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

NCT03549715 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-03-06

No results posted yet for this study

Summary

This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC.

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

Sponsors & Collaborators

  • Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

    lead OTHER

Principal Investigators

  • Constance THIBAULT, MD · Hôpital Européen Georges Pompidou, Oncology department of Pr Stéphane OUDARD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2024-06-30
Completion
2025-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT03549715 on ClinicalTrials.gov