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DRUG:

vibostolimab/pembrolizumab (MK-7684A)

i
Other names: MK-7684A, MK-7684/MK-3475
Associations
Company:
Merck (MSD)
Drug class:
PD1 inhibitor, TIGIT inhibitor
Related drugs:
Associations
2d
Enrollment closed
|
Keytruda (pembrolizumab) • vibostolimab/pembrolizumab (MK-7684A)
7d
New P1/2 trial • Combination therapy • Tumor mutational burden
|
favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
20d
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001) (clinicaltrials.gov)
P1, N=492, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2024 --> Aug 2024 | Trial primary completion date: Oct 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • etoposide IV • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
20d
Enrollment closed • Combination therapy
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
3ms
Enrollment closed • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Padcev (enfortumab vedotin-ejfv) • favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
6ms
Phase classification • Combination therapy
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
11ms
Enrollment closed • Combination therapy
|
cisplatin • Tecentriq (atezolizumab) • carboplatin • etoposide IV • vibostolimab/pembrolizumab (MK-7684A)
11ms
Enrollment open • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Padcev (enfortumab vedotin-ejfv) • favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
12ms
Enrollment closed • Combination therapy • Metastases
|
cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • vibostolimab/pembrolizumab (MK-7684A)
1year
New P1/2 trial • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Padcev (enfortumab vedotin-ejfv) • favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
1year
Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
docetaxel • vibostolimab/pembrolizumab (MK-7684A)
1year
New P1/2 trial • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Padcev (enfortumab vedotin-ejfv) • favezelimab/pembrolizumab (MK-4280A) • vibostolimab/pembrolizumab (MK-7684A)
over1year
Trial primary completion date • Mismatch repair
|
EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
|
MSI-H/dMMR • RAS wild-type
|
Keytruda (pembrolizumab) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
almost2years
A Multicohort, Open-Label, Phase 2 Study of a Coformulation of Vibostolimab and Pembrolizumab in Patients with Relapsed or Refractory (R/R) Hematologic Malignancies: KEYVIBE-004 (PPLC 2022)
The results of this study will elucidate the role and PK characteristics of the coformulation of vibostolimab and pembrolizumab in R/R hematologic malignancies.
Clinical • P2 data
|
TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
vibostolimab/pembrolizumab (MK-7684A)
almost2years
Enrollment closed
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
docetaxel • vibostolimab/pembrolizumab (MK-7684A)
almost2years
Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • etoposide IV • vibostolimab/pembrolizumab (MK-7684A)
2years
Trial completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • vibostolimab/pembrolizumab (MK-7684A)
2years
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001) (clinicaltrials.gov)
P1, N=492, Active, not recruiting, Merck Sharp & Dohme Corp. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • etoposide IV • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
2years
Enrollment change • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • vibostolimab/pembrolizumab (MK-7684A)
2years
New P3 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • etoposide IV • vibostolimab/pembrolizumab (MK-7684A)
2years
KeyVibe-003: Randomized, double-blind, phase 3 study of first-line pembrolizumab with and without vibostolimab (anti-TIGIT) in patients with PD-L1-positive metastatic NSCLC (AACR 2022)
The current phase 3 study (KeyVibe-003; ClinicalTrials.gov, NCT04738487) is comparing first-line treatment with MK-7684A, a co-formulation of vibostolimab plus pembrolizumab, versus pembrolizumab monotherapy in patients with PD-L1-positive metastatic NSCLC. This randomized, multicenter, double-blind study is enrolling adults with pathologically confirmed, previously untreated, metastatic NSCLC with PD-L1 TPS ≥1% (centrally confirmed). N/A
Clinical • P3 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
PD-L1 expression • EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
2years
New P3 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • EGFR L858R • ALK rearrangement
|
vibostolimab/pembrolizumab (MK-7684A)
over2years
Enrollment change • Trial completion date • Mismatch repair
|
EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
|
MSI-H/dMMR • RAS wild-type
|
Keytruda (pembrolizumab) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
over2years
Safety and Efficacy of Vibostolimab and Pembrolizumab in Patients with Relapsed or Refractory Hematologic Malignancies: A Multicohort, Open-Label, Phase 2 Study (ASH 2021)
Background: The T-cell immunoglobulin and ITIM domain (TIGIT) is highly coexpressed with programmed cell death 1 (PD-1) on both CD4 and CD8 T cells in cancers. In the part 2 dose-expansion phase, the plan is to enroll approximately 120 patients from cohorts B-E to receive up to 35 cycles of MK-7684A Q3W; 30 additional patients may be enrolled in a cohort expansion (cohort G) to receive vibostolimab monotherapy Q3W for up to 35 cycles. Cohort G will include patients with cHL or PMBCL with PD after ≥2 or ≥3 prior therapies, FL after ≥2 prior therapies, DLBCL after ≥2 prior therapies, and/or MM after ≥3 prior therapies.
