^
    13d
    KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov)
    P1/2, N=335, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed
    Trial completion
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • vibostolimab (MK-7684) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A)
    8ms
    KEYMAKER-U02 Substudy 02C: Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (clinicaltrials.gov)
    P1/2, N=146, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | N=90 --> 146
    Trial completion • Enrollment change
    |
    Vesanoid (tretinoin) • vibostolimab (MK-7684) • Cavatak (gebasaxturev) • MK-4830 • favezelimab/pembrolizumab (MK-4280A)
    9ms
    KEYMAKER-U02 Substudy 02A: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (clinicaltrials.gov)
    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
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Vesanoid (tretinoin) • quavonlimab (MK-1308) • vibostolimab (MK-7684)
    10ms
    KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov)
    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
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • vibostolimab (MK-7684) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A)
    10ms
    KEYMAKER-U02 Substudy 02C: Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (clinicaltrials.gov)
    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
    Trial completion date • Trial primary completion date
    |
    Vesanoid (tretinoin) • vibostolimab (MK-7684) • Cavatak (gebasaxturev) • MK-4830 • favezelimab/pembrolizumab (MK-4280A)
    10ms
    Pharmacological and structural characterization of vibostolimab, a novel anti-TIGIT blocking antibody for cancer immunotherapy. (PubMed, J Immunother Cancer)
    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.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • IL2 (Interleukin 2) • PVR (PVR Cell Adhesion Molecule)
    |
    Keytruda (pembrolizumab) • tiragolumab (RG6058) • vibostolimab (MK-7684)
    11ms
    KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov)
    P1/2, N=315, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • vibostolimab (MK-7684) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A)
    1year
    KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (clinicaltrials.gov)
    P1/2, N=450, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Feb 2039 --> Feb 2032 | Trial primary completion date: Feb 2039 --> Feb 2032
    Trial completion date • Trial primary completion date
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402) • ifinatamab deruxtecan (DS-7300) • vibostolimab (MK-7684) • MK-0482 • MK-4830
    over1year
    Neoadjuvant anti-PD-1 alone or in combination with anti-TIGIT or an oncolytic virus in resectable stage IIIB-D melanoma: a phase 1/2 trial. (PubMed, Nat Med)
    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 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Keytruda (pembrolizumab) • vibostolimab (MK-7684) • Cavatak (gebasaxturev)
    over1year
    KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (clinicaltrials.gov)
    P1/2, N=450, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402) • ifinatamab deruxtecan (DS-7300) • vibostolimab (MK-7684) • MK-0482 • MK-4830
    over1year
    Association of biomarkers with response to vibostolimab coformulated with pembrolizumab in 2 cohorts of the phase 2 KEYVIBE-005 study (SITC 2024)
    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.
    P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
    over1year
    KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (clinicaltrials.gov)
    P1/2, N=450, Active, not recruiting, Merck Sharp & Dohme LLC | Phase classification: P2 --> P1/2
    Phase classification • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • patritumab deruxtecan (U3-1402) • ifinatamab deruxtecan (DS-7300) • vibostolimab (MK-7684) • MK-0482 • MK-4830