A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
Phase 1
Completed
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Registration Number
- NCT02262741
- Lead Sponsor
- MedImmune LLC
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Number of subjects reporting serious adverse events 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 Number of subjects reporting adverse events Screening through 3 months after the last dose of study medication Change from Baseline in vital signs Screening through 3 months after the last dose of study medication
- Secondary Outcome Measures
Name Time Method 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 Duration of Response Screening through 5 years after the last subject receives the first dose of study medication MEDI4736 area under the concentration-curve First dose of MEDI4736 through 3 months after the last dose of study medication Tremelimumab area under the concentration-curve First dose of tremelimumb through 3 months after the last dose of study medication Progression Free Survival Screening through 5 years after the last subject receives the first dose of study medication Overall Survival Screening through 5 years after the last subject receives the first dose of study medication Individual tremelimumab concentrations First dose of tremelimumab 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 Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab First dose of tremelimumab through 6 months after the last dose of study medication
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the combination of MEDI4736 and tremelimumab in HNSCC treatment?
How does the PD-1/PD-L1 and CTLA-4 dual checkpoint inhibition compare to standard-of-care in recurrent/metastatic HNSCC?
Which biomarkers correlate with response to durvalumab and tremelimumab in head and neck squamous cell carcinoma?
What are the most common adverse events associated with MEDI4736 plus tremelimumab in HNSCC patients?
Are there alternative PD-L1/CTLA-4 combination therapies for HNSCC developed by competitors like Merck or Bristol-Myers Squibb?
Trial Locations
- Locations (1)
Research Site
🇨🇦Toronto, Ontario, Canada
Research Site🇨🇦Toronto, Ontario, Canada