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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03486873
Registration number
NCT03486873
Ethics application status
Date submitted
29/03/2018
Date registered
3/04/2018
Titles & IDs
Public title
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
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Scientific title
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab
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Secondary ID [1]
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0
MK-3475-587
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Secondary ID [2]
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0
3475-587
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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:
Solid Tumors
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0
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Hematologic Malignancies
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0
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Condition category
Condition code
Cancer
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0
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Standard of Care (SOC)
Treatment: Drugs - Lenvatinib
Experimental: Pembrolizumab 200 mg - Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants.
Experimental: Pembrolizumab 400 mg - Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants.
Experimental: Pembrolizumab 200 mg + SOC: Per Parent Study) - Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle PLUS standard of care (SOC) treatment (or per parent study if there is no SOC) for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC or was used in the parent study protocol if there is no SOC recommendation.
Experimental: Pembrolizumab 400 mg + SOC (Per Parent Study) - Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle PLUS SOC treatment (or per parent study if there is no SOC) for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC or was used in the parent study protocol if there is no SOC recommendation.
Active comparator: SOC (Per Parent Study) - Participants receive the dose matched non-pembrolizumab SOC treatment (e.g. chemotherapy) they were receiving as per parent study protocol.
Experimental: Lenvatinib 20 mg - Participants with body weight (BW)\>60kg receive Lenvatinib 20mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Experimental: Lenvatinib 24 mg - Participants with body weight (BW)\>60 kg receive Lenvatinib 24 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Experimental: Lenvatinib 12 mg - Participants with body weight (BW)\>60 kg receive Lenvatinib 12 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Experimental: Lenvatinib 8 mg - Participants with body weight (BW)\<60 kg receive Lenvatinib 8 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Treatment: Drugs: Pembrolizumab
200 or 400 mg IV infusion
Treatment: Drugs: Standard of Care (SOC)
IV infusion or oral tablets
Treatment: Drugs: Lenvatinib
Oral capsules
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Intervention code [1]
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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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OS is defined as the time from randomization or start of study treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last follow-up.
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Timepoint [1]
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Up to approximately 10 years
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Secondary outcome [1]
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Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study
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Assessment method [1]
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DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response on the parent study until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. The DOR will be presented.
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Timepoint [1]
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Up to approximately 10 years
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Secondary outcome [2]
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Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study
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Assessment method [2]
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DOCR is determined by disease assessment and is defined as the time from the date of complete response (CR) on the parent study until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. The DOCR will be presented.
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Timepoint [2]
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Up to approximately 10 years
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Secondary outcome [3]
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Number of Participants Who Experience Serious Adverse Events (SAEs)
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Assessment method [3]
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A SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience a SAE in this study will be presented.
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Timepoint [3]
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Up to approximately 42 months (Up to 90 days after last dose of study treatment)
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Secondary outcome [4]
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Number of Participants Who Experience Adverse Events of Special Interest (AEOSI)
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Assessment method [4]
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AEOSI for this study include selected preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 20.1 for the following higher-level terms: Pneumonitis, Colitis, Hepatitis, Nephritis, Adrenal Insufficiency, Hypophysitis, Hyperthyroidism, Hypothyroidism, Thyroiditis, Type 1 Diabetes Mellitus, Severe Skin Reactions Including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): or If grade 3 or higher, Uveitis, Pancreatitis, Myositis, Guillain-Barre Syndrome, Myocarditis, Encephalitis, Sarcoidosis, Infusion Reactions and Myasthenic Syndrome. The number of participants who experience an AEOSI in this study will be presented.
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Timepoint [4]
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Up to approximately 40 months (Up to 30 days after last dose of study treatment)
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Secondary outcome [5]
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Number of Participants Who Experience Clinically Significant Adverse Events (CSAE)
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Assessment method [5]
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CSAE are AEs associated with lenvatinib treatment and include selected preferred terms from the lenvatinib CSAE preferred term list document. The number of participants who experience an CSAE in this study will be presented.
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Timepoint [5]
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Up to approximately 40 months (Up to 30 days after last dose of study treatment)
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Secondary outcome [6]
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Number of Participants Who Experience Events of Clinical Interest (ECI)
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Assessment method [6]
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ECIs for this study include: 1) An overdose of Sponsor's product, that is not associated with clinical symptoms or abnormal laboratory results or 2) An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is =3X the upper limit of normal (ULN) and an elevated total bilirubin lab value that is =2X ULN and, at the same time, an alkaline phosphatase lab value that is \<2X ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. The number of participants who experience an ECI in this study will be presented.
