NCT03691714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

6.1 years

First QC Date

September 28, 2018

Last Update Submit

December 6, 2023

Conditions

Recurrent Head and Neck CancerHead and Neck CancerHead and Neck NeoplasmsMetastatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Imaging review using RECIST 1.1

    24 months

Secondary Outcomes (5)

  • Adverse events

    24 months

  • Disease control rate

    6 months

  • Progression-free survival

    24 months

  • Overall survival

    24 months

  • Duration of response

    24 months

Study Arms (1)

Durvalumab and Cetuximab

EXPERIMENTAL

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: DurvalumabDrug: Cetuximab

Interventions

DurvalumabDRUG

Two hour infusion

Also known as: MEDI4736
Durvalumab and Cetuximab
CetuximabDRUG

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

Durvalumab and Cetuximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Nasopharyngeal and salivary gland tumors
  • Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Health

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasm Metastasis

Interventions

durvalumabCetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Shuchi Gulati, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 2, 2018

Study Start

October 23, 2018

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)