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Completed

NCT Number: NCT02262741

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subjects
  • 18 years and older
  • Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
  • Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
  • Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.

Exclusion criteria

  • Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
  • Concurrent or prior use of immunosuppressive medication within 14 days
  • Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.

Treatment and study plan

MEDI4736

Biological

MEDI4736 will be administered by IV infusion in combination with tremelimumab.

Tremelimumab

Biological

Tremelimumab will be administered by IV infusion in combination with MEDI4736.

Primary outcomes

  1. Number of subjects reporting adverse events

    Time frame: Screening through 3 months after the last dose of study medication

  2. Number of subjects reporting serious adverse events

    Time frame: Screening through 3 months after the last dose of study medication

  3. Number of subjects experiencing dose-limiting toxicities

    Time frame: First dose of study medications through 4 weeks after the first dose of study medication

  4. Change from Baseline in laboratory evaluations

    Time frame: Screening through 3 months after the last dose of study medication

  5. Change from Baseline in electrocardiograms

    Time frame: Screening through 3 months through last dose of study medication

  6. Change from Baseline in vital signs

    Time frame: Screening through 3 months after the last dose of study medication

Secondary outcomes

  1. Objective Response Rate

    Time frame: Screening through 5 years after the last subject receives the first dose of study medication

  2. Individual MEDI4736 concentrations

    Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication

  3. Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736

    Time frame: First dose of MEDI4736 through 6 months after the last dose of study medication

  4. Disease Control Rate

    Time frame: Screening through 5 years after the last subject receives the first dose of study medication

  5. Duration of Response

    Time frame: Screening through 5 years after the last subject receives the first dose of study medication

  6. Progression Free Survival

    Time frame: Screening through 5 years after the last subject receives the first dose of study medication

  7. Overall Survival

    Time frame: Screening through 5 years after the last subject receives the first dose of study medication

  8. Individual tremelimumab concentrations

    Time frame: First dose of tremelimumab through 3 months after the last dose of study medication

  9. MEDI4736 area under the concentration-curve

    Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication

  10. Tremelimumab area under the concentration-curve

    Time frame: First dose of tremelimumb through 3 months after the last dose of study medication

  11. Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab

    Time frame: First dose of tremelimumab through 6 months after the last dose of study medication

Other outcomes

  1. Changes in Biomarkers

    Time frame: Screening through 3 months after the last patient receives the first dose of study medication

    Evaluate biomarkers that may correlate with clinical activity of MEDI4736 monotherapy and in combination with tremelimumab

  2. Change from Baseline in Patient-Reported Outcomes

    Time frame: Screening through 5 years after the last patient receives the first dose of study medication

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2014
Registry last updated
Oct 23, 2017

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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