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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05665595
Registration number
NCT05665595
Ethics application status
Date submitted
16/12/2022
Date registered
27/12/2022
Titles & IDs
Public title
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
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Scientific title
A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)
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Secondary ID [1]
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MK-7684A-010
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Secondary ID [2]
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7684A-010
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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:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab/Vibostolimab
Treatment: Other - Pembrolizumab
Experimental: Pembrolizumab/Vibostolimab - Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Active comparator: Pembrolizumab - Adult participants receive 200 mg and adolescent participants =40 kg receive 2 mg/kg (up to a max of 200 mg) pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Treatment: Other: Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Treatment: Other: Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
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Intervention code [1]
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Treatment: Other
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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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Recurrence-Free Survival (RFS)
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Assessment method [1]
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RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator will be reported for all randomized participants.
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Timepoint [1]
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Up to approximately 13 months
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Secondary outcome [1]
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Distant Metastasis-Free Survival (DMFS)
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Assessment method [1]
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DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. The DMFS as assessed by the investigator will be reported for all randomized participants.
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Timepoint [1]
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Up to approximately 68 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 92 months
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Secondary outcome [3]
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Number of Participants Who Experienced at Least One Adverse Event (AE)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 15 months
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Secondary outcome [4]
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Number of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 12 months
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Secondary outcome [5]
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Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
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Assessment method [5]
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The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.
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Timepoint [5]
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Baseline and up to approximately 72 months
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Secondary outcome [6]
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Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
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Assessment method [6]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
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Timepoint [6]
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Baseline and up to approximately 72 months
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Secondary outcome [7]
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Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
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Assessment method [7]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
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Timepoint [7]
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Baseline and up to approximately 72 months
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Eligibility
Key inclusion criteria
* Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
* Has not received any prior systemic therapy for melanoma beyond surgical resection
* Has had no more than 12 weeks between final surgical resection and randomization
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
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Minimum age
12
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
* Has ocular, mucosal, or conjunctival melanoma
* 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 the first dose of study medication
* Has not adequately recovered from major surgical procedure or has ongoing surgical complications
* Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
* Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* 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
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
Active, not 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
19/01/2023
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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
31/03/2031
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Actual
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Sample size
Target
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Accrual to date
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Final
1594
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464) - Blacktown
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Calvary Mater Newcastle-Medical Oncology ( Site 1462) - Waratah
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Melanoma Institute Australia-Clinical Trials Unit ( Site 1450) - Wollstonecraft
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Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
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Cairns Hospital-Clinical Research Unit ( Site 1458) - Cairns
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Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451) - Greenslopes
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Tasman Oncology Research ( Site 1456) - Southport
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Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457) - Adelaide
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Icon Cancer Centre Hobart ( Site 1465) - Hobart
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Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455) - Melbourne
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Recruitment hospital [11]
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One Clinical Research ( Site 1460) - Nedlands
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Recruitment postcode(s) [1]
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2148 - Blacktown
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2298 - Waratah
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2065 - Wollstonecraft
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4029 - Brisbane
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4870 - Cairns
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4120 - Greenslopes
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4215 - Southport
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5000 - Adelaide
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7000 - Hobart
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3000 - Melbourne
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Recruitment outside Australia
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Italy
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State/province [98]
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0
Milano
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Country [99]
0
0
Italy
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State/province [99]
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0
Modena
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Country [100]
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0
Italy
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State/province [100]
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0
Napoli
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Country [101]
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0
Japan
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State/province [101]
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Aichi
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Country [102]
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Japan
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State/province [102]
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0
Hokkaido
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Country [103]
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Japan
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State/province [103]
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Niigata
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Country [104]
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0
Japan
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State/province [104]
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0
Shizuoka
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Country [105]
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0
Japan
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State/province [105]
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Tokyo
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Country [106]
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Japan
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State/province [106]
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Osaka
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Country [107]
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0
Korea, Republic of
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State/province [107]
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Seoul
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Country [108]
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0
New Zealand
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State/province [108]
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Bay Of Plenty
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Country [109]
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0
New Zealand
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State/province [109]
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Canterbury
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Country [110]
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0
New Zealand
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State/province [110]
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0
Manawatu-Wanganui
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Country [111]
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0
New Zealand
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State/province [111]
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Otago
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Country [112]
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0
New Zealand
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State/province [112]
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Auckland
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Country [113]
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Poland
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State/province [113]
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0
Kujawsko-pomorskie
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Country [114]
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0
Poland
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State/province [114]
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0
Malopolskie
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Country [115]
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0
Poland
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State/province [115]
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Mazowieckie
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Country [116]
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0
Poland
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State/province [116]
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0
Podlaskie
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Country [117]
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0
Poland
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State/province [117]
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0
Pomorskie
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Country [118]
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0
Poland
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State/province [118]
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Slaskie
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Country [119]
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0
Poland
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State/province [119]
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0
Swietokrzyskie
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Country [120]
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0
Poland
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State/province [120]
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0
Wielkopolskie
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Country [121]
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0
Poland
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State/province [121]
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0
Zachodniopomorskie
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Country [122]
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0
South Africa
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State/province [122]
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0
Eastern Cape
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Country [123]
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South Africa
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State/province [123]
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0
Gauteng
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Country [124]
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0
South Africa
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State/province [124]
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0
Kwazulu-Natal
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Country [125]
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0
South Africa
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State/province [125]
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Western Cape
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Country [126]
0
0
Spain
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State/province [126]
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Barcelona
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Country [127]
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0
Spain
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State/province [127]
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0
Gipuzkoa
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Country [128]
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Spain
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State/province [128]
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Madrid, Comunidad De
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Country [129]
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0
Spain
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State/province [129]
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Malaga
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Country [130]
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0
Spain
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State/province [130]
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0
Valenciana, Comunitat
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Country [131]
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Spain
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State/province [131]
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Sevilla
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Country [132]
0
0
Sweden
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State/province [132]
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0
Jonkopings Lan
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Country [133]
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Sweden
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State/province [133]
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Stockholms Lan
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Country [134]
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Switzerland
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State/province [134]
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Basel-Stadt
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Country [135]
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Switzerland
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State/province [135]
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Berne
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Country [136]
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Switzerland
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State/province [136]
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Geneve
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Country [137]
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Switzerland
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State/province [137]
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Ticino
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Country [138]
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Switzerland
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State/province [138]
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Vaud
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Country [139]
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Switzerland
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State/province [139]
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Wallis
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Country [140]
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Switzerland
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State/province [140]
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Zurich
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Country [141]
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Switzerland
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State/province [141]
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Sankt Gallen
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Country [142]
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Turkey
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State/province [142]
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Ankara
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Country [143]
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Turkey
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State/province [143]
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Izmir
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Country [144]
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Turkey
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State/province [144]
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Antalya
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Country [145]
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Turkey
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State/province [145]
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Istanbul
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Country [146]
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Turkey
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State/province [146]
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Mersin
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Country [147]
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Turkey
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State/province [147]
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Samsun
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Country [148]
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0
United Kingdom
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State/province [148]
0
0
Cambridgeshire
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Country [149]
0
0
United Kingdom
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State/province [149]
0
0
England
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Country [150]
0
0
United Kingdom
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State/province [150]
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0
London, City Of
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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
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
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Trial website
https://clinicaltrials.gov/study/NCT05665595
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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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0
Medical Director
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Address
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0
Merck Sharp & Dohme LLC
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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0
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Address
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Phone
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Fax
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0
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Email
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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)?
Query!
Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05665595