Clinical Trials /

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

NCT02207530

Description:

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

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Phase II Study of MEDI4736 <span class="go-doc-concept go-doc-intervention">Monotherapy</span> in Treatment of Recurrent or Metastatic Squamous Cell <span class="go-doc-concept go-doc-disease">Carcinoma</span> of the Head and Neck

Title

  • Brief Title: Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
  • 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)
  • Clinical Trial IDs

    NCT ID: NCT02207530

    ORG ID: D4193C00001

    Trial Conditions

    Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN)

    Trial Interventions

    Drug Synonyms Arms
    MEDI4736 MEDI4736

    Trial Purpose

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

    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 1 systemic regimen for
    recurrent or metastatic disease that must have contained a platinum agent.

    Trial Arms

    Name Type Description Interventions
    MEDI4736 Experimental MEDI4736 monotherapy MEDI4736

    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
    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 regimen for recurrent or metastatic disease

    - Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy
    for cancer treatment

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 130 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Objective Response Rate (ORR)

    Secondary Outcome Measures

    Duration of response (DoR)

    Disease control rate (DCR)

    Quality of Life

    Progression-free survival (PFS)

    Overall survival (OS)

    Trial Keywords

    Head and neck cancer; SCCHN