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Completed

NCT Number: NCT03691714

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

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.

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Key information

Conditions

Recurrent Head and Neck Cancer Head and Neck Cancer Head and Neck Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC Health

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Durvalumab

Drug

Two hour infusion

Other names: MEDI4736

Cetuximab

Drug

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

Primary outcomes

  1. Objective Response Rate

    Time frame: RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months.

    Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary outcomes

  1. Treatment Related Adverse Events

    Time frame: From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 months.

    Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).

  2. Disease Control Rate

    Time frame: 6 months

    Combined complete response, partial response, and stable disease

  3. Progression-free Survival

    Time frame: 24 months

    Imaging review using RECIST 1.1 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  4. Overall Survival

    Time frame: 24 months

    Date of on treatment to date of death

Sponsors and collaborators

Lead sponsor

Trisha Wise-Draper

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2018
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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