phase ii study of medi4736 monotherapy in treatment of recurrent or metastatic squamous cell carcinoma of the head and neck

Conditions: Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck

Summary: 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.

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

Keywords: head and neck cancer; scchn