Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck



Status:Active, not recruiting
Healthy:No
Age Range:18 - 127
Updated:2/10/2019
Start Date:October 23, 2014
End Date:December 31, 2019

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A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
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