臨床研究等提出・公開システム

A Phase III Randomized, Open-Label, Multicenter Study 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 Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer
(VOLGA)

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
(VOLGA)

Boulous Suliman

AstraZeneca

AstraZeneca AB, 151 85 Soedertaelje, Sweden

Suli.boulos@astrazeneca.com

Contact for clinical trial information

Fortrea Japan K.K.

Harumi Triton Square Office Tower Y 8F, 1-8-11 Harumi, Chuo-ku, Tokyo

+81-3-6837-9500

Fortrea_Japan_AZ_VOLGA@fortrea.com

Recruiting

May. 16, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

- 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)

-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.

Both

Muscle Invasive Bladder Cancer

Arm 1:
- Neoadjuvant treatment for three 21-day cycles (ie, Neoadjuvant Weeks 1 through 9) with durvalumab 1500 mg (Day 1 of each cycle) + tremelimumab 75 mg (Cycle 1 Day 1 and Cycle 2 Day 8 only) + EV 1.25 mg/kg (Day 1 and Day 8 of each cycle)
- Radical cystectomy
- Adjuvant treatment for nine 28-day cycles (ie, Adjuvant Weeks 1 through 36) with durvalumab 1500 mg (Day 1 of each cycle) + tremelimumab 75 mg (Day 1 of first cycle only)
Arm 2:
- Neoadjuvant treatment for three 21-day cycles (ie, Neoadjuvant Weeks 1 through 9) with durvalumab 1500 mg (Day 1 of each cycle) + EV 1.25 mg/kg (Day 1 and Day 8 of each cycle)
- Radical cystectomy
- Adjuvant treatment for nine 28-day cycles (ie, Adjuvant Weeks 1 through 36) with durvalumab 1500 mg (Day 1 of each cycle)
Arm 3:
- No neoadjuvant treatment
- Radical cystectomy
- No adjuvant treatment; however, participants may receive adjuvant therapy if approved by local health authorities as a standard of care and available in the local market. Currently, only nivolumab is approved as adjuvant treatment for MIBC based on pathological high risk criteria (defined as pT3, pT4, or pN+).
Optional local standard platinum-based adjuvant treatment for Japanese patients with pT3/4 and/or pN+ disease after consultation with AstraZeneca (ie, gemcitabine with either cisplatin [eg, full-dose, low-dose, or split-dose] or carboplatin [AUC 4-5] for 2-4 cycles).

Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 3 years.

+81-45-520-2222

Sept. 10, 2021

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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