A Study of Avutometinib (VS-6766) V. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer with and Without a KRAS Mutation (RAMP 201)

January 26, 2025 updated by: Verastem, Inc.

A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and in Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • UZ Gent Medische Oncologie
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liege
  • Canada
      • Montréal, Canada, H2X 0A9
        • Centre de recherche di Centre Hospitalier de i'Universite de Montreal
      • Toronto, Canada, M5G2M9
        • Princess Margaret Cancer Centre
  • France
      • Besançon, France, 2500
        • Hopital Jean Minjoz
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • ICM - Val d'Aurelle
      • Paris, France, 75248
        • Institut Curie
  • Italy
      • Milano, Italy, 20141
        • Insituto Europeo di Oncologia I.R.C.C.S
      • Padova, Italy, 35128
        • U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G120YN
        • Beatson West Of Scotland Cancer Centre
      • London, United Kingdom, NW1 2PG
        • UCLH Cancer Clinical Trials Unit
      • Manchester, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Trust
      • Sutton, United Kingdom
        • Royal Marsden Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Oncology Associates PC HAL
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • Florida
      • Orlando, Florida, United States, 32804
        • Advent Health
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Maryland
      • Glenn Dale, Maryland, United States, 20769
        • Maryland Oncology and Hematology, P.A.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology PA
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Women's Health Institute
      • Columbus, Ohio, United States, 43212
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Medical Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology Austin Central
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology- Dallas Presbyterian Hospital
      • Longview, Texas, United States, 75601
        • Texas Oncology
      • McAllen, Texas, United States, 78503
        • Texas Oncology
      • San Antonio, Texas, United States, 78240
        • Texas Oncology
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven LGSOC (ovarian, peritoneal)
  • 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:

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part B
To determine the efficacy of the optimal regimen identified from Part A
Drug: avutometinib (VS-6766)
avutometinib (VS-6766) monotherapy
Drug: avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Other Names:
  • avutometinib (VS-6766) and VS-6063
Experimental: 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)
Drug: avutometinib (VS-6766)
avutometinib (VS-6766) monotherapy
Drug: avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Other Names:
  • avutometinib (VS-6766) and VS-6063
Experimental: Part C:
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
Drug: avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Other Names:
  • avutometinib (VS-6766) and VS-6063
Experimental: Part D
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Drug: avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Other Names:
  • avutometinib (VS-6766) and VS-6063

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part B: To determine the efficacy of the optimal regimen identified from Part A
Time Frame: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
From start of treatment to confirmation of response; 24 weeks
Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
Time Frame: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
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
Time Frame: From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
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
Time Frame: From start of treatment to confirmation of response; 24 weeks
Confirmed ORR defined according to RECIST 1.1
From start of treatment to confirmation of response; 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate as assessed by Investigator
Time Frame: From start of treatment to confirmation of response; 24 weeks
Proportioned subjects achieving a CR or PR as assess by the investigator
From start of treatment to confirmation of response; 24 weeks
Duration of Response (DOR)
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
From time of first response to PD as assessed by the BIRC
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)
Time Frame: Greater than or equal to 8 weeks
CR+PR+stable disease
Greater than or equal to 8 weeks
Progression Free Survival (PFS)
Time Frame: Up to 5 years
From time of first dose of study intervention to PD or death for any cause
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 5 years
From time of first dose of study intervention to death
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Verastem, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susana Banerjee, MBBS,MA,PhD, European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Principal Investigator: Rachel Grisham, MD, GOG Foundation
  • Study Director: MD Verastem, Verastem, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VS-6766-201
  • GOG-3052 (Other Identifier: The GOG Foundation, Inc.)
  • ENGOT-ov60 (Other Identifier: ENGOT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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