A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
* Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) \<60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss • CTCAE Grade ≥2 peripheral neuropathy • New York Heart Association ≥Class III heart failure.
* Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization.
Exclusion Criteria:
* Prior exposure to immune-mediated therapy, including but not limited to, other anti cytotoxic T-lymphocyte-associated protein 4 (CTLA 4), anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
* History of allogenic organ transplantation that requires use of immunosuppressive agents.
* Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca.
* Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.
Primary outcome measure(s)
To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set — From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set — From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Trial sites (222)
Facility
City
Region
Status
Research Site
Los Angeles
California
Research Site
Stanford
California
Research Site
Aurora
Colorado
Research Site
New Haven
Connecticut
Research Site
Tampa
Florida
Research Site
Atlanta
Georgia
Research Site
Louisville
Kentucky
Research Site
Boston
Massachusetts
Research Site
Ann Arbor
Michigan
Research Site
Detroit
Michigan
Research Site
Omaha
Nebraska
Research Site
New York
New York
Research Site
New York
New York
Research Site
Memphis
Tennessee
Research Site
Nashville
Tennessee
Research Site
Seattle
Washington
Research Site
Box Hill
Australia
Research Site
Elizabeth Vale
Australia
Research Site
Macquarie University
Australia
Research Site
St Leonards
Australia
Research Site
Waratah
Australia
Research Site
Linz
Austria
Research Site
Vienna
Austria
Research Site
Vienna
Austria
Research Site
Brussels
Belgium
Research Site
Brussels
Belgium
Research Site
Leuven
Belgium
Research Site
Liège
Belgium
Research Site
Barretos
Brazil
Research Site
Belo Horizonte
Brazil
Research Site
Ijuí
Brazil
Research Site
Itajaí
Brazil
Research Site
Porto Alegre
Brazil
Research Site
Porto Alegre
Brazil
Research Site
Porto Alegre
Brazil
Research Site
Rio de Janeiro
Brazil
Research Site
Rio de Janeiro
Brazil
Research Site
São José do Rio Preto
Brazil
Research Site
São Paulo
Brazil
Research Site
São Paulo
Brazil
+ 182 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.