A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
1 other identifier
interventional
71
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2014
Typical duration for phase_1
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 13, 2014
CompletedStudy Start
First participant enrolled
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2017
CompletedOctober 23, 2017
October 1, 2017
2.9 years
October 2, 2014
October 20, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
Number of subjects reporting adverse events
Screening through 3 months after the last dose of study medication
Number of subjects reporting serious adverse events
Screening through 3 months after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
First dose of study medications through 4 weeks after the first dose of study medication
Change from Baseline in laboratory evaluations
Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiograms
Screening through 3 months through last dose of study medication
Change from Baseline in vital signs
Screening through 3 months after the last dose of study medication
Secondary Outcomes (11)
Objective Response Rate
Screening through 5 years after the last subject receives the first dose of study medication
Individual MEDI4736 concentrations
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
First dose of MEDI4736 through 6 months after the last dose of study medication
Disease Control Rate
Screening through 5 years after the last subject receives the first dose of study medication
Duration of Response
Screening through 5 years after the last subject receives the first dose of study medication
- +6 more secondary outcomes
Other Outcomes (2)
Changes in Biomarkers
Screening through 3 months after the last patient receives the first dose of study medication
Change from Baseline in Patient-Reported Outcomes
Screening through 5 years after the last patient receives the first dose of study medication
Study Arms (1)
MEDI4736 + tremelimumab
EXPERIMENTALInterventions
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Eligibility Criteria
You may qualify if:
- Male and female subjects
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (23)
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
La Jolla, California, 92093, United States
Research Site
Los Angeles, California, 90025, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
New Haven, Connecticut, 06520, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Fairway, Kansas, 66205, United States
Research Site
New Orleans, Louisiana, 70112, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Minneapolis, Minnesota, 55455, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10065, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
Philadelphia, Pennsylvania, 19111, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
London, Ontario, N6A 4L6, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Algazi A, Papadopoulos KP, Tsai F, Hansen AR, Angra N, Das M, Sheth S, Siu LL. Safety and clinical activity of durvalumab combined with tremelimumab in recurrent/metastatic head and neck squamous cell carcinoma: a multicenter phase I study. ESMO Open. 2024 Aug;9(8):103646. doi: 10.1016/j.esmoop.2024.103646. Epub 2024 Jul 23.
PMID: 39043009DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MedImmune LLC
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 13, 2014
Study Start
October 15, 2014
Primary Completion
September 21, 2017
Study Completion
September 21, 2017
Last Updated
October 23, 2017
Record last verified: 2017-10