Brief Title
Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Official Title
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
Brief Summary
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 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival
Secondary Outcome
Overall Survival (OS)
Condition
Nasopharyngeal Carcinoma
Intervention
PDR001
Study Arms / Comparison Groups
PDR001 - Investigational drug
Description: anti-PD1 humanized monoclonal antibody
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
122
Start Date
April 20, 2016
Completion Date
February 17, 2021
Primary Completion Date
February 16, 2021
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Other protocol-define inclusion/exclusion may apply.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02605967
Organization ID
CPDR001X2201
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
January 2021