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 sites109 target enrollmentJanuary 19, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma
Sponsor: ovartis Pharma Services AG
Enrollment: 109
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

January 19, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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