NCT03549715View on ClinicalTrials.gov

NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

December 6, 2018

Primary Completion Date

June 30, 2024

Study Completion Date

September 30, 2025

Conditions
Infiltrating Bladder Urothelial Carcinoma
Interventions
DRUG

Durvalumab

1500 mg IV D1 every 28 days (2 doses for each patient)

DRUG

Tremelimumab

75 mg IV D1 every 28 days ((2 doses for each patient)

DRUG

MVAC Protocol

"1. Methotrexate 30 mg/m2 IV D1~2. Vinblastine 3 mg/m2 IV D1~3. Adriamycin (doxorubicin) 30 mg/m2 IV D1~4. Cisplatin 70 mg/m2 IV D1"

Trial Locations (15)

13009

Institut Paoli Calmettes, Marseille

31059

Institut Claudius Regaud, Toulouse

33075

Hôpital Saint André, CHU de Bordeaux, Bordeaux

35042

Centre Eugène Marquis, Rennes

37170

Sasu Roc37, Chambray-lès-Tours

67000

Hôpitaux universitaires de Strasbourg, Strasbourg

69008

Centre Leon Berard, Lyon

75013

Groupe Hospitalier Pitié-Salpetrière, Paris

75014

Institut Mutualiste Montsouris, Paris

75015

Hôpital Européen Georges Pompidou, Paris

75679

Hôpital Cochin, Paris

94000

CHU Henri-Mondor, Créteil

94160

Hia Begin, Saint-Mandé

94805

Institut Gustave Roussy, Villejuif

06100

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

OTHER