RAMP-301 (ENGOT ov81)

About this trial

There are no approved treatments specifically for low grade serous ovarian cancer; current standard of care treatment options are limited in efficacy and tolerability. The combination of avutometinib with defactinib has demonstrated efficacy and a consistent safety profile in two clinical trials in recurrent low grade serous ovarian cancer, and a lower discontinuation rate due to adverse events compared with historical rates for standard of care.

Avutometinib and defactinib are both types of drugs called kinase inhibitors. Kinase inhibitors block cancer cell growth. The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms.

Patient Profile

* Histologically proven LGSOC (ovarian, fallopian, peritoneal)
* Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
* Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.

Where’s this trial being run?

St James’s Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	RAMP-301 (ENGOT ov81)
Number:	25-16
Full Title:	RAMP-301 (ENGOT ov81) / 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)

Principal Investigator:	Prof. Karen Cadoo
Type:	Industry Sponsored and Collaborative
Sponsor:	Verastem
Recruitment Started:	Global: March 2024 Ireland: May 2025

Global Recruitment Target:	270
Ireland Recruitment Target: