Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin

Running, not enrolling · Phase 3

Conditions studied: Muscle Invasive Bladder Cancer

In brief

A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplatin based chemotherapy Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer. The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or the duplet combination of Durvalumab and Enfortumab vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC). VOLGA trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 677 patients, who will receive triplet combination, duplet combination or currently approved SOC in the main study. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Enfortumab Vedotin and 2 cycles of Tremelimumab or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will receive either adjuvant Durvalumab or adjuvant Durvalumab and 1 cycle of Tremelimumab.

Key facts

Study ID

NCT04960709

Run by

AstraZeneca

People needed

712

Starts

2021-08-05

Expected to finish

2028-09-08

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented muscle-invasive UC of the bladder.
• Participants with transitional cell and mixed transitional/non-transitional cell histologies;
• Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0 (participants with T1 stage are allowed only with N1 disease)
• Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
• Medically fit for cystectomy and able to receive neoadjuvant therapy;
• Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
• ECOG performance status of 0,1,2 at enrollment.
• Availability of tumor sample prior to study entry;
• Must have a life expectancy of at least 12 weeks at randomization.
• Cisplatin-ineligible, following criteria based on Galsky et al 2011 OR Refuse cisplatin based chemotherapy (must be documented in the medical records)

You may not qualify if…

• Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
• Active infection
• Uncontrolled intercurrent illness
• Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.

Where it is running

• Research Site — Santa Monica, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Coeur d'Alene, Idaho, United States
• Research Site — Maywood, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Scarborough, Maine, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Brighton, Michigan, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Saddle Brook, New Jersey, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Research Site — Syracuse, New York, United States
• Research Site — Portland, Oregon, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — Orange, California, United States

Full record on ClinicalTrials.gov

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