Overview

This trial is active, not recruiting.

Condition recurrent or metastatic pd-l1-positive squamous cell carcinoma of the head and neck (scchn)
Treatment medi4736
Phase phase 2
Target PD-1
Sponsor AstraZeneca
Collaborator PRA Health Sciences
Start date October 2014
End date December 2016
Trial size 112 participants
Trial identifier NCT02207530, D4193C00001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MEDI4736 monotherapy
medi4736
MEDI4736 monotherapy

Primary Outcomes

Measure
Objective Response Rate (ORR)
time frame: Up to 2 years

Secondary Outcomes

Measure
Duration of response (DoR)
time frame: Up to 2 years
Disease control rate (DCR)
time frame: Up to 2 years
Quality of Life
time frame: Up to 2 years
Progression-free survival (PFS)
time frame: Up to 2 years
Overall survival (OS)
time frame: Up to 2 years

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

Official title 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)
Principal investigator Dan Paul Zandberg, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.