Submitted by: Mary Ann Diaz 2016-06-15 00:00:00 Last Updated by: Mary Ann Diaz 2020-09-25 12:36:49


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)

PHRR160616-001275

MK-3475-122, Keynote-122; PFDA: 2016-CT0339; CT.gov: NCT02611960

2016-CT0339

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)

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 standard treatment.
 

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2016-09-26 44 2020-05-26 0000-00-00

Ongoing

Institution Classification Region LTO #
Merck Sharp & Dohme (I.A.) LLC Private Business NCR CDRR-NCR-S-16
Institution Region
Merck Sharp & Dohme (I.A.) LLC NCR
Name E-Mail Institution and Institution Address
Priscila Perez priscila.d.perez@merck.com 26/F Philamlife Tower Paseo De Roxas Makati City
Name E-Mail Institution and Institution Address
Priscila Perez priscila.d.perez@merck.com 26/F Philamlife Tower Paseo De Roxas Makati City
Name Expertise Affiliation
Felycette Gay Martinez-Lapus, MD Medical Oncology Davao Doctors Hospital
Ma. Luisa Abesamis-Tiambeng, MD Medical Oncology Cardinal Santos Medical Center
Ma. Noemi Alsay-Uy, MD Medical Oncology Cebu Doctors' University Hospital
Priscilla B. Caguioa, MD Hematology-Oncology St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

Nasopharyngeal Neoplasms

• 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 ] 
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 RECIST 1.1) [ Time Frame: Up to approximately 2 years ]

 

Completed

  • Australia
  • Canada
  • Hong Kong
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • United States

Clinical Trial

MK-3475-122, Keynote-122; PFDA: 2016-CT0339; CT.gov: NCT02611960

DTN 20160121164730

2016-05-18

0000-00-00

20

20

Unspecified

26 Sep 2016

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
•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 (CNS) metastases and/or carcinomatous meningitis
•History of non -infectious pneumonitis that require 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
*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.
 

Interventional

Biological: Pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA® Drug: Capecitabine oral tablet Other Name: XELODA® Drug: Gemcitabine IV infusion Other Name: GEMZAR® Drug: Docetaxel IV infusion Other Name: TAXOTERE®

• 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.
 
Intervention: Biological: pembrolizumab
 
•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.
 
Interventions:
◦Drug: capecitabine
◦Drug: gemcitabine
◦Drug: docetaxel
 

Date Amendment Classification Reason
2016-08-24 Amendments related to the protocol
2017-04-17 Amendments related to the protocol
2017-11-29 Amendments related to the protocol
2018-03-19 Amendments related to the protocol

Randomized

Open Label

Unspecified

Parallel

Treatment

Phase III

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