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

Conditions

• Infiltrating Bladder Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  1500 mg IV D1 every 28 days (2 doses for each patient)
• Tremelimumab — DRUG
  75 mg IV D1 every 28 days ((2 doses for each patient)
• MVAC Protocol — DRUG
  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

Study Details

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.

Key Dates

Start date

Dec 6, 2018

Status verified

Mar 2024

Primary completion

Jun 30, 2024

Completion

Sep 30, 2025

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ARM A: durvalumab + ddMVAC
  Durvalumab + ddMVAC Durvalumab 1500 mg IV D1 every 28 days Durvalumab will be administered at the hospital every 28 days prior to administration of ddMVAC on D1.
• Experimental: ARM B: durvalumab + tremelimumab+ ddMVAC
  durvalumab + tremelimumab + ddMVAC Tremelimumab 75 mg IV D1 every 28 days Tremelimumab will be administered first, with durvalumab infusion starting approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion. Infusion of ddMVAC will start approximately 1 hour after completion of durvalumab.

Primary Outcome Measure

Toxicity Grade [ Time Frame: 68 months ]