A phase II, open-label, randomized controlled study of PDR001 in patients with moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma who progressed on standard treatment

ovartis Pharma Services AG0 个研究点目标入组 109 人开始时间: 2016年1月19日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1. Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
•2. Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
•3. May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
•4. An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator.
•5. At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
•6. Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline.
•7. Patient must be willing to undergo testing for human immunodeficiency virus (HIV) if not tested within the past 6 months. If HIV+ positive, patient will be eligible if: his/ her CD4+ count = 300/µL; his/her viral load is undetectable; he/she is currently receiving highly active antiretroviral therapy (HAART).
•Other protocol-defined inclusion criteria may apply
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 74

•1. History of severe hypersensitivity reactions to other mAbs
•2. Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
•3. Active HBV or HCV infections requiring therapy.
•4. Prior PD-1- or PD-L1-directed therapy or any therapeutic cancer vaccine.
•5. Patients receiving systemic treatment with any immunosuppressive medication.
•6. Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
•Other protocol-defined exclusion criteria may apply

发起方