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

University of Cincinnati35 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

Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame: RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months.

Secondary Outcomes

Treatment Related Adverse Events

Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).

Time frame: From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 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 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time frame: 24 months

Overall Survival

Date of on treatment to date of death

Time frame: 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.