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Therapy Name MK-7684A
Synonyms
Therapy Description

MK-7684A is a co-formulation of the immune checkpoint inhibitor Keytruda (pembrolizumab) and MK-7684 (Vibostolimab), an antibody directed against T-cell immunoreceptor with Ig and ITIM domains (TIGIT), which may lead to the activation of immune response against tumor cells (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
MK-7684A MK-7684/MK-3475|Vibostolimab/Pembrolizumab Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 TIGIT Antibody 19 MK-7684A is a co-formulation of the immune checkpoint inhibitor Keytruda (pembrolizumab) and MK-7684 (Vibostolimab), an antibody directed against T-cell immunoreceptor with Ig and ITIM domains (TIGIT), which may lead to the activation of immune response against tumor cells (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CD274 positive head and neck squamous cell carcinoma predicted - sensitive MK-7684A Phase II Actionable In a Phase II trial (KEYVIBE-005), MK-7684A treatment resulted in an objective response rate (ORR) of 29% (12/42), a median duration of response of 12.7 months, a median progression survival of 4.1 months, and a median overall survival of 15.5 months in patients with CD274 (PD-L1)-positive (CPS>/=1) head and neck squamous cell carcinoma, with an ORR of 21% (5/24) in patients with CPS=1-19 and an ORR of 41% with CPS>/=20 (Ann Oncol (2024) 35 (Suppl_2): S617-S618; NCT05007106). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04738487 Phase III Pembrolizumab MK-7684A Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003) Active, not recruiting USA | TUR | ROU | HUN | CAN | BRA 17
NCT05665595 Phase III Pembrolizumab MK-7684A A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) Active, not recruiting USA | TUR | SWE | POL | NZL | ITA | ISR | IRL | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG 7
NCT04725188 Phase II Docetaxel Docetaxel + MK-7684A MK-7684A Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002) Completed USA | POL | ITA | ISR | FRA | FIN | ESP | DNK | DEU | CHE | BRA | BEL | AUT | AUS | ARG 5
NCT06395090 Phase Ib/II MK-7684A MK-4280 + Pembrolizumab Pembrolizumab + Vibostolimab MK-4280A A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01) Withdrawn USA 2
NCT05007106 Phase II MK-7684A + Paclitaxel Cisplatin + Fluorouracil + MK-7684A Pembrolizumab Lenvatinib + MK-7684A MK-7684A MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Active, not recruiting USA | TUR | POL | NLD | ITA | ISR | FRA | ESP | DEU | CAN 5
NCT04895722 Phase II MK-4280A MK-7684A MK-1308A MK-4830 + Pembrolizumab Pembrolizumab Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) Active, not recruiting USA | TUR | ROU | POL | NLD | LTU | ITA | HUN | GRC | GBR | FRA | EST | ESP | DNK | DEU | CAN | BEL 5
NCT05005442 Phase II MK-7684A A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004) Completed USA | TUR | POL | ITA | ISR | HUN | FRA | ESP | DNK | DEU | CAN | BRA 4


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