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

Primary Purpose

Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Durvalumab
Cetuximab
Sponsored by
Trisha Wise-Draper
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UC Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Durvalumab and Cetuximab

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate
Imaging review using RECIST 1.1

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2018
Last Updated
May 5, 2023
Sponsor
Trisha Wise-Draper
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03691714
Brief Title
Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trisha Wise-Draper
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms, Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab and Cetuximab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Two hour infusion
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Two hour infusion for loading dose followed by weekly one hour infusion
Primary Outcome Measure Information:
Title
Objective response rate
Description
Imaging review using RECIST 1.1
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
Percentage of adverse events using CTCAE v 5.0
Time Frame
24 months
Title
Disease control rate
Description
Combined complete response, partial response, and stable disease
Time Frame
6 months
Title
Progression-free survival
Description
Imaging review using RECIST 1.1
Time Frame
24 months
Title
Overall survival
Description
Date of on treatment to date of death
Time Frame
24 months
Title
Duration of response
Description
Date of initial response to progressive disease
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuchi Gulati, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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