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Trial record 1 of 1 for:    NCT02605967
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Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02605967
Recruitment Status : Active, not recruiting
First Posted : November 17, 2015
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE November 17, 2015
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE April 20, 2016
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Progression free survival [ Time Frame: approximately 20 months after FPFV ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02605967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Overall Survival (OS) [ Time Frame: 2 years ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients
  • Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameters area under the curve (AUC)
  • Presence and /or concentration of anti-PDR001 antibodies [ Time Frame: 1 year ]
    Assess immunogenicity serum concentration
  • Overall response rate (ORR) [ Time Frame: 1 year ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients
  • Duration of response (DOR) [ Time Frame: 1 year ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients
  • Time to progression (TTP) [ Time Frame: 1 year ]
    evaluate the anti-tumor activity of PDR001 versus investigator choice of chemotherapy in NPC patients
  • 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
  • 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
  • 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
  • expression of immune-related genes (RNA/protein in tumor sample [ Time Frame: 2 years ]
    assess changes in immune-related gene signature
  • Peripheral, soluble ligands and cytokine levels [ Time Frame: 2 years ]
    assess plasma concentration levels of cytokines interferon-gamma ( IFN-γ) in pg/ml
  • Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameters maximum plasma concentration(Cmax)
  • 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)
  • Composite serum pharmacokinetics (PK) parameters [ Time Frame: 1 year ]
    characterize the pharmacokinetics profiles of PDR001; PK parameters include the elimination half-life (T1/2)
  • 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
  • Peripheral, soluble ligands and cytokine levels [ Time Frame: 2 years ]
    assess plasma concentration levels of cytokines as Interleukin-6 ( IL-6) in pg/ml
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Official Title  ICMJE 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • 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.
  • Drug: Investigator choice of chemotherapy
    commonly used chemotherapy as per investigator's choice
Study Arms  ICMJE
  • Experimental: PDR001 - Investigational drug
    anti-PD1 humanized monoclonal antibody
    Intervention: Drug: PDR001
  • Active Comparator: Chemotherapy
    commonly used chemotherapy as per investigator's choice
    Intervention: Drug: Investigator choice of chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
122
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
114
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   France,   Hong Kong,   Singapore,   Taiwan,   Thailand,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT02605967
Other Study ID Numbers  ICMJE CPDR001X2201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP