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

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ClinicalTrials.gov Identifier: NCT02605967
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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


Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: PDR001 Drug: Investigator choice of chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 20, 2016
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PDR001 - Investigational drug
anti-PD1 humanized monoclonal antibody
Drug: PDR001
PDR001 is a humanized anti-PD-1 IgG4 antibody which blocks the binding of PD1 to its ligands PD-L1 and PD-L2.

Active Comparator: Chemotherapy
commonly used chemotherapy as per investigator's choice
Drug: Investigator choice of chemotherapy
commonly used chemotherapy as per investigator's choice




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: approximately 20 months after FPFV ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 years ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients

  2. Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameters area under the curve (AUC)

  3. Presence and /or concentration of anti-PDR001 antibodies [ Time Frame: 1 year ]
    Assess immunogenicity serum concentration

  4. Overall response rate (ORR) [ Time Frame: 1 year ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients

  5. Duration of response (DOR) [ Time Frame: 1 year ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients

  6. Time to progression (TTP) [ Time Frame: 1 year ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients

  7. immune related progression free survival (irPFS) using central assessment [ Time Frame: 2 years ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients

  8. serum concentration vs.time profiles [ Time Frame: 1 year ]
    serum concentration of PDR001 on D1,D8,D15,D29,D36,D43,D57,D58,D64,D71,D85,D140

  9. Potential associations between expression of PD-L1, CD8 and other immunological markers with anti-tumor activity [ Time Frame: 2 years ]
    assess changes in expression of immunological markers such as CD8 and PD-L1 in tumor biopsies

  10. expression of immune-related genes (RNA/protein in tumor sample [ Time Frame: 2 years ]
    assess changes in immune-related gene signature

  11. Peripheral, soluble ligands and cytokine levels [ Time Frame: 2 years ]
    assess plasma concentration levels of cytokines interferon-gamma ( IFN-γ) in pg/ml

  12. Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameters maximum plasma concentration(Cmax)

  13. Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameter as the time to reach maximum peak plasma (Tmax)

  14. Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameters include the elimination half-life (T1/2)

  15. Peripheral, soluble ligands and cytokine levels [ Time Frame: 2 years ]
    assess plasma concentration levels of cytokines as tumor necrosis factor-alpha (TNF-α) in pg/ml

  16. Peripheral, soluble ligands and cytokine levels [ Time Frame: 2 years ]
    assess plasma concentration levels of cytokines as Interleukin-6 ( IL-6) in pg/ml



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605967


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

Locations
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United States, Georgia
Novartis Investigative Site Completed
Marietta, Georgia, United States, 30060
United States, Michigan
Novartis Investigative Site Active, not recruiting
Detroit, Michigan, United States, 48201
United States, New York
NYU Laura and Isaac Perlmutter Cancer Center Laura & Isaac Perlmutter Ctr Recruiting
New York, New York, United States, 10016
Principal Investigator: Zujun Li         
United States, Virginia
Novartis Investigative Site Active, not recruiting
Fairfax, Virginia, United States, 22031
China
Novartis Investigative Site Active, not recruiting
Guangzhou, China, 510060
France
Novartis Investigative Site Active, not recruiting
Nice Cedex 2, Alpes Maritimes, France, 06189
Novartis Investigative Site Active, not recruiting
Villejuif Cedex, France, 94805
Hong Kong
Novartis Investigative Site Active, not recruiting
Hong Kong, Hong Kong
Novartis Investigative Site Active, not recruiting
Kowloon, Hong Kong
Novartis Investigative Site Active, not recruiting
Tuen Mun, Hong Kong
Singapore
Novartis Investigative Site Active, not recruiting
Singapore, Singapore, 169610
Taiwan
Novartis Investigative Site Active, not recruiting
Tainan, Taiwan ROC, Taiwan, 70403
Novartis Investigative Site Active, not recruiting
Kaohsiung City, Taiwan, 83301
Novartis Investigative Site Completed
Taipei, Taiwan, 10002
Novartis Investigative Site Active, not recruiting
Taoyuan, Taiwan, 33305
Thailand
Novartis Investigative Site Active, not recruiting
Songkhla, Hat Yai, Thailand, 90110
Novartis Investigative Site Completed
Bangkok, Thailand, 10330
Novartis Investigative Site Active, not recruiting
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02605967     History of Changes
Other Study ID Numbers: CPDR001X2201
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PDR001,
nasopharyngeal cancer,
moderately differentiated/undifferentiated,
locally advanced,
recurrent or metastatic NPC,
after first- line platinum-based therapy

Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases