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Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Pembrolizumab (MK-3475) in Chinese Participants With Non-Small-Cell Lung Cancer (MK-3475-032/KEYNOTE-032)

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ClinicalTrials.gov Identifier: NCT02835690
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Cycle 1 is 28 days long; subsequent cycles are 21 days long.


Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Biological: Pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Phase I Study Investigating Safety, Tolerability, Pharmacokinetics, and Efficacy of Pembrolizumab (MK-3475) in Chinese Subjects With Non-Small-Cell Lung Cancer
Actual Study Start Date : August 4, 2016
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab 2 mg/kg
Participants receive pembrolizumab 2 mg/kg administered intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations. Cycle 1 is 28 days instead of 21 days.
Biological: Pembrolizumab
IV infusion
Other Name: MK-3475

Experimental: Pembrolizumab 10 mg/kg
Participants receive pembrolizumab 10 mg/kg administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days instead of 21 days.
Biological: Pembrolizumab
IV infusion
Other Name: MK-3475

Experimental: Pembrolizumab 200 mg Fixed Dose
Participants receive pembrolizumab 200 mg fixed dose administered IV Q3W for up to 35 administrations. Cycle 1 is 28 days instead of 21 days.
Biological: Pembrolizumab
IV infusion
Other Name: MK-3475




Primary Outcome Measures :
  1. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]
  2. Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to approximately 2 years ]
  3. Single Dose PK: Area Under the Plasma Concentration Curve from 0-28 Days (AUC0-28 days) of Pembrolizumab [ Time Frame: Cycle 1 (28 days) Day 1: Pre-dose and 0.5, 6, 24, 48, 168, 336, and 504 hours after completion of pembrolizumab infusion ]
  4. Single-Dose PK: Maximum Plasma Concentration (Cmax) of Pembrolizumab [ Time Frame: Cycle 1 (28 days) Day 1: Pre-dose and 0.5, 6, 24, 48, 168, 336, and 504 hours after completion of pembrolizumab infusion ]
  5. Single Dose PK: Time to Cmax (Tmax) of Pembrolizumab [ Time Frame: Cycle 1 (28 days) Day 1: Pre-dose and 0.5, 6, 24, 48, 168, 336, and 504 hours after completion of pembrolizumab infusion ]
  6. Single Dose PK: Apparent Terminal Half-Life (t1/2) of Pembrolizumab [ Time Frame: Cycle 1 (28 days) Day 1: Pre-dose and 0.5, 6, 24, 48, 168, 336, and 504 hours after completion of pembrolizumab infusion ]
  7. Multiple Dose PK: Trough Plasma Concentration (Ctrough) of Pembrolizumab [ Time Frame: Cycle 8 (21 days), Day 1: Pre-dose ]
  8. Multiple Dose PK: AUC0-21day of Pembrolizumab [ Time Frame: Cycle 8 (21 days): Pre-dose and 0.5, 6, 24, 48, 168, 336, and 504 hours after completion of pembrolizumab infusion ]
  9. Multiple Dose PK: Cmax of Pembrolizumab [ Time Frame: Cycle 8 (21 days): Pre-dose and 0.5, 6, 24, 48, 168, 336, and 504 hours after completion of pembrolizumab infusion ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 2 approximately years ]
  2. Duration of Response (DOR) [ Time Frame: Up to 2 approximately years ]
  3. Progression-Free survival (PFS) [ Time Frame: Up to 2 approximately years ]
  4. Overall Survival (OS) [ Time Frame: Up to 2 approximately years ]


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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:

  • Is of the Chinese race (i.e., Chinese descent born in China) and has a Chinese home address.
  • Has a life expectancy of at least 3 months.
  • Has histologically-/cytologically-confirmed, advanced unresectable NSCLC and has measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the site.
  • Has failed established standard medical anti-cancer therapies or has been intolerant to such therapy, or in the opinion of the investigator have been considered ineligible for any form of standard therapy on medical grounds.
  • Has a score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status within 3 days prior to the first dose of study drug.
  • Has adequate organ function.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
  • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.

Exclusion Criteria:

  • Has had chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the first dose of study therapy pembrolizumab, or who has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks earlier.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.
  • Is expected to require any other form of antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC).
  • Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.
  • Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Had prior treatment targeting PD-1:PD-L1 axis or cytotoxic T-lymphocyte-associated protein (CTLA), or was previously randomized in any pembrolizumab study. Examples of such agents include (but are not limited to): Nivolumab (BMS-936558, MDX-1106 or ONO-4538); Pidilizumab (CT-011); AMP-224; BMS-936559 (MDX-1105); MPDL3280A (RG7446); and MEDI4736.
  • Has an active infection requiring systematic therapy.
  • Is positive for Human Immunodeficiency Virus (HIV).
  • Has known active Hepatitis B or C.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.
  • Is at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
  • Is pregnant or breastfeeding, or expecting to conceive or father a child within the projected duration of the study, starting with the screening visit (Visit 1) through 120 days after the last dose of pembrolizumab.

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): NCT02835690


Locations
China
Merck Sharp & Dohme (China) Ltd.
Beijing, China
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02835690     History of Changes
Other Study ID Numbers: 3475-032
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents