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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Other Name: XELODA®
Other Name: GEMZAR®
Other Name: TAXOTERE®
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 2 years ]
- Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
- Overall Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to approximately 2 years ]
- Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 25 months ]
- Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to approximately 2 years ]
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
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|