A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
NCT ID: NCT04625270
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
225 participants
INTERVENTIONAL
2020-12-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
avutometinib (VS-6766)
avutometinib (VS-6766) monotherapy
avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Part B
To determine the efficacy of the optimal regimen identified from Part A
avutometinib (VS-6766)
avutometinib (VS-6766) monotherapy
avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Part C:
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Part D
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Interventions
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avutometinib (VS-6766)
avutometinib (VS-6766) monotherapy
avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
* Measurable disease according to RECIST 1.1
* An Eastern Cooperative Group (ECOG) performance status ≤ 1.
* Adequate organ function
* Adequate recovery from toxicities related to prior treatments
* Agreement to use highly effective method of contraceptive, if necessary
Exclusion Criteria
* Co-existing high-grade ovarian cancer or another histology
* History of prior malignancy with recurrence \<3 years from the time of enrollment
* Major surgery within 4 weeks
* Symptomatic brain metastases requiring steroids or other interventions
* Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
* For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
* Active skin disorder that has required systemic therapy within the past year
* History of rhabdomyolysis
* Concurrent ocular disorders
* Concurrent heart disease or severe obstructive pulmonary disease
* Subjects with the inability to swallow oral medications
18 Years
FEMALE
No
Sponsors
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
GOG Foundation
NETWORK
Verastem, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susana Banerjee, MBBS,MA,PhD
Role: PRINCIPAL_INVESTIGATOR
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Rachel Grisham, MD
Role: PRINCIPAL_INVESTIGATOR
GOG Foundation
MD Verastem
Role: STUDY_DIRECTOR
Verastem, Inc.
Locations
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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
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Women's Health Institute
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology Austin Central
Austin, Texas, United States
Texas Oncology- Dallas Presbyterian Hospital
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology
Longview, Texas, United States
Texas Oncology
McAllen, Texas, United States
Texas Oncology
San Antonio, Texas, United States
Texas Oncology
The Woodlands, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
UZ Gent Medische Oncologie
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liege
Liège, , Belgium
Centre de recherche di Centre Hospitalier de i'Universite de Montreal
Montreal, , Canada
Princess Margaret Cancer Centre
Toronto, , Canada
Hopital Jean Minjoz
Besançon, , France
Centre Leon Berard
Lyon, , France
ICM - Val d'Aurelle
Montpellier, , France
Institut Curie
Paris, , France
Insituto Europeo di Oncologia I.R.C.C.S
Milan, , Italy
U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.
Padua, , Italy
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Western General Hospital
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
UCLH Cancer Clinical Trials Unit
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Banerjee SN, Van Nieuwenhuysen E, Aghajanian C, D'Hondt V, Monk BJ, Clamp A, Prendergast E, Oaknin A, Ring K, Colombo N, Holloway RW, Rodrigues M, Chon HS, Gourley C, Santin AD, Thaker PH, Gennigens C, Newman G, Salinas E, Youssoufian H, Moore KN, Lustgarten S, O'Malley DM, Van Gorp T, Grisham RN. Efficacy and Safety of Avutometinib +/- Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. J Clin Oncol. 2025 Sep;43(25):2782-2792. doi: 10.1200/JCO-25-00112. Epub 2025 Jul 11.
McNamara B, Demirkiran C, Hartwich TMP, Bellone S, Manavella D, Mutlu L, Greenman M, Zipponi M, Yang-Hartwich Y, Yang K, Ratner E, Schwartz PE, Coma S, Pachter JA, Santin AD. Preclinical efficacy of RAF/MEK clamp avutometinib in combination with FAK inhibition in low grade serous ovarian cancer. Gynecol Oncol. 2024 Apr;183:133-140. doi: 10.1016/j.ygyno.2024.01.028. Epub 2024 Mar 15.
Other Identifiers
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GOG-3052
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-ov60
Identifier Type: OTHER
Identifier Source: secondary_id
VS-6766-201
Identifier Type: -
Identifier Source: org_study_id
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