You may not qualify if:

Previous treatment with radiotherapy to the bladder, systemic chemotherapy or immune checkpoint inhibitors. Prior intravesical BCG treatment for non-muscle invasive bladder cancer is allowed.
Presence of regional lymph node or metastatic extension of the disease.
Concurrent treatment with other experimental drugs (within 30 days prior to study entry) or other anti-cancer therapy.
History of prior malignancies within the preceding 5 years other than previously treated basal cell carcinoma of the skin, non-muscle invasive bladder cancer, incidental prostate carcinoma Stage T1a well differentiated prostatic carcinoma in men (Gleason = 3+3, PSA <5) and carcinoma in situ of the cervix.
Evidence of tumour-related moderate/severe hydronephrosis unless stented or with nephrostomy to preserve renal function.
Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative chemoradiotherapy.
Bulky T3/T4a tumours unsuitable for curative treatment (i.e. > 5 cm in any dimension). Tumours measures must be done post-TUR via CT scan.
Patients with serious uncontrolled infection.
Has a known history of active BT (Bacillus Tuberculosis).
Has known history of, or any evidence of active, non-infectious pneumonitis.
Autoimmune diseases other than vitiligo, type I diabetes mellitus, residual hypothyroidism requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid antibody (HCV-Ab) indicating acute or chronic infection.
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Subjects with a condition requiring systemic treatment with either corticosteroids (equivalent to > 10 mg/day prednisone) or other immune-suppressive medications within 14 days of study drug administration.
Women of child-bearing potential unwilling to be abstinent or use effective methods of birth control.
+1 more criteria

EFFICACY OF ATEZOLIZUMAB CONCURRENT WITH RADIOTHERAPY IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations