Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 2Active Not RecruitingNCT03691714

Trisha Wise-Draper36 enrolled

Overview

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Head and Neck Cancer Head and Neck Cancer Head and Neck Neoplasms Metastatic Cancer

Interventions

DurvalumabDRUG

Two hour infusion

CetuximabDRUG

Two hour infusion for loading dose followed by weekly one hour infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight \> 30 kg * Histologically or cytologically confirmed recurrent or metastatic HNSCC * Not considered a candidate for other curative therapy (i.e. surgery/RT) * Documented progression of disease after receiving platinum based regimen * ECOG performance status 0-2 Exclusion Criteria: * Nasopharyngeal and salivary gland tumors * Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

Locations (1)

UC Health

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Objective response rate

Imaging review using RECIST 1.1

Time frame: 24 months

Secondary Outcomes

Adverse events

Percentage of adverse events using CTCAE v 5.0

Time frame: 24 months

Disease control rate

Combined complete response, partial response, and stable disease

Time frame: 6 months

Progression-free survival

Imaging review using RECIST 1.1

Time frame: 24 months

Overall survival

Date of on treatment to date of death

Time frame: 24 months

Duration of response

Date of initial response to progressive disease

Time frame: 24 months

Data from ClinicalTrials.gov

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