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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Trisha Wise-Draper，University of Cincinnati

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response rate[ Time Frame: 24 months ]

Imaging review using RECIST 1.1

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Adverse events[ Time Frame: 24 months ]
Percentage of adverse events using CTCAE v 5.0
Disease control rate[ Time Frame: 6 months ]
Combined complete response, partial response, and stable disease
Progression-free survival[ Time Frame: 24 months ]
Imaging review using RECIST 1.1
Overall survival[ Time Frame: 24 months ]
Date of on treatment to date of death
Duration of response[ Time Frame: 24 months ]
Date of initial response to progressive disease

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Brief Summary

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.

Detailed Description

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Durvalumab
One hour infusion
Drug: Cetuximab
Two hour infusion for loading dose followed by weekly one hour infusion

Study Arms

Experimental: Durvalumab and Cetuximab
Durvalumab 1500mg IV every 4 weeks Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues for a maximum of 24 months while Cetuximab may continue as maintenance

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2022

Estimated Primary Completion Date

October 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Trisha Wise-Draper，University of Cincinnati

Study Sponsor ^ICMJE

Trisha Wise-Draper

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Trisha Wise, MD, PhD University of Cincinnati

PRS Account

University of Cincinnati

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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