Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR
Condition or disease
Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with PD-L1 positive recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), who have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
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Ages Eligible for Study:
18 Years to 130 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age ≥18 years
Written informed consent obtained from the patient/legal representative
Histologically confirmed recurrent or metastatic SCCHN
Tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
Confirmed PD-L1-positive SCCHN by Ventana SP263 assay
WHO/ECOG performance status of 0 or 1
At least 1 measurable lesion at baseline
No prior exposure to immune-mediated therapy
Adequate organ and marrow function
Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck
Received more than 1 systematic palliative regimen for recurrent or metastatic disease
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment
Prior randomization or treatment in a previous MEDI4736 and/or tremelimumab clinical study regardless of treatment arm assignment or 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 MEDI4736
History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders;
Uncontrolled intercurrent illness
Another primary malignancy
Patients with history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
History of active primary immunodeficiency
Known history of previous 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 MEDI4736
Pregnant or breast-feeding female patients
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results