Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

Conditions

• Metastatic Urothelial Cancer
• Unresectable Locally Advanced Urothelial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Durvalumab IV (intravenous infusion)
• Tremelimumab — DRUG
  Tremelimumab IV (intravenous infusion)
• Cisplatin + Gemcitabine — DRUG
  Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
• Carboplatin + Gemcitabine — DRUG
  Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Study Details

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).

Key Dates

Start date

Sep 27, 2018

Status verified

May 2026

Primary completion

Jun 1, 2026

Completion

Jun 1, 2027

Study Design

Enrollment

1,246 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab in Combination with SoC Chemotherapy
  Durvalumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine
• Experimental: Durvalumab in Combination with Tremelimumab+SoC Chemotherapy
  Durvalumab and Tremelimumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks Tremelimumab will be provided for 4 cycles. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine
• Active Comparator: SoC Chemotherapy
  Patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: approximately 5 years ]

Locations (23)

Find similar trials in Birmingham, AL

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