This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
avutometinib (VS-6766) monotherapy
avutometinib (VS-6766) and defactinib combination
Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
Confirmed overall response rate per RECIST 1.1
Time frame: From start of treatment to confirmation of response; 24 weeks
Part B: To determine the efficacy of the optimal regimen identified from Part A
Confirmed overall response rate per RECIST 1.1
Time frame: From start of treatment to confirmation of response; 24 weeks
Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A
Confirmed overall response rate per RECIST 1.1
Time frame: From start of treatment to confirmation of response; 24 weeks
Part D:To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Confirmed ORR defined according to RECIST 1.1
Time frame: From start of treatment to confirmation of response; 24 weeks
Overall Response Rate as assessed by Investigator
Proportioned subjects achieving a CR or PR as assess by the investigator
Time frame: From start of treatment to confirmation of response; 24 weeks
Duration of Response (DOR)
From time of first response to PD as assessed by the BIRC
Time frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months
Disease Control Rate (DCR)
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Arizona Oncology Associates PC HAL
Scottsdale, Arizona, United States
Sansum Clinic
Santa Barbara, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Advent Health
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Maryland Oncology and Hematology, P.A.
Glenn Dale, Maryland, United States
Minnesota Oncology Hematology PA
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
...and 37 more locations
CR+PR+stable disease
Time frame: Greater than or equal to 8 weeks
Progression Free Survival (PFS)
From time of first dose of study intervention to PD or death for any cause
Time frame: Up to 5 years
Overall Survival (OS)
From time of first dose of study intervention to death
Time frame: Up to 5 years