Squamous Cell Carcinoma of the Head and Neck
Conditions
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.
Interventions
BIOLOGICALMEDI4736
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
BIOLOGICALtremelimumab
Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Sponsors
MedImmune LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Individual tremelimumab concentrations | First dose of tremelimumab through 3 months after the last dose of study medication |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Biomarkers | 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 | Screening through 5 years after the last patient receives the first dose of study medication | — |
Countries
Canada, United States
Outcome results
None listed