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Combination treatment for recurrent low-grade serous ovarian cancer

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) (RAMP 301)

Phase 3 Interventional Verastem, Inc. · NCT06072781

This study is testing a new combination of two drugs for people with recurrent low-grade serous ovarian cancer to see if it helps them live longer without their cancer getting worse compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexFemale
SponsorVerastem, Inc. Industry-sponsored
Drugs / interventionsavutometinib, defactinib, radiation, doxorubicin
Locations106 sites (Phoenix, Arizona and 105 other locations)
Trial IDNCT06072781 on ClinicalTrials.gov

What this trial studies

This international, randomized, open-label Phase 3 study evaluates the safety and efficacy of the investigational drugs avutometinib and defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) who have progressed after platinum-based therapy. Participants will be assigned to receive either the combination of these two drugs or one of the standard treatments recommended by the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO). The primary focus is on comparing progression-free survival (PFS) between the two groups, along with assessing safety, overall survival, and quality of life. The study aims to provide insights into the effectiveness of this novel combination therapy in managing recurrent LGSOC.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed low-grade serous ovarian cancer who have experienced disease progression after at least one prior systemic therapy.

Not a fit: Patients with non-recurrent low-grade serous ovarian cancer or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with recurrent low-grade serous ovarian cancer.

How similar studies have performed: Other studies involving kinase inhibitors have shown promise in treating various cancers, suggesting potential success for this approach in LGSOC.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Patients may be eligible for inclusion in the study if they meet the following criteria:

1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)
2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
5. Measurable disease according to RECIST v1.1.
6. An Eastern Cooperative Group (ECOG) performance status ≤ 1.
7. Adequate organ function.
8. Adequate recovery from toxicities related to prior treatments.
9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
10. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
2. Co-existing high-grade serous ovarian cancer or mixed histology.
3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
4. History of prior malignancy with recurrence \<3 years from the time of enrollment.
5. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
6. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
8. History of medically significant rhabdomyolysis.
9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention
11. Concurrent ocular disorders.
12. Concurrent heart disease or severe obstructive pulmonary disease.
13. Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
14. Subjects with the inability to swallow oral medications.
15. History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
16. Pregnant or breastfeeding.
17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Where this trial is running

Phoenix, Arizona and 105 other locations

+56 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Low Grade Serous Ovarian CancerKRASKRAS wtKRAS mt
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.