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Clinical Trials List

Protocol NumberCPDR001X2201
NCT Number(ClinicalTrials.gov Identfier)NCT02605967

2015-09-01 - 2021-02-19

Phase II

Not yet recruiting1

Terminated3

ICD-10C11

Malignant neoplasm of nasopharynx

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.

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Hung-Ming Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

11 Terminated

Audit

None

Principal Investigator Pei-Jen Lou Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Audit

None

Condition/Disease

moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma

Objectives

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 NPC. By blocking the interaction between PD-1 and its ligands, PD-L1, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.

Test Drug

PDR001

Active Ingredient

PDR001

Dosage Form

lyophilized powder

Dosage

100 mg/Vial

Endpoints

Efficacy assessments
Tumor assessment per RECIST v1.1 and per irRC

Safety assessments
Incidence and severity of AEs and SAEs, including changes in
laboratory values, vital signs and ECGs

Other assessments
Serum PK parameters and Immunogenicity
Pharmacodynamic assessment on pre- and post- treatment on tumor
and blood samples

Inclution Criteria

Inclusion criteria(selected)
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).

Exclusion Criteria

Exclusion criteria (selected)
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.

The Estimated Number of Participants

  • Taiwan

    32 participants

  • Global

    122 participants

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