Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Completed · Phase 2

Conditions studied: Nasopharyngeal Carcinoma

In brief

The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001 versus investigator's choice of chemotherapy in patients with advanced nasopharyngeal carcinoma (NPC). By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the activation of a T-cell mediated antitumor immune response.

Key facts

Study ID

NCT02605967

Run by

Novartis Pharmaceuticals

People needed

122

Starts

2016-04-20

Expected to finish

2021-02-19

Last updated by the study team

2022-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
• Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
• May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
• 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.
• At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
• 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.
• 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).

You may not qualify if…

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

Where it is running

• Northwest Georgia Oncology Center NWGA Onc - Carrollton — Marietta, Georgia, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• NYU Laura and Isaac Perlmutter Cancer Center Laura & Isaac Perlmutter Ctr — New York, New York, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Novartis Investigative Site — Guangzhou, China
• Novartis Investigative Site — Nice, Alpes Maritimes, France
• Novartis Investigative Site — Villejuif, Villejuif, France
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Kowloon, Hong Kong
• Novartis Investigative Site — Tuenmen, Hong Kong
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Tainan, Taiwan ROC, Taiwan
• Novartis Investigative Site — Kaohsiung City, Taiwan
• Novartis Investigative Site — Taipei, Taiwan
• Novartis Investigative Site — Taoyuan, Taiwan
• Novartis Investigative Site — Songkhla, Hat Yai, Thailand
• Novartis Investigative Site — Bangkok, Thailand
• Novartis Investigative Site — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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