Clinical • P2 data
|
CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
over2years
Clinical • Enrollment open
|
BTK (Bruton Tyrosine Kinase)
|
vibostolimab/pembrolizumab (MK-7684A)
over2years
Phase 3 study of first-line pembrolizumab with and without vibostolimab (anti-TIGIT) in patients with PD-L1–positive metastatic NSCLC (SITC 2021)
The current phase 3 study (NCT04738487) is comparing first-line treatment with MK-7684A, a co-formulation of vibostolimab plus pembrolizumab, versus pembrolizumab monotherapy in patients with PD-L1–positive metastatic NSCLC. Enrollment began in April of 2021, and is ongoing at 42 sites in 11 countries. Trial Registration ClinicalTrials.gov, NCT04738487
Clinical • P3 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
PD-L1 expression • EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
over2years
[VIRTUAL] Phase 3 Study of First - Line Pembrolizumab ± Vibostolimab (anti - TIGIT) in Patients With PD - L1‒Positive Metastatic NSCLC (IASLC-WCLC 2021)
The current phase 3 study (NCT04738487) is comparing the efficacy and safety of first-line treatment with MK-7684A, a co-formulation of vibostolimab plus pembrolizumab, versus pembrolizumab monotherapy in patients with PD-L1-positive metastatic NSCLC. Approximately 598 patients will be randomized. Enrollment began in April of 2021.
Clinical • P3 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
PD-L1 expression • EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
almost3years
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
|
PD-L1 expression • MSI-H/dMMR • PD-L1 negative
|
Lenvima (lenvatinib) • vibostolimab/pembrolizumab (MK-7684A)
3years
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
docetaxel • vibostolimab/pembrolizumab (MK-7684A)
3years
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) (clinicaltrials.gov)
P1, N=492, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • etoposide IV • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
3years
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • vibostolimab/pembrolizumab (MK-7684A)
3years
New P2 trial
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
docetaxel • vibostolimab/pembrolizumab (MK-7684A)
3years
Clinical • New P3 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression
|
vibostolimab/pembrolizumab (MK-7684A)
over3years
Clinical • New P3 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • vibostolimab/pembrolizumab (MK-7684A)
over3years
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) (clinicaltrials.gov)
P1, N=492, Recruiting, Merck Sharp & Dohme Corp. | Trial primary completion date: Sep 2023 --> Jan 2024 | Trial completion date: Sep 2023 --> Jan 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • etoposide IV • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)
over3years
Clinical • New P2 trial
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
docetaxel • vibostolimab/pembrolizumab (MK-7684A)
over3years
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) (clinicaltrials.gov)
P1, N=492, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Jun 2022 --> Sep 2023 | Trial primary completion date: Jun 2022 --> Sep 2023
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • etoposide IV • vibostolimab (MK-7684) • vibostolimab/pembrolizumab (MK-7684A)