D4193C00002: A PHASE III RANDOMIZED, OPEN-LABEL, MULTI-CENTER, GLOBAL STUDY OF MEDI4736 MONOTHERAPY AND MEDI4736 IN COMBINATION WITH TREMELIMUMAB VERSUS STANDARD OF CARE THERAPY IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)”
- Conditions
- -C50 Malignant neoplasm of breast-C14 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxMalignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxMalignant neoplasm of breastC14C50
- Registration Number
- PER-043-15
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method