Merck Discontinues KeyVibe-010 Trial of Vibostolimab/Pembrolizumab in Resected High-Risk Melanoma

Source: OncLive, May 2024

The phase 3 KeyVibe-010 trial (NCT05665595) evaluating the combination of adjuvant vibostolimab (MK-7684A) and pembrolizumab (Keytruda) vs pembrolizumab alone in patients with resected high-risk stage IIB, IIC, III, and IV melanoma has been discontinued.

During a preplanned analysis of the anti-TIGIT antibody and anti–PD-1 combination, data showed that the primary end point of recurrence-free survival (RFS) met the prespecified futility criteria in the randomized, double-blind trial. However, the high rate of discontinuation of all adjuvant therapy by patients in the investigational arm compared with the pembrolizumab-only arm made it highly unlikely that the trial would achieve a statistically significant improvement in RFS for patients.

These discontinuations in the combination arm were due to immune-mediated adverse effects, and an independent data monitoring committee recommended that Merck unblind the study. Following this recommendation, Merck will be unblinding the study treatment arms and recommending that patients who were receiving the vibostolimab and pembrolizumab combination be offered the option to be treated with pembrolizumab monotherapy.
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