Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03897881 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
MinorPrimary and study completion dates: Nov 30, 2032 to Nov 21, 2032v18
NotablePrimary and study completion dates: Sep 9, 2029 to Nov 30, 2032
Trial status: Recruiting to Active, Not Recruiting
Study sites: 22 to 23
v17
MinorSecondary endpoints: details revised at 3 of 3 entriesv16
MinorSite contacts updated at 4 of 22 sitesv15
MinorStudy sites: 21 to 22v14
Show 12 earlier versionsHide 12 earlier versions
MinorEnrollment target: 257 to 267v13
MinorStudy sites: 22 to 21v12
NotableTrial status: Active, Not Recruiting to Recruitingv11Show 5 more changesShow less
Enrollment target: 157 to 257
Primary and study completion dates: Sep 29, 2024 to Sep 9, 2029
Interventions: Pembrolizumab (Biological), mRNA-4157 (Biological) to Pembrolizumab (Biological), mRNA-4157 (Drug)
Secondary endpoints: details revised at 3 of 3 entries
Site details revised at 22 of 22 sites
NotablePrimary completion date: Jun 30, 2022 to Sep 29, 2024
Study completion date: Jun 30, 2024 to Sep 29, 2024
v10
MinorRe-verified, no change to tracked fieldsv9
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 150 to confirmed 157
Site details revised at 22 of 22 sites
v8
MinorRe-verified, no change to tracked fieldsv7
NotablePrimary endpoint revised
Eligibility criteria expanded, about 17 words
Secondary endpoints: 4 to 3
Study title revised
v6
NotablePrimary completion date: Dec 2021 to Jun 30, 2022
Study sites: 16 to 22
Study completion date: Dec 2023 to Jun 30, 2024
v5
MinorStudy sites: 17 to 16v4
MinorSite details revised at 1 of 17 sitesv3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 17
Start date changed from estimate of Jul 2019 to Jul 18, 2019
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.