A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
NCT ID: NCT06072781
Last Updated: 2025-11-14
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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RECRUITING
PHASE3
270 participants
INTERVENTIONAL
2024-03-18
2031-02-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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avutometinib + defactinib
Avutometinib 3.2 mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle.
avutometinib
Avutometinib: administered orally
Defactinib
Defactinib: administered orally
Investigator Choice of Treatment (ICT)
Patients will receive one of the following therapies as determined by the Investigator:
* Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle.
* Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle.
* Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle.
* Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle.
Paclitaxel
administered intravenously
Letrozole
administered orally
Anastrozole
administered orally
Pegylated liposomal doxorubicin
administered intravenously
Interventions
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Paclitaxel
administered intravenously
Letrozole
administered orally
Anastrozole
administered orally
avutometinib
Avutometinib: administered orally
Defactinib
Defactinib: administered orally
Pegylated liposomal doxorubicin
administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)
2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
5. Measurable disease according to RECIST v1.1.
6. An Eastern Cooperative Group (ECOG) performance status ≤ 1.
7. Adequate organ function.
8. Adequate recovery from toxicities related to prior treatments.
9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
10. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
2. Co-existing high-grade serous ovarian cancer or mixed histology.
3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
4. History of prior malignancy with recurrence \<3 years from the time of enrollment.
5. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
6. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
8. History of medically significant rhabdomyolysis.
9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention
11. Concurrent ocular disorders.
12. Concurrent heart disease or severe obstructive pulmonary disease.
13. Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
14. Subjects with the inability to swallow oral medications.
15. History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
16. Pregnant or breastfeeding.
17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Australia New Zealand Gynaecological Oncology Group
OTHER
Korean Gynecologic Oncology Group
OTHER
Verastem, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rachel Grisham, MD
Role: PRINCIPAL_INVESTIGATOR
GOG Foundation
Susana Banerjee, MBBS, MA, PhD
Role: PRINCIPAL_INVESTIGATOR
European Network of Gynecological Oncological Trial Groups (ENGOT)
Locations
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HonorHealth
Phoenix, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
UCLA Health
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Mount Sinai
Miami Beach, Florida, United States
AdventHealth
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialists Research East
West Palm Beach, Florida, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Louisiana State University
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State
Hilliard, Ohio, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Asplundh Cancer Pavilion | Jefferson Health
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Texas Oncology Central
Austin, Texas, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States
Houston Methodist
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology
San Antonio, Texas, United States
Texas Oncology
The Woodlands, Texas, United States
Texas Oncology
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
UZA
Edegem, , Belgium
University Hospital Ghent
Ghent, , Belgium
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
British of Columbia
Vancouver, , Canada
Aalborg U.H
Aalborg, , Denmark
Centre Hospitalier de Besançon
Besançon, , France
Site Georges François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Curie
Paris, , France
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Kliniken Essen-Mitte
Essen, , Germany
UMC Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Mannheim GmbH
Mannheim, , Germany
Universitätsfrauenkinik Ulm
Ulm, , Germany
St. James's Hospital
Dublin, , Ireland
Centro di Riferimento Oncologico (CRO)
Aviano, , Italy
Spedali Civili
Brescia, , Italy
AO Cannizzaro
Catania, , Italy
San Raffaele Hospital
Milan, , Italy
Humanitas San Pio X
Milan, , Italy
European Institute of Oncology (IEO)
Milan, , Italy
Istituto Nazionale dei Tumori
Milan, , Italy
INT Napoli Hospital
Napoli, , Italy
Istituto Oncologico Veneto (IOV)
Padua, , Italy
IRCCS Gemelli
Roma, , Italy
Istituti Fisioterapici Ospitalieri
Rome, , Italy
S.C.D.U. Oncologia
Torino, , Italy
The Mie University Hospital
Tsu, Mie-ken, Japan
Tohoku University Hospital
Miyagi, , Japan
Osaka Medical Center
Osaka, , Japan
The Jikei University Hospital
Tokyo, , Japan
