RecruitingPhase 3NCT06072781

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

Sponsor

Verastem, Inc.

Enrollment

270 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Low Grade Serous Ovarian Cancer

Summary

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a two-drug combination — avutometinib and defactinib — for people with recurrent low-grade serous ovarian cancer (LGSOC), a slow-growing but hard-to-treat form of ovarian cancer. Both drugs target specific cancer cell signaling pathways, and researchers want to see whether they outperform standard options. **You may be eligible if...** - You have been diagnosed with low-grade serous ovarian, fallopian tube, or peritoneal cancer - Your cancer has come back or progressed after at least one prior systemic treatment - You have measurable disease visible on imaging - You have a documented test result for the KRAS gene mutation status - Your overall health is good (ECOG ≤ 1) and organ function is adequate **You may NOT be eligible if...** - You have received prior treatment with MEK inhibitors or FAK inhibitors (the type of drugs being studied) - Your cancer is a different subtype (e.g., high-grade serous ovarian cancer) - You have serious heart, liver, or eye conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGavutometinib

Avutometinib: administered orally

DRUGDefactinib

Defactinib: administered orally

DRUGPegylated liposomal doxorubicin

administered intravenously

DRUGPaclitaxel

administered intravenously

DRUGLetrozole

administered orally

DRUGAnastrozole

administered orally

Locations(106)

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

Naples, Italy

Istituto Oncologico Veneto (IOV)

Padova, 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

Aichi Cancer Center Hospital

Aichi, Nagoya, 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

View Full Details on ClinicalTrials.gov

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NCT06072781