FAQs

This study will compare the combination of avutometinib and defactinib against the standard of care treatments that are commonly used for recurrent LGSOC. In order to do this, participants will be randomly assigned to one of two groups. This will be done by a computer and will be like the flip of a coin – there is a 50:50 chance of you being assigned to either group. You and your study doctor will be told which group you are in. The first group will receive the study drugs: avutometinib and defactinib. The second group will receive one of the standard of care treatment options for LGSOC. These standard treatment options include chemotherapy or hormonal therapy. Chemotherapy slows cancer growth by interrupting cell division and causing the affected cells to die. Some LGSOC tumors can be encouraged to grow by the estrogen in your body. Hormonal therapy slows cancer growth by blocking the effect of estrogen on the cancer cells that are dependent on it. 
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The schedule of treatments may be different depending on the treatment you are assigned to. There may also be different safety procedures required depending on the chosen treatment.

If you are randomized to the standard of care treatment group and your cancer worsens during treatment, you could switch (crossover) to the study drugs (avutometinib and defactinib) if your study doctor confirms that it is safe for you to crossover. You will need to undergo crossover screening procedures to confirm eligibility.  

First, you will be asked to sign a consent form if you agree to be included in this study. If you take part in this study, you will need to follow the study procedures and attend all the study visits. You should report any side effects to the study doctor.If you take part in this study, you will have several types of visits: a screening visit, treatment visits, and an end of treatment follow-up visit.  The schedule of treatments may be different depending on the treatment you are assigned to. There may also be different safety procedures required depending on the treatment you are assigned to.

You will see your study doctor about 1-2 times a month to see how you are feeling and any symptoms you may have, and to draw blood samples for routine laboratory blood tests.  A CT (computerized tomography) scan of your chest, abdomen and pelvis to measure the size of your tumor(s) will be done at the beginning of your treatment.  At the end of every two or three treatment cycles (about every 8-12 weeks) you will have a repeat of the CT/MRI scan to measure your cancer.

No.  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.

You will not be paid for participating in this study; however, you will be reimbursed for reasonable and necessary expenses in connection with the study (e.g., parking, travel costs). Your study site coordinator is the best contact for examples of the types of expenses that could be covered.

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. In contrast to currently available MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. 

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part of its (Raf And Mek Program). RAMP 301 is a Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and has completed enrollment in the dose optimization and expansion phases and is enrolling for low-dose evaluation.