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Timepoint [6]
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Up to approximately 40 months (Up to 30 days after last dose of study treatment)
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Secondary outcome [7]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [7]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
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Timepoint [7]
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Up to approximately 39 months
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Eligibility
Key inclusion criteria
* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.
Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Demonstrates adequate organ function.
* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and =1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for =120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.
Additional eligibility criteria for participants who enter dosing with Lenvatinib:
* Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications.
* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
* Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for =4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.
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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
-There are no exclusion criteria to participate in MK-3475-587.
Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
* Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients.
* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
* Has hepatic decompensation (Child-Pugh score >6 [class B and C]).
* Has uncontrolled thyroid dysfunction.
* Has uncontrolled diabetes mellitus.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Additional exclusion criteria for participants who enter dosing with Lenvatinib:
* Has had major surgery within 3 weeks prior to first dose of study intervention(s).
* Has preexisting =Grade 3 gastrointestinal or non-gastrointestinal fistula.
* Has urine protein =1 g/24 hours.
* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to >480 ms.
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.
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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 3
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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
21/08/2018
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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
4/08/2043
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Actual
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Sample size
Target
3500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Chris OBrien Lifehouse ( Site 3003) - Camperdown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016) - Camperdown
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Liverpool Hospital-Medical Oncology ( Site 3021) - Liverpool
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Macquarie University ( Site 3010) - Macquarie University
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Recruitment hospital [5]
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Mater Hospital Sydney ( Site 3007) - North Sydney
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Recruitment hospital [6]
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Orange Hospital-Clinical Trials Unit ( Site 3027) - Orange
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Recruitment hospital [7]
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Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3020) - Port Macquarie
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Recruitment hospital [8]
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Royal North Shore Hospital-Medical Oncology Clinical Trials ( Site 3025) - St Leonards
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Recruitment hospital [9]
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Calvary Mater Newcastle ( Site 3005) - Waratah
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Westmead Hospital ( Site 3000) - Westmead
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Recruitment hospital [11]
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Melanoma Institute Australia ( Site 3001) - Wollstonecraft
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Recruitment hospital [12]
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Mater Misericordiae Limited-Medical Oncology ( Site 3019) - Brisbane
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Recruitment hospital [13]
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Gallipoli Medical Research Ltd ( Site 3011) - Brisbane
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Recruitment hospital [14]
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Royal Brisbane and Women s Hospital ( Site 3009) - Herston
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Recruitment hospital [15]
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Tasman Oncology Research Pty Ltd ( Site 3012) - Southport
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Recruitment hospital [16]
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The Townsville Hospital ( Site 3017) - Townsville
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Recruitment hospital [17]
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Princess Alexandra Hospital ( Site 3002) - Woolloongabba
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Recruitment hospital [18]
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Royal Adelaide Hospital ( Site 3014) - Adelaide
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Recruitment hospital [19]
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The Queen Elizabeth Hospital ( Site 3026) - Woodville
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Recruitment hospital [20]
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Monash Health ( Site 3015) - Clayton
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Recruitment hospital [21]
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Austin Health-Austin Hospital ( Site 3004) - Heidelberg
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Recruitment hospital [22]
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Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3008) - Melbourne
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Recruitment hospital [23]
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St Vincent's Hospital-Oncology Clinical Trials ( Site 3018) - Melbourne
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Recruitment hospital [24]
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Western Health-Sunshine & Footscray Hospitals ( Site 3023) - St Albans
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Recruitment hospital [25]
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Ballarat Oncology & Haematology Services ( Site 3022) - Wendouree
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Recruitment hospital [26]
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Sir Charles Gairdner Hospital ( Site 3006) - Nedlands
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Recruitment hospital [27]
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St John of God Subiaco Hospital ( Site 3013) - Subiaco
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2170 - Liverpool
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2109 - Macquarie University
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Recruitment postcode(s) [4]
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2060 - North Sydney
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Recruitment postcode(s) [5]
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2800 - Orange
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Recruitment postcode(s) [6]
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2444 - Port Macquarie
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Recruitment postcode(s) [7]
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2065 - St Leonards
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Recruitment postcode(s) [8]
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2298 - Waratah
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment postcode(s) [10]
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2065 - Wollstonecraft
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Recruitment postcode(s) [11]
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4101 - Brisbane
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Recruitment postcode(s) [12]
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4120 - Brisbane
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Recruitment postcode(s) [13]
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4029 - Herston
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Recruitment postcode(s) [14]
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4215 - Southport
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Recruitment postcode(s) [15]
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4814 - Townsville
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Recruitment postcode(s) [16]
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4102 - Woolloongabba
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Recruitment postcode(s) [17]
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5000 - Adelaide
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Recruitment postcode(s) [18]
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5011 - Woodville
