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

This study is ongoing, but not recruiting participants.
PRA Health Sciences
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: August 1, 2014
Last updated: October 19, 2016
Last verified: October 2016
Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

Condition Intervention Phase
Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Drug: MEDI4736
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To assess the efficacy in terms of ORR

Secondary Outcome Measures:
  • Duration of response (DoR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To further assess the efficacy in terms of DoR

  • Disease control rate (DCR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To further assess the efficacy in terms of DCR

  • Quality of Life [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To explore symptoms and health-related Quality of Life (QoL) using the questionnaires: EORTC QLQ-C30 v3 and the QLQ-H&N35 module

  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To further assess the efficacy in terms of PFS

  • Overall survival (OS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To further assess the efficacy in terms of OS

Other Outcome Measures:
  • Adverse events (AEs), physical examinations, laboratory findings [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability profile

Estimated Enrollment: 112
Study Start Date: October 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI4736
MEDI4736 monotherapy
Drug: MEDI4736
MEDI4736 monotherapy

Detailed 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.

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02207530

  Show 96 Study Locations
Sponsors and Collaborators
PRA Health Sciences
Principal Investigator: Dan Paul Zandberg, MD International Coordinating Investigator
Study Director: Trishna Goswami, MD Medical Director AstraZeneca
  More Information

Responsible Party: AstraZeneca Identifier: NCT02207530     History of Changes
Other Study ID Numbers: D4193C00001 
Study First Received: August 1, 2014
Last Updated: October 19, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: National Agency for the Safety of Medicine and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Georgia: Ministry of Labor, Health and Social Affairs of Georgia
Israel: Ministry of Health
Malaysia: National Pharmaceutical Control Bureau
South Korea: Ministry of Food and Drug Safety
Taiwan: Taiwan Food and Drug Administration, Ministry of Health and Welfare

Keywords provided by AstraZeneca:
Head and neck cancer; SCCHN

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on December 07, 2016