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Clinical Trials in the USA / NCT02516241
Active, not recruiting Phase 3

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

NCT02516241 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2015-11-02
Last updated
2026-07-14

Condition(s) studied

Urothelial Cancer

Investigational drug(s) / intervention(s)

MEDI4736 (Durvalumab)TremelimumabCisplatinCarboplatinGemcitabine

MEDI4736 (Durvalumab): IV infusion

Tremelimumab: IV infusion

Cisplatin: IV infusion

Carboplatin: IV infusion

Gemcitabine: IV infusion

Study summary

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)

Trial sites (222)

FacilityCityRegionStatus
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.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT02516241 on ClinicalTrials.gov ↗ ← All trials in the USA