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

MedImmune LLC71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

MEDI4736BIOLOGICAL

MEDI4736 will be administered by IV infusion in combination with tremelimumab.

tremelimumabBIOLOGICAL

Tremelimumab will be administered by IV infusion in combination with MEDI4736.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (23)

Research Site

Scottsdale, Arizona, United States

Research Site

Outcomes

Primary Outcomes

Number of subjects reporting adverse events

Time frame: Screening through 3 months after the last dose of study medication

Number of subjects reporting serious adverse events

Time frame: Screening through 3 months after the last dose of study medication

Number of subjects experiencing dose-limiting toxicities

Time frame: First dose of study medications through 4 weeks after the first dose of study medication

Change from Baseline in laboratory evaluations

Time frame: Screening through 3 months after the last dose of study medication

Change from Baseline in electrocardiograms

Time frame: Screening through 3 months through last dose of study medication

Change from Baseline in vital signs

Time frame: Screening through 3 months after the last dose of study medication

Secondary Outcomes

Objective Response Rate

Time frame: Screening through 5 years after the last subject receives the first dose of study medication

Individual MEDI4736 concentrations

Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication

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

Time frame: First dose of MEDI4736 through 6 months after the last dose of study medication

Disease Control Rate

Data from ClinicalTrials.gov

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