Netherlands Cancer Insitute
Amsterdam, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Białostockie Centrum Onkologii
Bialystok, , Poland
Gdański Uniwersytet Medyczny
Gdansk, , Poland
Siedleckie Centrum Onkologii
Siedlce, , Poland
Seoul National University Bundang Hospital
Seongnam, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Clínico Virgen de La Arrixaca
El Palmar, Murcia, Spain
H. de Donostia
Donostia / San Sebastian, San Sebastian, Spain
H. Vall d´ Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
H.U. Ramón y Cajal
Madrid, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Greater Glasgow and Clyde (GGC)
Glasgow, Scotland, United Kingdom
Cambridge University Hospital
Cambridge, , United Kingdom
University of Edinburgh Cancer Research Centre
Edinburgh, , United Kingdom
Hope Cancer Trials Centre
Leicester, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Sabrina Maham
Role: primary
Kathryn Allen
Role: primary
Jenny Lester
Role: primary
Johanna Han
Role: primary
Nathalie Halley
Role: primary
Lisa Baker
Role: primary
Christina Caruso
Role: primary
Antonio Ramirez Riderelli
Role: primary
Karla Hernandez-Cruz
Role: primary
Connor Hyde
Role: primary
Mary Jo Luser
Role: primary
Syed Ahsan
Role: primary
Michele Britto
Role: primary
Alex Yates
Role: primary
Faith Too
Role: primary
Role: backup
Elizabeth Linnik
Role: primary
Kayla McDonald
Role: primary
Linda Odibo
Role: primary
Kimberly Benczkowski
Role: primary
Rachel Grisham
Role: primary
Melani Terry
Role: primary
Jacqueline Ludwig
Role: primary
Jordyn Burks
Role: primary
Liz Barrett
Role: primary
Jeanne Scahffer
Role: primary
Jennifer Thompson
Role: primary
Ashley Douglas
Role: primary
Siobhan Guyach
Role: primary
Michelle Owens
Role: primary
Nori Sullivan
Role: primary
Konny Chan Fong
Role: primary
Mariana Gallardo, RN
Role: primary
Shannon Syring
Role: primary
Christina Genthon
Role: primary
Sandra Thornton
Role: backup
Shelly Maxfield
Role: primary
Stacy Howard
Role: primary
Zdravka (Ava) Daneva
Role: primary
Monica Cochrane
Role: primary
Kaye Kongrak
Role: primary
Amy Morrow
Role: primary
Vineet Kwatra, MD
Role: primary
Nicole Marsh
Role: primary
Jolanta Damas
Role: primary
Griet Wyers
Role: primary
Hannelore Denys, MD
Role: primary
Valerie Bowering
Role: primary
Nathalie Grenier
Role: primary
Phuong Nam Nathalie Nguyen
Role: primary
Fran Topp, RN
Role: primary
Mette Raaschou
Role: primary
Ophélie Sivignon
Role: primary
Kevin Le Berre
Role: primary
Clémence Goetz
Role: primary
Emilie Repetto, MD
Role: primary
Manuel Rodrigues, MD
Role: primary
Madeleine Modrow
Role: primary
Radoslav Chekerov, MD
Role: primary
Elena Ioana Braicu, MD
Role: backup
Christine Griebsch
Role: primary
Theresa Link
Role: backup
Anna Kasperek
Role: primary
Juliane Granzow
Role: primary
Manuela Reining
Role: primary
Wolfgang Janni
Role: primary
Lauren Murphy
Role: primary
Serena Corsetti
Role: primary
Eliana Bignotti
Role: primary
Francesca Salanitro
Role: primary
Alessandra Paggin
Role: backup
Silvia Pagani
Role: primary
Ilaria Sabatucci
Role: primary
Beatrice Rizzoli
Role: primary
Barbara Montesanto
Role: primary
Margherita Tambaro
Role: primary
Giulia Doria
Role: primary
Giulia Ponti
Role: primary
Agnese Provenziani
Role: primary
Giorgio Valabrega
Role: primary
Eiji Kondo
Role: primary
Shogo Shigeta
Role: primary
Satoe Fujiwara
Role: primary
Aikou Okamoto
Role: primary
Geesje Feingold - van Olst
Role: primary
Daphne van Dijk
Role: primary
Merina Mathews
Role: primary
Justyna Sławińska
Role: primary
Łukasz Jędrzejewski
Role: primary
Tomasz Milewski
Role: primary
Małgorzata Będkowska
Role: backup
Kidong Kim
Role: primary
Jung Yeon Lee
Role: primary
Sang Wun Kim
Role: backup
Geum Hee Na
Role: primary
Mina Jang
Role: primary
Jae-Hoon Kim
Role: backup
Jung Eun Park
Role: primary
Chel Hun Choi
Role: backup
Ana Puertes Boix
Role: primary
Cristina Maria Churruca Galaz
Role: primary
Olga Padros
Role: primary
Asuncion Aranda
Role: primary
Iluminada Hernandez Blazquez
Role: primary
Laura Gendra Maneiro
Role: primary
Paloma Campos Bañegil
Role: primary
Ros Glasspool, MD
Role: primary
Regulatory Team
Role: primary
Olga Demyanov
Role: primary
Joey Wood, MD
Role: primary
Christian Paul Medina
Role: primary
Shibani Nicum, MD
Role: backup
Kylie Fitch
Role: primary
Linzi Davies
Role: primary
Kylie Fitch
Role: primary
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.
Grisham R, Monk BJ, Van Nieuwenhuysen E, Moore KN, Fabbro M, O'Malley DM, Oaknin A, Thaker P, Oza AM, Colombo N, Gershenson D, Aghajanian CA, Choi CH, Lee YC, Mirza MR, Coleman RL, Cobb L, Harter P, Lustgarten S, Youssoufian H, Banerjee S. GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301: a phase 3, randomized trial evaluating avutometinib plus defactinib compared with investigator's choice of treatment in patients with recurrent low grade serous ovarian cancer. Int J Gynecol Cancer. 2025 Jan 6:ijgc-2024-005919. doi: 10.1136/ijgc-2024-005919. Online ahead of print.
Other Identifiers
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GOG-3097
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-ov81
Identifier Type: OTHER
Identifier Source: secondary_id
VS-6766-301
Identifier Type: -
Identifier Source: org_study_id