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Summary

for people ages 18–130 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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)

Details

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.

Keywords

Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck Head and neck cancer; SCCHN Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18–130

  • 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.

You CAN'T join if...

  • 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

Locations

  • Research Site
    San Francisco, California, United States
  • Research Site
    Santa Monica, California, United States
  • Research Site
    Los Angeles, California, United States
  • Research Site
    Duarte, California, United States
  • Research Site
    Whittier, California, United States
  • Research Site
    Long Beach, California, United States
  • Research Site
    Fullerton, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT02207530
Phase
Phase 2
Lead Scientist
Alain Algazi
Study Type
Interventional
Last Updated
April 28, 2017