vibostolimab (MK-7684)

P1/2, N=146, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | N=90 --> 146

P1/2, N=100, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | N=200 --> 100 | Trial completion date: Apr 2030 --> Aug 2025 | Trial primary completion date: Apr 2030 --> Aug 2025

P1/2, N=315, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 --> Apr 2026 | Trial primary completion date: Apr 2030 --> Apr 2026

P1/2, N=90, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 --> Oct 2025 | Trial primary completion date: Apr 2030 --> Oct 2025

Vibostolimab is a novel anti-TIGIT antibody that completely blocks CD155 binding and induces T-cell activation. From experiments using a mouse tumor model and mouse surrogate anti-TIGIT antibody, we demonstrate direct evidence where it not only activates cytotoxic T cells but also induces the activation of antigen-presenting cells. The clinical relevance of vibostolimab, based on these mechanisms, in combination with pembrolizumab was recently tested in registrational trials.

P1/2, N=315, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=450, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Feb 2039 --> Feb 2032 | Trial primary completion date: Feb 2039 --> Feb 2032

Here we report results from the first three arms: pembrolizumab plus vibostolimab (anti-TIGIT), pembrolizumab plus gebasaxturev (coxsackievirus A21) and pembrolizumab monotherapy. Longer follow-up will provide insight into the incremental benefit of combining neoadjuvant pembrolizumab with other therapies in stage IIIB-D melanoma. ClinicalTrials.gov registration: NCT04303169 .

P1/2, N=450, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting

Background In the multicohort phase 2 KEYVIBE-005 study (NCT05007106), the antitumor activity of vibostolimab (anti-T-cell immunoreceptor with Ig and ITIM domains [TIGIT]) coformulated with pembrolizumab (anti–PD-1; vibostolimab/pembrolizumab) was demonstrated in patients with previously treated advanced mismatch repair–deficient (dMMR) endometrial cancer (cohort B1; n = 40; ORR, 64%) and in patients with previously untreated advanced esophageal cancer treated with vibostolimab/pembrolizumab plus 5-fluorouracil and cisplatin (cohort E; n = 40; ORR, 53%). Ethics Approval The study protocol and all amendments were approved by the institutional review board or ethics committee at each institution. Consent All patients provided written informed consent.

P1/2, N=450, Active, not recruiting, Merck Sharp & Dohme LLC | Phase classification: P2 --> P1/2

These studies will also evaluate coformulated immunotherapy addressing issues that occur with the sequential administration of immunotherapy. The KEYVIBE program will provide further insight into the clinical utility of vibostolimab-based therapy across multiple indications and various stages of disease.