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Recruitment postcode(s) [19]
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3168 - Clayton
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Recruitment postcode(s) [20]
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3084 - Heidelberg
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Recruitment postcode(s) [21]
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3000 - Melbourne
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Recruitment postcode(s) [22]
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3065 - Melbourne
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Recruitment postcode(s) [23]
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3021 - St Albans
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Recruitment postcode(s) [24]
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3355 - Wendouree
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Recruitment postcode(s) [25]
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6009 - Nedlands
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Recruitment postcode(s) [26]
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6008 - Subiaco
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Recruitment outside Australia
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Nevada
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Dakota
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Tennessee
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0
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0
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Texas
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0
0
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0
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Virginia
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0
0
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0
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Washington
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0
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Argentina
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State/province [30]
0
0
Buenos Aires
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0
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Argentina
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State/province [31]
0
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Rio Negro
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0
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Argentina
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State/province [32]
0
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Santa Fe
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0
0
Argentina
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State/province [33]
0
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Cordoba
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0
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Argentina
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0
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La Rioja
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0
0
Argentina
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State/province [35]
0
0
Tucuman
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0
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Austria
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State/province [36]
0
0
Oberosterreich
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0
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Austria
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0
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Steiermark
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0
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Austria
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State/province [38]
0
0
Tirol
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Country [39]
0
0
Austria
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State/province [39]
0
0
Salzburg
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Wien
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Antwerpen
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Bruxelles-Capitale, Region De
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Oost-Vlaanderen
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Vlaams-Brabant
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Namur
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Ceara
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Minas Gerais
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Rio Grande Do Sul
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Santa Catarina
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Sao Paulo
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
Rio de Janeiro
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Alberta
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Ontario
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Quebec
Query!
Country [55]
0
0
Chile
Query!
State/province [55]
0
0
Araucania
Query!
Country [56]
0
0
Chile
Query!
State/province [56]
0
0
Region M. De Santiago
Query!
Country [57]
0
0
Chile
Query!
State/province [57]
0
0
Valparaiso
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Anhui
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Beijing
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Chongqing
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Fujian
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Guangdong
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Heilongjiang
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Hubei
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Hunan
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Jiangsu
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Jilin
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Shaanxi
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Shanghai
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Sichuan
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Tianjin
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Zhejiang
Query!
Country [73]
0
0
Colombia
Query!
State/province [73]
0
0
Antioquia
Query!
Country [74]
0
0
Colombia
Query!
State/province [74]
0
0
Cordoba
Query!
Country [75]
0
0
Colombia
Query!
State/province [75]
0
0
Distrito Capital De Bogota
Query!
Country [76]
0
0
Colombia
Query!
State/province [76]
0
0
Valle Del Cauca
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Brno-mesto
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Olomoucky Kraj
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Praha 4
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Praha 5
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Olomouc
Query!
Country [82]
0
0
Denmark
Query!
State/province [82]
0
0
Syddanmark
Query!
Country [83]
0
0
Estonia
Query!
State/province [83]
0
0
Tartumaa
Query!
Country [84]
0
0
Finland
Query!
State/province [84]
0
0
Pirkanmaa
Query!
Country [85]
0
0
Finland
Query!
State/province [85]
0
0
Varsinais-Suomi
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Alpes-Maritimes
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Alsace
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Aquitaine
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Auvergne
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Bouches-du-Rhone
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Cote-d Or
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Doubs
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Finistere
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Gironde
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Haute-Garonne
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Hauts-de-Seine
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Ile-de-France
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Ille-et-Vilaine
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Indre-et-Loire
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Loire-Atlantique
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Lorraine
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Nord
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Puy-de-Dome
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Rhone-Alpes
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Rhone
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Sarthe
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Seine-Saint-Denis
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Val-de-Marne
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Paris
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Baden-Wurttemberg
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Bayern
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Hessen
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Niedersachsen
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Nordrhein-Westfalen
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Saarland
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Sachsen
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Schleswig-Holstein
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Thuringen
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Berlin
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Hamburg
Query!
Country [121]
0
0
Greece
Query!
State/province [121]
0
0
Attiki
Query!
Country [122]
0
0
Guatemala
Query!
State/province [122]
0
0
Guatemala
Query!
Country [123]
0
0
Hong Kong
Query!
State/province [123]
0
0
Hksar
Query!
Country [124]
0
0
Hungary
Query!
