Study of MEDI4736 With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Official Title

A Phase III, Randomized, Open-Label, Controlled, Multi-Centre, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

Summary:

A Phase III, Randomized, Open-Label, Controlled, Multi-Centre, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

Trial Description

Primary Outcome:

  • The efficacy of MEDI4736 + tremelimumab combination therapy compared to Standard of Care (SoC) in terms of Progression-Free Survival (PFS) and Overall Survival (OS) in patients with Urothelial Cancer (UC)
Secondary Outcome:
  • The efficacy of MEDI4736 monotherapy compared to SoC in terms of PFS and OS in patients with UC
  • Health related quality of life (HRQoL) in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-BL) questionnaire
  • The pharmacokinetics (PK) - Peak concentration (Cmax) of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
  • The pharmacokinetics (PK) - Trough concentration (Ctrough) of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
  • The immunogenicity of MEDI4736 and tremelimumab combination therapy and MEDI4736 monotherapy
  • The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR)
  • The efficacy of MEDI4736 monotherapy compared to SoC in terms of ORR
This is a randomized, open-label, controlled, multi-centre, global Phase III study to determine the efficacy and safety of MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) first-line chemotherapy in treatment-naïve patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) and to allow sufficient flexibility for Investigators and patients to select the agents that reflect their normal clinical practice and national guidelines. The patients enrolled in the study will be randomized 1:1:1 to receive treatment with combination therapy, monotherapy, or SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility). Patients will be treated with MEDI4736 or MEDI4736 with tremelimumab, or treated with SoC until progressive disease (PD) is confirmed, unacceptable toxicity occurs, withdrawal of consent, or another discontinuation criterion is met. Patients will be followed for up to 2 years.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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