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Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

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ClinicalTrials.gov Identifier: NCT02611960
Recruitment Status : Active, not recruiting
First Posted : November 23, 2015
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.

The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival (PFS) and overall survival (OS) when compared to SOC treatment.


Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Biological: Pembrolizumab Drug: Capecitabine Drug: Gemcitabine Drug: Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)
Actual Study Start Date : April 18, 2016
Estimated Primary Completion Date : March 5, 2020
Estimated Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle until progressive disease (PD) or unacceptable toxicity or a maximum of up to 35 cycles.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Active Comparator: Standard of Care Chemotherapy
Participants receive capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle OR gemcitabine 1250 mg/m^2 IV Days 1 and 8 of each 3-week cycle OR docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Drug: Capecitabine
oral tablet
Other Name: XELODA®

Drug: Gemcitabine
IV infusion
Other Name: GEMZAR®

Drug: Docetaxel
IV infusion
Other Name: TAXOTERE®




Primary Outcome Measures :
  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 2 years ]
  2. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to approximately 2 years ]
  2. Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 25 months ]
  3. Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to approximately 2 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:

  • Histologically confirmed non-keratinizing differentiated NPC or undifferentiated NPC
  • Metastatic disease or incurable locally recurrent disease
  • Treatment with prior platinum therapy
  • Tumor tissue available for programmed cell death ligand 1 (PD-L1) testing
  • Measurable disease based on RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 180 days after the last dose of study drug
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Disease is suitable for local therapy administered with curative intent
  • Participants previously treated in the recurrent/metastatic setting with any 1 of the 3 SOC therapies in this study (i.e., docetaxel, capecitabine, or gemcitabine) may not receive the same therapy if randomized to the SOC arm. Additionally, participants previously treated in the recurrent/metastatic setting with all 3 SOC therapies are excluded from this study.
  • Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study drug
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Not recovered from adverse events due to therapy more than 4 weeks earlier
  • Prior anti-cancer monoclonal antibody (mAb) therapy within 4 weeks prior to Study Day 1, or not recovered from adverse events
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1
  • Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma
  • Active autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, corticosteroids, or immunosuppressive agents
  • Active central nervous system metastases and/or carcinomatous meningitis
  • History of non-infectious pneumonitis that required steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120-180 days after the last dose of study drug according to local standard of care
  • Prior therapy with an anti-programmed cell death-1 (PD-1) or anti-PD1-L1 or -L2 therapy or previously participated in a Merck pembrolizumab (MK-3475) study
  • Human immunodeficiency virus (HIV) positive
  • Hepatitis B or C positive
  • Live vaccine within 30 days of planned start of study drug

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): NCT02611960


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: NCT02611960     History of Changes
Other Study ID Numbers: 3475-122
MK-3475-122 ( Other Identifier: Merck Protocol Number )
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

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

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

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Capecitabine
Docetaxel
Pembrolizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators