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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02611960




Registration number
NCT02611960
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
Scientific 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)
Secondary ID [1] 0 0
MK-3475-122
Secondary ID [2] 0 0
3475-122
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel

Experimental: Pembrolizumab - Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year).

Active comparator: Standard Treatment - 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 on 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.


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Capecitabine
oral tablet

Treatment: Drugs: Gemcitabine
IV infusion

Treatment: Drugs: Docetaxel
IV infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Secondary outcome [1] 0 0
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) Per RECIST 1.1
Timepoint [2] 0 0
Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Secondary outcome [3] 0 0
Duration of Response (DOR) Per RECIST 1.1
Timepoint [3] 0 0
Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
Secondary outcome [4] 0 0
Percentage of Participants Surviving (OS Rate) at 12 Months
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Percentage of Participants Surviving (OS Rate) at 24 Months
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Percentage of Participants With PFS (PFS Rate) at 6 Months
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Percentage of Participants With PFS (PFS Rate) at 12 Months
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Percentage of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [8] 0 0
Up to approximately 73 months
Secondary outcome [9] 0 0
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [9] 0 0
Up to approximately 72 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 standard therapies in this study (i.e., docetaxel, capecitabine, or gemcitabine) may not receive the same therapy if randomized to the Standard Treatment arm. Additionally, participants previously treated in the recurrent/metastatic setting with all 3 standard 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
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* 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 180 days after the last dose of trial treatment for the chemotherapy arm or 120 days after the last dose of trial treatment for the pembrolizumab arm
* Prior therapy with an anti-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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
Accrual to date
Final
233
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

TypeCitations or Other Details
Journal Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Kim ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02611960