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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02611960
Registration number
NCT02611960
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015
Date last updated
13/07/2023
Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
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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)
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Secondary ID [1]
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MK-3475-122
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Secondary ID [2]
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3475-122
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal Neoplasms
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Condition category
Condition code
Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 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.
Other interventions: Pembrolizumab
IV infusion
Treatment: Drugs: Capecitabine
oral tablet
Treatment: Drugs: Gemcitabine
IV infusion
Treatment: Drugs: Docetaxel
IV infusion
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [1]
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Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
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Secondary outcome [1]
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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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Assessment method [1]
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PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [1]
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Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
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Secondary outcome [2]
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Objective Response Rate (ORR) Per RECIST 1.1
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Assessment method [2]
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ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: =30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [2]
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Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
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Secondary outcome [3]
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Duration of Response (DOR) Per RECIST 1.1
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Assessment method [3]
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For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [3]
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Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)
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Secondary outcome [4]
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Percentage of Participants Surviving (OS Rate) at 12 Months
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Assessment method [4]
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OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Percentage of Participants Surviving (OS Rate) at 24 Months
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Assessment method [5]
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OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Percentage of Participants With PFS (PFS Rate) at 6 Months
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Assessment method [6]
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PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Percentage of Participants With PFS (PFS Rate) at 12 Months
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Assessment method [7]
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PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Percentage of Participants Who Experience One or More Adverse Events (AEs)
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Assessment method [8]
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An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm.
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Timepoint [8]
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Up to approximately 73 months
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Secondary outcome [9]
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Percentage of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [9]
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An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm.
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Timepoint [9]
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Up to approximately 72 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2022
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Sample size
Target
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Accrual to date
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Final
233
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study of pembrolizumab (MK-3475) versus standard 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 Overall Survival (OS)
when compared to standard treatment.
With Amendment 7 (effective 2-March-2022), upon study completion, participants will be
discontinued and may be enrolled in an extension study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02611960
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02611960
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