State/province [124]
0
0
Bekes
Query!
Country [125]
0
0
Hungary
Query!
State/province [125]
0
0
Borsod-Abauj-Zemplen
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Fejer
Query!
Country [127]
0
0
Hungary
Query!
State/province [127]
0
0
Jasz-Nagykun-Szolnok
Query!
Country [128]
0
0
Hungary
Query!
State/province [128]
0
0
Pest
Query!
Country [129]
0
0
Hungary
Query!
State/province [129]
0
0
Vas
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Veszprem
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Budapest
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Debrecen
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Kaposvar
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Zalaegerszeg
Query!
Country [135]
0
0
Ireland
Query!
State/province [135]
0
0
Leinster
Query!
Country [136]
0
0
Ireland
Query!
State/province [136]
0
0
Dublin
Query!
Country [137]
0
0
Israel
Query!
State/province [137]
0
0
Haifa
Query!
Country [138]
0
0
Israel
Query!
State/province [138]
0
0
Jerusalem
Query!
Country [139]
0
0
Israel
Query!
State/province [139]
0
0
Petah-Tikva
Query!
Country [140]
0
0
Israel
Query!
State/province [140]
0
0
Ramat Gan
Query!
Country [141]
0
0
Israel
Query!
State/province [141]
0
0
Tel Aviv
Query!
Country [142]
0
0
Israel
Query!
State/province [142]
0
0
Zerifin
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Lazio
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Milano
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Piemonte
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Pordenone
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Torino
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Umbria
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Veneto
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Bergamo
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Brescia
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Genova
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Napoli
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Parma
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Roma
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Siena
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Terni
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Aichi
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Chiba
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Ehime
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Fukuoka
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Hokkaido
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Hyogo
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Ishikawa
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Kagawa
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Kanagawa
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Miyagi
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Nara
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Okayama
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Okinawa
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Osaka
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Saitama
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Shizuoka
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Tochigi
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Tokyo
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Yamaguchi
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Gifu
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Hiroshima
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Kochi
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Wakayama
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Chungbuk
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Jeonranamdo
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Kyonggi-do
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Seoul
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Taegu-Kwangyokshi
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Taejon-Kwangyokshi
Query!
Country [187]
0
0
Latvia
Query!
State/province [187]
0
0
Liepaja
Query!
Country [188]
0
0
Latvia
Query!
State/province [188]
0
0
Riga
Query!
Country [189]
0
0
Lithuania
Query!
State/province [189]
0
0
Klaipedos Miestas
Query!
Country [190]
0
0
Lithuania
Query!
State/province [190]
0
0
Vilniaus Miestas
Query!
Country [191]
0
0
Lithuania
Query!
State/province [191]
0
0
Vilnius
Query!
Country [192]
0
0
Malaysia
Query!
State/province [192]
0
0
Pahang
Query!
Country [193]
0
0
Malaysia
Query!
State/province [193]
0
0
Pulau Pinang
Query!
Country [194]
0
0
Malaysia
Query!
State/province [194]
0
0
Kuala Lumpur
Query!
Country [195]
0
0
Mexico
Query!
State/province [195]
0
0
Distrito Federal
Query!
Country [196]
0
0
Mexico
Query!
State/province [196]
0
0
Nuevo Leon
Query!
Country [197]
0
0
Mexico
Query!
State/province [197]
0
0
Oaxaca
Query!
Country [198]
0
0
Mexico
Query!
State/province [198]
0
0
Yucatan
Query!
Country [199]
0
0
Mexico
Query!
State/province [199]
0
0
Mexico City
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Gelderland
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Noord-Holland
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Zuid-Holland
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Groningen
Query!
Country [204]
0
0
New Zealand
Query!
State/province [204]
0
0
Canterbury
Query!
Country [205]
0
0
New Zealand
Query!
State/province [205]
0
0
Waikato
Query!
Country [206]
0
0
New Zealand
Query!
State/province [206]
0
0
Auckland
Query!
Country [207]
0
0
New Zealand
Query!
State/province [207]
0
0
Wellington
Query!
Country [208]
0
0
Norway
Query!
State/province [208]
0
0
Vestfold
Query!
Country [209]
0
0
Norway
Query!
State/province [209]
0
0
Oslo
Query!
Country [210]
0
0
Peru
Query!
State/province [210]
0
0
Lima
Query!
Country [211]
0
0
Philippines
Query!
State/province [211]
0
0
National Capital Region
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Kujawsko-pomorskie
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Lodzkie
Query!
Country [214]
0
0
Poland
Query!
