Clinical Trials /

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

NCT02262741

Description:

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

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

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (<span class="go-doc-concept go-doc-intervention">Durvalumab</span>) With <span class="go-doc-concept go-doc-intervention">Tremelimumab</span> in Head and Neck Cancer

Title

  • Brief Title: A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
  • Official Title: A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
  • Clinical Trial IDs

    NCT ID: NCT02262741

    ORG ID: D4190C00011

    Trial Conditions

    Squamous Cell Carcinoma of the Head and Neck

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the
    safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of
    MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous
    cell carcinoma of the head and neck.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    MEDI4736 + tremelimumab Experimental

    Eligibility Criteria

    Inclusion Criteria:

    1. Male and female subjects

    2. 18 years and older

    3. Histologically or cytologically confirmed recurrent or metastatic squamous cell
    carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that
    is incurable by local therapy.

    4. Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1
    required) in the recurrent/metastatic setting.

    5. Subject eligibility will be based on PD-L1 expression as determined by a specified
    IHC assay.

    Exclusion Criteria:

    1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
    treatment, receipt of last dose of an approved anticancer therapy within 21 days

    2. Concurrent or prior use of immunosuppressive medication within 14 days

    3. Active or prior documented autoimmune or inflammatory disease within 3 years with
    some exceptions.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 99 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Number of subjects reporting adverse events

    Number of subjects reporting serious adverse events

    Number of subjects experiencing dose-limiting toxicities

    Change from Baseline in laboratory evaluations

    Change from Baseline in electrocardiograms

    Change from Baseline in vital signs

    Secondary Outcome Measures

    Objective Response Rate

    Individual MEDI4736 concentrations

    Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736

    Disease Control Rate

    Duration of Response

    Progression Free Survival

    Overall Survival

    Individual tremelimumab concentrations

    MEDI4736 area under the concentration-curve

    Tremelimumab area under the concentration-curve

    Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab

    Trial Keywords