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Brief Title: First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.

INTRODUCTION

  • Org Study ID: D933SC00001
  • Secondary ID: N/A
  • NTC ID: NCT03682068
  • Sponsor: AstraZeneca

BRIEF SUMMARY

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

  • Overall Status
    Recruiting
  • Start Date
    September 27, 2018
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Survival (OS)

Primary Outcome 1 - Timeframe: approximately 5 years

CONDITION

  • Unresectable Locally Advanced Urothelial Cancer
  • Metastatic Urothelial Cancer

ELIGIBILITY

Key Inclusion Criteria:
Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)

- Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment].

- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.

- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment

- Adequate organ and marrow function as defined in the protocol

- Life expectancy ≥12 weeks in the opinion of the investigator

- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
Key Exclusion Criteria:
Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.

- No severe concomitant condition that requires immunosuppression medication

- Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

- Patients who may be eligible for or are being considered for radical resection during the course of the study.

- Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

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
Beijing, 100034
China
Status: Recruiting Contact: N/A
Facility: Research Site
Changchun, 410008
China
Status: Recruiting Contact: N/A
Facility: Research Site
Changsha, 410013
China
Status: Recruiting Contact: N/A
Facility: Research Site
Changsha, 400010
China
Status: Recruiting Contact: N/A
Facility: Research Site
Chongqing, 400038
China
Status: Recruiting Contact: N/A
Facility: Research Site
Chongqing, 116027
China
Status: Recruiting Contact: N/A
Facility: Research Site
Guangzhou, 510060
China
Status: Recruiting Contact: N/A
Facility: Research Site
Guangzhou, 510280
China
Status: Recruiting Contact: N/A
Facility: Research Site
Hangzhou, 310009
China
Status: Recruiting Contact: N/A
Facility: Research Site
Hangzhou, 310014
China
Status: Recruiting Contact: N/A
Facility: Research Site
Hangzhou, 310022
China
Status: Recruiting Contact: N/A
Facility: Research Site
Hangzhou, 150049
China
Status: Recruiting Contact: N/A
Facility: Research Site
Jinan, 250021
China
Status: Recruiting Contact: N/A
Facility: Research Site
Nanchang, 2100008
China
Status: Recruiting Contact: N/A
Facility: Research Site
Nanjing, 200003
China
Status: Recruiting Contact: N/A
Facility: Research Site
Shanghai, 200072
China
Status: Recruiting Contact: N/A
Facility: Research Site
Shanghai, 200127
China
Status: Recruiting Contact: N/A
Facility: Research Site
Shenyang, 215006
China
Status: Recruiting Contact: N/A
Facility: Research Site
Suzhou, 300211
China
Status: Recruiting Contact: N/A
Facility: Research Site
Tianjin, 830000
China
Status: Recruiting Contact: N/A
Facility: Research Site
Urumqi, 430030
China
Status: Recruiting Contact: N/A
Facility: Research Site
Xi'an, 656 91
China
Status: Recruiting Contact: N/A
Facility: Research Site
Xiamen, 500 05
China
Status: Recruiting Contact: N/A
Facility: Research Site
Taipei City, 10300
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taipei, 10400
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taoyuan, 40002
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Ho Chi Minh,
Vietnam
Status: Recruiting Contact: N/A