Informations générales (source: ClinicalTrials.gov)
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) (VOLGA)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
août 2021
septembre 2028
30 avril 2025
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 Cisplantin 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 trial. 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 + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab
vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Christine ABRAHAM | 05/05/2025 07:12:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Research Site - 13273 - Marseille CEDEX - France | Contact (sur clinicalTrials) | ||||
| Research Site - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31130 - Quint-Fonsegrives - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 42270 - Saint-Priez En Jarez - France | Contact (sur clinicalTrials) | ||||
| Research Site - 54519 - Vandoeuvre les Nancy - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 63011 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Research Site - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Research Site - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69495 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| Research Site - 80090 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92151 - Suresnes Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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)
- 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.