RAMP301
Research type
Research Study
Full title
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)
IRAS ID
1009195
Contact name
Elizabeth Noble
Contact email
Sponsor organisation
Verastem Oncology, Inc
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
The study is comparing the combination of two investigational new drugs called avutometinib (also known as VS-6766) and defactinib (also known as VS-6063) against standard of care treatments that are commonly used for previously treated low grade serous ovarian cancer (LGSOC) (also referred to as Investigator’s Choice of Treatment). 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 being assigned to each group. The first group will receive the study drugs: avutometinib (VS-6766) 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. Patients assigned to Group 2 and cancer worsens during treatment, patients can switch (crossover) to Group 1 treatment if the study doctor confirms that it is safe for patients to crossover. 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. For cancer cells that are dependent on estrogen, this can even cause the cells to die. How long participants remain on treatment depends on how well the cancer responds and how well participants are able to tolerate any side effects they may experience. If participants come off study treatment and the study scans do not show growth in the cancer, they will continue to have scans every 8-12 weeks until they start a new cancer medicine or they have a scan showing the cancer has grown. Participants will also be contacted by the study team approximately every 3 months for up to 5 years after the last patient has joined the study. They will be asked how they are doing in terms of your overall health and if they have started any new medicine for their cancer.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/1012
Date of REC Opinion
26 Jan 2024
REC opinion
Further Information Favourable Opinion