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.
With Amendment 4, participants will discontinue treatment with pembrolizumab/vibostolimab. The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 06-Mar-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 192 participants enrolled after the primary completion date and were analyzed in the End of Trial analysis with a data cut-off of 24-Sep-2025 (Study Completion Date).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,594
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
Recurrence-Free Survival (RFS)
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 is presented for all randomized participants. Protocol pre-specified final analysis for this outcome measure was conducted with the primary completion data cut-off.
Time frame: Up to approximately 13 months
Number of Participants Who Experienced At Least One or More Adverse Events (AE)
An adverse event (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 experienced an AE is presented.
Time frame: Up to approximately 20 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An adverse event (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 discontinued study treatment due to an AE is presented.
Time frame: Up to approximately 18 months
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Moores Cancer Center ( Site 0116)
La Jolla, California, United States
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
Los Angeles, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
Los Angeles, California, United States
California Pacific Medical Center - Pacific Campus ( Site 0111)
San Francisco, California, United States
UCSF Medical Center at Mission Bay ( Site 0130)
San Francisco, California, United States
The Melanoma & Skin Cancer Institute ( Site 0120)
Englewood, Colorado, United States
Georgetown University Medical Center ( Site 0144)
Washington D.C., District of Columbia, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
Miami, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
Tampa, Florida, United States
Northwestern Memorial Hospital ( Site 0109)
Chicago, Illinois, United States
...and 195 more locations