Back to resultsA Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MEDI4736
tremelimumab
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
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.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEDI4736 + tremelimumab
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects reporting adverse events
Number of subjects reporting serious adverse events
Number of subjects experiencing dose-limiting toxicities
Change from Baseline in laboratory evaluations
Change from Baseline in electrocardiograms
Change from Baseline in vital signs
Secondary Outcome Measures
Objective Response Rate
Individual MEDI4736 concentrations
Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736
Disease Control Rate
Duration of Response
Progression Free Survival
Overall Survival
Individual tremelimumab concentrations
MEDI4736 area under the concentration-curve
Tremelimumab area under the concentration-curve
Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02262741
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2014 (Actual)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI4736 + tremelimumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MEDI4736
Intervention Description
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Intervention Type
Biological
Intervention Name(s)
tremelimumab
Intervention Description
Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Primary Outcome Measure Information:
Title
Number of subjects reporting adverse events
Time Frame
Screening through 3 months after the last dose of study medication
Title
Number of subjects reporting serious adverse events
Time Frame
Screening through 3 months after the last dose of study medication
Title
Number of subjects experiencing dose-limiting toxicities
Time Frame
First dose of study medications through 4 weeks after the first dose of study medication
Title
Change from Baseline in laboratory evaluations
Time Frame
Screening through 3 months after the last dose of study medication
Title
Change from Baseline in electrocardiograms
Time Frame
Screening through 3 months through last dose of study medication
Title
Change from Baseline in vital signs
Time Frame
Screening through 3 months after the last dose of study medication
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
Screening through 5 years after the last subject receives the first dose of study medication
Title
Individual MEDI4736 concentrations
Time Frame
First dose of MEDI4736 through 3 months after the last dose of study medication
Title
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
Title
Disease Control Rate
Time Frame
Screening through 5 years after the last subject receives the first dose of study medication
Title
Duration of Response
Time Frame
Screening through 5 years after the last subject receives the first dose of study medication
Title
Progression Free Survival
Time Frame
Screening through 5 years after the last subject receives the first dose of study medication
Title
Overall Survival
Time Frame
Screening through 5 years after the last subject receives the first dose of study medication
Title
Individual tremelimumab concentrations
Time Frame
First dose of tremelimumab through 3 months after the last dose of study medication
Title
MEDI4736 area under the concentration-curve
Time Frame
First dose of MEDI4736 through 3 months after the last dose of study medication
Title
Tremelimumab area under the concentration-curve
Time Frame
First dose of tremelimumb through 3 months after the last dose of study medication
Title
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 Pre-specified Outcome Measures:
Title
Changes in Biomarkers
Description
Evaluate biomarkers that may correlate with clinical activity of MEDI4736 monotherapy and in combination with tremelimumab
Time Frame
Screening through 3 months after the last patient receives the first dose of study medication
Title
Change from Baseline in Patient-Reported Outcomes
Time Frame
Screening through 5 years after the last patient receives the first dose of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MedImmune LLC
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
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