A Phase II Clinical Trial of Single Agent Pembrolizumab (MK-3475) in Subjects with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Who Have Failed Platinum and Cetuximab - Phase II Clinical Trial of MK-3475 in subjects with refractory HNSCC

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 150 人开始时间: 2015年6月16日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•Be greater or equal to 18 years of age on day of signing informed consent
•Have histologically or cytologically-confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
•Be resistant to platinum (either cisplatin or carboplatin) and cetuximab-based therapy. Resistance is defined as tumor progression or recurrence within 6 months of the last dose of platinum and cetuximab therapy in the adjuvant (e.g. with radiation after surgery), primary (e.g. with radiation), recurrent, or metastatic setting. Subject must be resistant to both platinum and cetuximab.
•Have provided tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy.
•Have measurable disease based on RECIST 1.1 as determined by central review.
•Have a performance status of 0 or 1 on the ECOG Performance Scale.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•Has disease that is suitable for local therapy administered with curative intent.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
•Has a known additional malignancy that is progressing or requires active treatment.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
•Has active, non-infectious pneumonitis.
•Has an active infection requiring systemic therapy.
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials.
•Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
•Has known active Hepatitis B or Hepatitis C.
•Has received a live vaccine within 30 days of planned start of study therapy.

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc