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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/NCT02628067
Registration number
NCT02628067
Ethics application status
Date submitted
9/12/2015
Date registered
11/12/2015
Date last updated
10/05/2024
Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
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Scientific title
A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)
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Secondary ID [1]
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163196
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Secondary ID [2]
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3475-158
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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:
Advanced Cancer
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Anal Carcinoma
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Anal Cancer
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Biliary Cancer
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Cholangiocarcinoma
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Bile Duct Cancer
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Neuroendocrine Tumor
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Carcinoid Tumor
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Endometrial Carcinoma
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Endometrial Cancer
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Cervical Carcinoma
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Cervical Cancer
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Vulvar Carcinoma
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Vulvar Cancer
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Small Cell Lung Carcinoma
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Small Cell Lung Cancer (SCLC)
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Mesothelioma
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Thyroid Carcinoma
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Thyroid Cancer
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Salivary Gland Carcinoma
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Salivary Gland Cancer
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Salivary Cancer
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Parotid Gland Cancer
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Advanced Solid Tumors
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Colorectal Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Lung - Small cell
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Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Thyroid
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Cancer
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Lung - Mesothelioma
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Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
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Head and neck
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Cancer
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Bowel - Anal
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Cancer
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Other cancer types
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - pembrolizumab
Other interventions - pembrolizumab
Experimental: Pembrolizumab 200 mg - Participants will receive pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years of treatment).
Experimental: Pembrolizumab 400 mg - Participants with any advanced solid tumor that has failed at least one line of therapy and is Tumor- Mutational Burden-High (TMB-H), excluding participants with mismatch repair deficient (dMMR/MSI-H) tumors. The dosing regimen for this cohort will be 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to approximately 2 years of treatment).
Other interventions: pembrolizumab
intravenous infusion
Other interventions: pembrolizumab
intravenous infusion
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Intervention code [1]
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Other interventions
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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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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ at any time during the trial. Responses will be determined by independent central radiologic review, with confirmatory assessment as required per RECIST 1.1. Participants with unknown or missing response information will be treated as non-responders. The percentage of participants who experience a CR or PR based on modified RECIST 1.1 will be presented.
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Timepoint [1]
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Up to approximately 10.5 years
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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DOR, defined in the subset of participants with a CR or PR, based on RECIST 1.1 as assessed by independent central radiologic review, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. A Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Participants who are alive, have not progressed, have not initiated new anti-cancer treatment, and have not been determined to be lost to follow-up are considered ongoing responders at the time of analysis.
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Timepoint [1]
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Up to approximately 10.5 years
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Secondary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from allocation to the first documented disease progression according to RECIST 1.1 as assessed by independent central radiologic review, or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions is also considered PD. If a participant does not have a documented date of progression or death, PFS will be censored at the date of the last adequate assessment.
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Timepoint [2]
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Up to approximately 10.5 years
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS is defined as the time from randomization to death due to any cause. OS will be presented. Censoring will be performed using the date of last known contact for those who are alive at the time of analysis.
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Timepoint [3]
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Up to approximately 10.5 years
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Secondary outcome [4]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [4]
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An adverse event (AE) is defined as any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this intervention. The percentage of participants with AEs will be reported.
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Timepoint [4]
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Up to approximately 27 months
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Secondary outcome [5]
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Percentage of Participants who Discontinue Study Intervention due to AEs
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Assessment method [5]
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An AE is defined as any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinue study intervention due to AEs will be reported.
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Timepoint [5]
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Up to approximately 2 years
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Eligibility
Key inclusion criteria
- Histologically or cytologically-documented, advanced solid tumor of one of the following
types:
- Anal Squamous Cell Carcinoma
- Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic
cholangiocarcinoma) except Ampulla of Vater cancers)
- Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix,
small intestine, colon, rectum, or pancreas
- Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
- Cervical Squamous Cell Carcinoma
- Vulvar Squamous Cell Carcinoma
- Small Cell Lung Carcinoma
- Mesothelioma
- Thyroid Carcinoma
- Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
- Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is
Microsatellite Instability (MSI)-High (MSI-H) OR
- Any advanced solid tumor (including Colorectal Carcinoma [CRC]) which is Mismatch
Repair Deficient (dMMR)/MSI-H in participants from mainland China who are of Chinese
descent. (CRC participants will have a histologically proven locally advanced
unresectable or metastatic CRC which is dMMR/MSI-H that has received 2 prior lines of
therapy) OR
- Any advanced solid tumor that has failed at least one line of therapy and is TMB-H
(=10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors.
Note: For participants to be eligible for enrollment they must have failed at least one
line of standard of care systemic therapy (ie, not treatment naïve), with the exception of
CRC participants who must have failed at least 2 lines of standard of care systemic
therapy, as per CRC specific eligibility criteria. Participants must not have melanoma or
NSCLC.
- Progression of tumor or intolerance to therapies known to provide clinical benefit.
There is no limit to the number of prior treatment regimens
- Can supply tumor tissue for study analyses (dependent on tumor type)
- Radiologically-measurable disease
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale within 3 days prior to first dose of pembrolizumab
- Life expectancy of at least 3 months
- Adequate organ function
- Female participants of childbearing potential must be willing to use adequate
contraception during the intervention period and for at least the time needed to
eliminate each study intervention after the last dose of study intervention. and
agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for
the purpose of reproduction during this period. The length of time required to
continue contraception for each study intervention is as follows: MK-3475 (120 days)
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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
- Currently participating and receiving study therapy or has participated in a study of
an investigational agent and received study therapy or used an investigational device
within 4 weeks of the first dose of study treatment
- 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 treatment
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not
recovered from an adverse event caused by mAbs administered more than 4 weeks earlier
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
weeks of study Day 1 or not recovered from adverse events caused by a previously
administered agent
- Known additional malignancy within 2 years prior to enrollment with the exception of
curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the
skin and/or curatively resected in situ cancers
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has known glioblastoma multiforme of the brain stem
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- Active infection requiring systemic therapy
- Known psychiatric or substance abuse disorders that would interfere with the
participant's ability to cooperate with the requirements of the study
- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment
- Previously participated in any other pembrolizumab (MK-3475) study, or received prior
therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1),
anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically
targeting T-cell co-stimulation or checkpoint pathways
- Known history of Human Immunodeficiency Virus (HIV)
- Known active Hepatitis B or C
- Received live vaccine within 30 days of planned start of study treatment
- Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients
- Known history of active tuberculosis (TB, Bacillus tuberculosis)
- Has had an allogenic tissue/solid organ transplant.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
18/12/2015
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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
4/05/2027
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Actual
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Sample size
Target
1609
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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MSD Australia - North Ryde
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Recruitment postcode(s) [1]
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- North Ryde
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Country [2]
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Brazil
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State/province [2]
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Sao Paulo
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Canada
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State/province [3]
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Quebec
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Country [4]
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Chile
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State/province [4]
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Santiago
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Country [5]
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Colombia
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State/province [5]
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Bogota
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Country [6]
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Denmark
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State/province [6]
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Glostrup
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Country [7]
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France
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State/province [7]
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Paris
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Country [8]
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Germany
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State/province [8]
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Haar
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Country [9]
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Israel
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State/province [9]
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Hod Hasharon
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Country [10]
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Italy
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State/province [10]
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Rome
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul
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Mexico
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State/province [12]
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Mexico City
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Country [13]
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Netherlands
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State/province [13]
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Haarlem
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Norway
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State/province [14]
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Drammen
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Country [15]
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Peru
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State/province [15]
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Lima
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Country [16]
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Philippines
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State/province [16]
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Makati
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Country [17]
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Poland
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State/province [17]
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Warsaw
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Country [18]
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Portugal
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State/province [18]
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Paco D'arcos
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Country [19]
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Russian Federation
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State/province [19]
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Moscow
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Country [20]
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South Africa
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State/province [20]
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Midrand
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Country [21]
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Spain
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State/province [21]
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Madrid
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Country [22]
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Taiwan
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State/province [22]
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Taipei
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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
In this study, participants with multiple types of advanced (unresectable and/or metastatic)
solid tumors who have progressed on standard of care therapy will be treated with
pembrolizumab (MK-3475).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02628067
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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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 public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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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/NCT02628067
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