Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Recurrence
Intervention: MEDI4736
Intervention description: MEDI4736 monotherapy
Intervention MeSH terms: Durvalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Head and neck cancer; SCCHN

Summary:

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

Eligibility criteria:

        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