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

• Status: Completed
• Trial end date: 2020-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: PRA Health Sciences
• Treatments: Antibodies, Monoclonal; Durvalumab

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