Clinical Trials /

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

NCT02262741

Description:

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.

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

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: D4190C00011
  • NCT ID: NCT02262741

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
MEDI4736MEDI4736 + tremelimumab
tremelimumabMEDI4736 + tremelimumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
MEDI4736 + tremelimumabExperimental
  • MEDI4736
  • tremelimumab

Eligibility Criteria

        Inclusion Criteria:

          1. Male and female subjects

          2. 18 years and older

          3. 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.

          4. Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1
             required) in the recurrent/metastatic setting.

          5. Subject eligibility will be based on PD-L1 expression as determined by a specified IHC
             assay.

        Exclusion Criteria:

          1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
             treatment, receipt of last dose of an approved anticancer therapy within 21 days

          2. Concurrent or prior use of immunosuppressive medication within 14 days

          3. Active or prior documented autoimmune or inflammatory disease within 3 years with some
             exceptions.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subjects reporting adverse events
Time Frame:Screening through 3 months after the last dose of study medication
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate
Time Frame:Screening through 5 years after the last subject receives the first dose of study medication
Safety Issue:
Description:
Measure:Individual MEDI4736 concentrations
Time Frame:First dose of MEDI4736 through 3 months after the last dose of study medication
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Disease Control Rate
Time Frame:Screening through 5 years after the last subject receives the first dose of study medication
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:Screening through 5 years after the last subject receives the first dose of study medication
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:Screening through 5 years after the last subject receives the first dose of study medication
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Screening through 5 years after the last subject receives the first dose of study medication
Safety Issue:
Description:
Measure:Individual tremelimumab concentrations
Time Frame:First dose of tremelimumab through 3 months after the last dose of study medication
Safety Issue:
Description:
Measure:MEDI4736 area under the concentration-curve
Time Frame:First dose of MEDI4736 through 3 months after the last dose of study medication
Safety Issue:
Description:
Measure:Tremelimumab area under the concentration-curve
Time Frame:First dose of tremelimumb through 3 months after the last dose of study medication
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:MedImmune LLC

Last Updated

October 23, 2017