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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262741
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE October 2, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date October 23, 2017
Actual Study Start Date  ICMJE October 15, 2014
Actual Primary Completion Date September 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • Number of subjects reporting adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Number of subjects reporting serious adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
  • Change from Baseline in laboratory evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Change from Baseline in electrocardiograms [ Time Frame: Screening through 3 months through last dose of study medication ]
  • Change from Baseline in vital signs [ Time Frame: Screening through 3 months after the last dose of study medication ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • Number of subjects reporting adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Number of subjects reporting serious adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Percentage of subjects reporting serious adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Percentage of subjects reporting adverse events [ Time Frame: Screeing through 3 months after the last dose of study medication ]
  • Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
  • Change from Baseline in laboratory evaluations [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Change from Baseline in physical examinations [ Time Frame: Screening through 3 months through last dose of study medication ]
  • Change from Baseline in vital signs [ Time Frame: Screening through 3 months after the last dose of study medication ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • Objective Response Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Individual MEDI4736 concentrations [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  • 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 ]
  • Disease Control Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Duration of Response [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Progression Free Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Overall Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Individual tremelimumab concentrations [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  • MEDI4736 area under the concentration-curve [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  • Tremelimumab area under the concentration-curve [ Time Frame: First dose of tremelimumb through 3 months after the last dose of study medication ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • Objective Response Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Individual MEDI4736 concentrations [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  • 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 ]
  • Disease Control Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Duration of Response [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Progression of Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Overall Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
  • Individual tremelimumab concentrations [ Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication ]
  • MEDI4736 area under the concentration-curve [ Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication ]
  • Tremelimumab area under the concentration-curve [ Time Frame: First dose of tremelimumb through 3 months after the last dose of study medication ]
  • 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 ]
  • Percentage 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 ]
  • Percentage of subjects that develop detectable antidrug antibodies to tremelimumab [ Time Frame: First dose of tremelimumab through 6 months after the last dose of study medication ]
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2014)
  • 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
  • Change from Baseline in Patient-Reported Outcomes [ Time Frame: Screening through 5 years after the last patient receives the first dose of study medication ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Biological: MEDI4736
    MEDI4736 will be administered by IV infusion in combination with tremelimumab.
  • Biological: tremelimumab
    Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Study Arms  ICMJE Experimental: MEDI4736 + tremelimumab
Interventions:
  • Biological: MEDI4736
  • Biological: tremelimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2017)
71
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
164
Actual Study Completion Date  ICMJE September 21, 2017
Actual Primary Completion Date September 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02262741
Other Study ID Numbers  ICMJE D4190C00011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MedImmune LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP