Clinical Trials /

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

NCT03691714

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03691714

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: UCCI-HN-17-02
  • SECONDARY ID: EAR-17-12765
  • NCT ID: NCT03691714

Conditions

  • Recurrent Head and Neck Cancer
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Metastatic Cancer

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Durvalumab and Cetuximab
CetuximabDurvalumab and Cetuximab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Durvalumab and CetuximabExperimentalDurvalumab 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
  • Durvalumab
  • Cetuximab

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate
Time Frame:24 months
Safety Issue:
Description:Imaging review using RECIST 1.1

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Trisha Wise-Draper

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