# VOLGA (NCT04960709)

> 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

No report yet. It can be ordered.

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT04960709
- Phase: PHASE3
- Status: ACTIVE_NOT_RECRUITING
- Sponsor: AstraZeneca
- Conditions: Muscle Invasive Bladder Cancer
- Interventions: Durvalumab; Tremelimumab; Enfortumab Vedotin; Radical Cystectomy
- Enrollment: 712
- Primary outcome: To assess the safety and tolerability as evaluated by adverse events occurring throughout the study (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (blood pressure in mmHg) (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (pulse rate) in beats per minute (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (respiration rate) in breaths per minute (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (temperature) in degrees Celsius (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by liver function (Safety Run-In part)
- Primary outcome: Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by kidney function (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by thyroid function (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in haematology (Safety Run-In part)
- Primary outcome: To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as as assessed by ECG (pulse rate) (Safety Run-In part)
- Primary outcome: Changes in WHO/ECOG performance status (Safety Run-In part)
- Primary outcome: Compare efficacy of durvalumab + tremelimumab + EV (Arm 1) relative to cystectomy (Arm 3) and durvalumab + EV (Arm 2) relative to cystectomy (Arm 3) on EFS (Main Study)

## Preliminary discovery

Commentary in our index that names this trial so far. Final coverage is set when the report is built.

- X threads: 91
- Podcasts: 52
- YouTube: 41

## Order

Deep, $1,950, price fixed at order: https://www.erudio.com/contact?report=volga-nct04960709

## Free preview

POST https://www.erudio.com/api/trial-requests with {"nct_id": "NCT04960709", "email": "<work email>"}; the inbox owner confirms by the emailed link.