NCT03674424View on ClinicalTrials.gov

Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA Trial)

PHASE2CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

December 7, 2021

Study Completion Date

January 30, 2025

Conditions
Non-metastatic Muscle Invasive Bladder Cancer
Interventions
DRUG

Avelumab

Chemotherapy with or without avelumab followed by surgery

PROCEDURE

cystectomy

Cystectomy 3 to 6 weeks after last administration of chemotherapy

COMBINATION_PRODUCT

CG

Chemotherapy 4 cycles of 3 weeks

COMBINATION_PRODUCT

DD-MVAC

Chemotherapy 4 cycles of 2 weeks

COMBINATION_PRODUCT

PG

Chemotherapy 2 cycles of 4 weeks

Trial Locations (10)

1000

Institut Jules Bordet, Brussels

2650

UZAntwerpen, Edegem

4000

CHU de Liège Sart Tilman, Liège

5000

CHU Namur - Sainte Elisabeth, Namur

6000

Grand Hôpital de Charleroi, Gilly

7000

Centre Hospitalier Universitaire et Psychiatrique de Mons-Borinage, Mons

59000

Centre Oscar Lambret, Lille

67091

Hôpitaux universitaires de Strasbourg, Strasbourg

75014

Groupe Hospitalier Paris Saint Joseph, Paris

75475

Hôpital Saint Louis, Paris

Sponsors
All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

Jules Bordet Institute

OTHER

NCT03674424 - Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA Trial) | Biotech Hunter | Biotech Hunter