Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

Not Recruiting

Trial ID: NCT02369874


This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

Official Title

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Alice C. Fan
Alice C. Fan

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


Inclusion Criteria: - Age ≥18 years; - Written informed consent obtained from the
patient/legal representative; - Histologically or cytologically confirmed recurrent or
metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative
systemic treatment regimen for recurrent or metastatic disease that must have contained a
platinum agent OR progression within 6 months of the last dose of platinum given as part of
multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN
by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; -
No prior exposure to immune-mediated therapy; - Adequate organ and marrow function;
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female
pre-menopausal patients. Exclusion Criteria: - Histologically or cytologically confirmed
squamous cell carcinoma of any other primary anatomic location in the head and neck; -
Received more than 1 palliative systemic regimen for recurrent or metastatic disease; -Any
concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer
treatment; - Receipt of any investigational anticancer therapy within 28 days or 5
half-lives; - Receipt of last dose of an approved (marketed) anticancer therapy
(chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the
first dose of study treatment; - Major surgical procedure within 28 days prior to the first
dose of Investigational Product; - Any unresolved toxicity NCI CTCAE Grade ≥2 from previous
anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values
defined in the inclusion criterion; - Current or prior use of immunosuppressive medication
within 14 days before the first dose of their assigned Investigational Product; - History
of allogeneic organ transplantation; - Active or prior documented autoimmune or
inflammatory disorders; - Uncontrolled intercurrent illness; - Patients with a history of
brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT
interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs)
using Fridericia's Correction; - History of active primary immunodeficiency; - Active
tuberculosis; - Active infection including hepatitis B, hepatitis C or human
immunodeficiency virus (HIV); - Receipt of live, attenuated vaccine within 30 days prior to
the first dose of Investigational Product; - Pregnant or breast-feeding female patients; -
Known allergy or hypersensitivity to Investigational Product


drug: MEDI4736

drug: MEDI4736 + Tremelimumab

drug: Standard of Care

Not Recruiting

Contact Information

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

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