None listed
Conditions
Interventions
MEDI4736 monotherapy

10 mg/kg via intravenous (IV) infusion every 2 weeks (q2w) for up to 12 months
(26 doses)
MEDI4736 + tremelimumab combination therapy
MEDI4736: 20 mg/kg via IV infusion every 4 weeks (q4w) fo
Tremelimumab: 1 mg/kg via IV infusion q4w for 4 doses (4 doses total)
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age ≥18 years at the time of screening 2. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. (For patients aged <20 years and enrolling in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.) 3. Histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Patients who refuse radical resection are eligible. 4. Tumor progression or recurrence during or after treatment with 1 regimen for recurrent or metastatic disease that must have contained platinum OR progression within 6 months from multimodality therapy containing platinum (for either locally advanced disease or recurrent/metastatic disease). THERE ARE OTHER CRITERIA PLEASE REFERR TO PROTOCOL
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck not specified in the inclusion criteria, patients with SCCHN of unknown primary, and non-squamous histologies (eg, nasopharynx or salivary gland) 2. Received more than 1 regimen for recurrent or metastatic disease 3. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. Note: Local treatment of isolated lesions for palliative intent is acceptable (eg, local surgery or radiotherapy). 4. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment. Receipt of last dose of an approved (marketed) anticancer therapy chemotherapy, targeted therapy, biologic therapy, mAbs, etc.) within 21 days prior to the first dose of study treatment. If sufficient washout time has not occurred due to the schedule or PK properties of an agent, a longer washout period will be required, as agreed upon by AstraZeneca and the Investigator. THERE ARE OTHER CRITERIA PLEASE REFERR TO PROTOCOL
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Haiti, Hungary, Israel, Italy, Japan, Korea South, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactMaria Mercedes Noya
PHARMACEUTICAL RESEARCH ASSOCIATES PERU SAC
Outcome results
None listed