State/province [214]
0
0
Malopolskie
Query!
Country [215]
0
0
Poland
Query!
State/province [215]
0
0
Mazowieckie
Query!
Country [216]
0
0
Poland
Query!
State/province [216]
0
0
Opolskie
Query!
Country [217]
0
0
Poland
Query!
State/province [217]
0
0
Podlaskie
Query!
Country [218]
0
0
Poland
Query!
State/province [218]
0
0
Wielkopolskie
Query!
Country [219]
0
0
Poland
Query!
State/province [219]
0
0
Zachodniopomorskie
Query!
Country [220]
0
0
Portugal
Query!
State/province [220]
0
0
Lisboa
Query!
Country [221]
0
0
Portugal
Query!
State/province [221]
0
0
Porto
Query!
Country [222]
0
0
Puerto Rico
Query!
State/province [222]
0
0
Ponce
Query!
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0
Puerto Rico
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State/province [223]
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San Juan
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Romania
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Suceava
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Russian Federation
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Altayskiy Kray
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Country [226]
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Russian Federation
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Baskortostan, Respublika
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Country [227]
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Russian Federation
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State/province [227]
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Belgorodskaya Oblast
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Russian Federation
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Ivanovskaya Oblast
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Russian Federation
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Leningradskaya Oblast
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Russian Federation
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Mordoviya, Respublika
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Country [231]
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Russian Federation
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Moskva
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Stavropol Skiy Kray
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Russian Federation
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Tatarstan, Respublika
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Country [235]
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Russian Federation
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Tomskaya Oblast
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Russian Federation
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State/province [236]
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Tyumenskaya Oblast
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Russian Federation
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Udmurtskaya Respublika
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Singapore
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Central Singapore
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Singapore
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South West
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South Africa
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Gauteng
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South Africa
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Limpopo
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South Africa
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Western Cape
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Spain
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Andalucia
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Spain
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State/province [244]
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Asturias
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Spain
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Baleares
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Cataluna
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Spain
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La Coruna
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Spain
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Las Palmas
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Tarragona
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Spain
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Valenciana, Comunitat
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Spain
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Valencia
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Spain
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Alicante
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Spain
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Jaen
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Spain
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Sevilla
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Spain
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Zaragoza
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Sweden
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Stockholms Lan
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Sweden
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Uppsala Lan
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Sweden
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Vasterbottens Lan
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Sweden
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Vastra Gotalands Lan
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Switzerland
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Basel-Stadt
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Switzerland
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Geneve
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Switzerland
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Zurich
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Country [273]
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Thailand
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Krung Thep Maha Nakhon
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Turkey
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Istanbul
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Country [275]
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Turkey
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Adana
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Country [276]
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Turkey
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Ankara
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Turkey
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Antalya
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Country [278]
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Turkey
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Edirne
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Malatya
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Kharkivska Oblast
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Ukraine
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Kirovohradska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Lvivska Oblast
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Ukraine
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Odeska Oblast
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Ukraine
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Sumska Oblast
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Ukraine
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Vinnytska Oblast
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Ukraine
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Zakarpatska Oblast
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Ukraine
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Zaporizka Oblast
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United Kingdom
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Aberdeen City
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United Kingdom
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Edinburgh, City Of
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United Kingdom
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England
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United Kingdom
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Essex
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Country [297]
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United Kingdom
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Glasgow City
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United Kingdom
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Lancashire
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United Kingdom
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London, City Of
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United Kingdom
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Northern Ireland
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United Kingdom
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Nottinghamshire
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United Kingdom
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Leeds
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United Kingdom
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Sutton
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United Kingdom
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Wolverhampton
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.
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Trial website
https://clinicaltrials.gov/study/NCT03486873
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Trial related presentations / publications
Robert C, Carlino MS, McNeil C, Ribas A, Grob JJ, Schachter J, Nyakas M, Kee D, Petrella TM, Blaustein A, Lotem M, Arance A, Daud AI, Hamid O, Larkin J, Anderson J, Krepler C, Grebennik D, Long GV. Seven-Year Follow-Up of the Phase III KEYNOTE-006 Study: Pembrolizumab Versus Ipilimumab in Advanced Melanoma. J Clin Oncol. 2023 Aug 20;41(24):3998-4003. doi: 10.1200/JCO.22.01599. Epub 2023 Jun 22.
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Public notes
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Contacts
Principal investigator
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0
Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Toll Free Number
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Phone
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0
1-888-577-8839
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Robert C, Carlino MS, McNeil C, Ribas A, Grob JJ, ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT03486873