Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions
Interventions
investigational material(s)
Generic name etc : MEDI4736, MEDI4736 + Tremelimumab
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration fo
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
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 or more 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) 470ms or more 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety confirmatory - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed