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

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 Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: D910PC00001
  • Secondary ID: N/A
  • NTC ID: NCT04960709
  • Sponsor: AstraZeneca

BRIEF SUMMARY

A Global 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 Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer

DETAILED DESCRIPTION

Not provided

  • Overall Status
    Recruiting
  • Start Date
    August 5, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Safety and Tolerability as evaluated by adverse events occurring throughout the study

Primary Outcome 1 - Timeframe: At completion of study treatment by the last patient and at 3 months.

Primary Outcome 2 - Measure: 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)

Primary Outcome 2 - Timeframe: Up to 84 months

Primary Outcome 3 - Measure: Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed ssessed by vital signs (pulse rate) in beats per minute

Primary Outcome 3 - Timeframe: Up to 84 months

Primary Outcome 4 - Measure: 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

Primary Outcome 4 - Timeframe: Up to 84 months

Primary Outcome 5 - Measure: 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

Primary Outcome 5 - Timeframe: Up to 84 months

Primary Outcome 6 - Measure: 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

Primary Outcome 6 - Timeframe: Up to 84 months

Primary Outcome 7 - Measure: Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by kidney function

Primary Outcome 7 - Timeframe: Up to 84 months

Primary Outcome 8 - Measure: 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

Primary Outcome 8 - Timeframe: Up to 84 months

Primary Outcome 9 - Measure: Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in haematology

Primary Outcome 9 - Timeframe: Up to 84 months

Primary Outcome 10 - Measure: Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by ECG (pulse rate)

Primary Outcome 10 - Timeframe: Up to 84 months

Primary Outcome 11 - Measure: Changes in WHO/ECOG performance status

Primary Outcome 11 - Timeframe: Up to 84 months

Primary Outcome 12 - Measure: Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on pCR rate

Primary Outcome 12 - Timeframe: Up to 3 years

Primary Outcome 13 - Measure: Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on EFS

Primary Outcome 13 - Timeframe: Up to 3 years

CONDITION

  • Muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology;

- 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.
Exclusion criteria:
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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

Facility Status Contact
Facility: Research Site
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Las Vegas, Nevada 89102
United States
Status: Recruiting Contact: N/A