For US Residents only, 18 years or older

Do You Have Recurrent
Low-Grade Serous Ovarian Cancer (LGSOC)?

Learn more about the RAMP 301 (Raf And Mek Program) Phase 3 clinical trial sponsored by Verastem Oncology.

Trial Information

Study Overview:

This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator’s Choice of Treatment options (ICT) in patients with recurrent (previously treated) LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both called kinase inhibitors which is a type of drug that may block cancer cell growth.

The purpose of the study is to assess how avutometinib plus defactinib compares to the standard treatments for LGSOC. The study will measure effectiveness, including overall response rate (how well the combination reduces tumor size) and safety.  The study will also include quality of life assessments by the patient. Gynecological cancer specialists are conducting the study.

Patients who are eligible and agree to participate in this study will be randomly assigned to receive either the investigational combination of avutometinib plus defactinib or one of five treatment options (selected by their doctor) considered standard treatments for recurrent LGSOC. Patients will have scheduled study visits to monitor their safety and how their disease is responding to the assigned treatment. Patients who are assigned to one of the standard treatments and experience progressive disease may be eligible to receive the investigational combination avutometinib plus defactinib.

Avutometinib and defactinib are investigational drugs and not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority, either as a single agent or in combination.

Protocol title:

GOG-3097/ENGOT-ov81/NCRI/RAMP 301: 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)

Protocol numbers:

VS-6766-301 (Verastem, Inc.) Clinical Trial NCT06072781GOG-3097 (The GOG Foundation) ENGOT-ov81/NCRI (European Network for Gynaecological Oncological Trial groups)

Study Drugs or Compounds:

avutometinib and defactinib

Study Phase:

Phase 3

Total Enrollment:

Approximately 270 patients

Study Short Title:

A Phase 3 study of avutometinib and defactinib versus investigator’s choice of treatment in recurrent low-grade serous ovarian cancer


Verastem Oncology

African female patient with glasses

Understanding Clinical Trials

Clinical trials are studies run by health care professionals (HCPs) that can determine if a new medicine or treatment works and is safe for people to use. All new medicines and medicine combinations must go through clinical trials before they can be approved by the Food and Drug Administration (FDA).

Clinical trials study different aspects of medicines and how they interact with the body. HCPs will determine the safest dose, which side effects are caused by the treatment, and if the treatment is effective.

Clinical trials follow certain steps in order, called phases, to protect the safety of trial participants and ensure the trial results for each phase are accurate. Phase 1 trials evaluate safety and Phase 2 clinical trials evaluate initial efficacy and safety of a treatment. If results from the Phase 2 clinical trials show the treatment both works and is safe, doctors are then able to pursue a Phase 3 clinical trial.

 Learn More About How Cancer Clinical Trials Work

Read this factsheet from the American Society of Clinical Oncology.

Redirection Notice

The information on this website is intended for US healthcare professionals only. Confirm you are a US healthcare professional to proceed.

Redirection Notice

The information on this website is intended for US healthcare professionals only. Confirm you are a US healthcare professional to proceed.