36
Participants
Start Date
June 4, 2019
Primary Completion Date
January 15, 2025
Study Completion Date
January 15, 2026
Pembrolizumab
Following standard of care neoadjuvant chemotherapy, subjects will receive two doses of pembrolizumab (200mg) IV 3 weeks apart prior to surgery. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 8 doses of pembrolizumab (200mg) IV 3 weeks apart.
Defactinib
Following 2 cycles of standard of care neoadjuvant chemotherapy, subjects will receive 400 mg defactinib twice a day up until 2 days preceding their surgery (approximately 6 weeks) during the immunotherapy cycles with pembrolizumab. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 400mg defactinib twice a day for 24 weeks.
Sidney Kimmel Comprehensive Cancer Center, Baltimore
The University of Texas Health Science Center San Antonio, San Antonio
Samuel Oschin Cancer Center at Cedars-Sinai, Los Angeles
Merck Sharp & Dohme LLC
INDUSTRY
Verastem, Inc.
INDUSTRY
Lei Zheng
OTHER