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

  • End date
    Oct 30, 2025
  • participants needed
  • sponsor
Updated on 12 September 2021


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).

Condition Metastatic Urothelial Cancer, Unresectable Locally Advanced Urothelial Cancer
Treatment tremelimumab, durvalumab, Cisplatin + Gemcitabine, Carboplatin + Gemcitabine
Clinical Study IdentifierNCT03682068
Last Modified on12 September 2021


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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

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
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