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

Sponsor

Shuchi Gulati (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03691714

Collaborator

AstraZeneca (Industry)

Enrollment

Location

Arm

52.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Head and Neck Cancer Head and Neck Cancer Head and Neck Neoplasms Metastatic Cancer	Drug: Durvalumab Drug: Cetuximab	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Oct 23, 2018

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Durvalumab and Cetuximab Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance	Drug: Durvalumab Two hour infusion Other Names: MEDI4736 Drug: Cetuximab Two hour infusion for loading dose followed by weekly one hour infusion

Arm

Intervention/Treatment

Experimental: Durvalumab and Cetuximab

Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance

Drug: Durvalumab

Two hour infusion

Other Names:

MEDI4736

Drug: Cetuximab

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

Outcome Measures

Primary Outcome Measures

Objective response rate [24 months]
Imaging review using RECIST 1.1

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Health	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

Shuchi Gulati
AstraZeneca

Investigators

Principal Investigator: Shuchi Gulati, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shuchi Gulati, Assistant Professor of Medicine, University of Cincinnati

ClinicalTrials.gov Identifier:

NCT03691714

Other Study ID Numbers:

UCCI-HN-17-02
EAR-17-12765

First Posted:

Oct 2, 2018

Last Update Posted:

Nov 30, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Recurrence

Cetuximab

Durvalumab

Study Results

No Results Posted as of Nov 30, 2021