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

Not Recruiting

Trial ID: NCT02516241


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

Official Title

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 Unresectable Stage IV Urothelial Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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

   - 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.


drug: Tremelimumab

drug: Cisplatin

drug: Carboplatin

drug: Gemcitabine

drug: MEDI4736 (Durvalumab)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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