A Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Trial ID #	NCT02964013
Phase	I
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name	Pembrolizumab
Alternate Drug Names	Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475
Drugs in Trial	Pembrolizumab, Vibostolimab
Eligible Participant	Recurrent ovarian cancer
Patients Enrolled	61 patients, median 3 prior therapies
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, evaluated per RECIST
Biomarkers	PD-L1 by CPS
Efficacy	ORR: 8% (5PR) DCR (6 months): 11% DoR: 19 months PFS: 2 months Exploratory analysis, PD-L1 CPS ≥1: PD-L1 CPS≥1 (n=21): ORR: 24% (5PR); DCR (6 months): 24%; DoR: 19 months; PFS: 2 months
Clinically Significant Adverse Events	Serious AE: 6.6% Grade 3-4 AE: overall (13%)
Conclusion	Vibostolimab+pembrolizumab is well tolerated and demonstrates anti-tumor activity in anti-PD-1/PD-L1 naive ovarian cancer patients; particularly in patients with PD-L1 CPS ≥1
Reference	Perets R et al. Safety and efficacy of vibostolimab (vibo) plus pembrolizumab (pembro) and coformulation of vibo/pembro in ovarian cancer naive to PD-1/PD-L1 inhibitors. Cancer Res (2022) 82 (12_Supplement): CT180 https://aacrjournals.org/cancerres/article/82/12_Supplement/CT180/703646 Perets R et al. Poster https://www.clearityfoundation.org/wp-content/uploads/2022/04/AACR-2022-Vibostolimab-and-Pembro-CT180-poster.pdf