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

NCT03674424 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2025-02-26

No results posted yet for this study

Summary

Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC).

Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.

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

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Jules Bordet Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-12-07
Completion
2025-01-30

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674424 on ClinicalTrials.gov