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Can a Two-Drug combo keep fighting a rare ovarian cancer?

NCT ID NCT07747506

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study offers continued access to an experimental combination of two oral drugs—avutometinib and defactinib—for people with recurrent low-grade serous ovarian cancer (LGSOC) who have already been benefiting from this treatment in a prior study. The goal is to allow uninterrupted treatment while collecting additional information on safety and how long people can stay on the therapy. Participation is limited to those who are directly transitioning from the earlier RAMP-201 study, ensuring continuity of care for this specific group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
avutometinib in combination with defactinib (oral drugs)
What this could lead to
If successful, this could provide a way for people with recurrent low-grade serous ovarian cancer to keep receiving a potentially beneficial treatment without interruption, while gathering more safety data.
What could go wrong
This is a small extension study, not a new test of effectiveness. It only includes a very limited number of participants who already responded to the drugs, so results may not apply to a broader population. Side effects from extended use are still being monitored.
Why investors are watching

Verastem is running a small open-label extension study that lets French patients with recurrent low-grade serous ovarian cancer continue taking avutometinib plus defactinib after finishing the main RAMP-201 trial. For a micro-cap company, this readout matters because it shows whether the drug combination remains tolerable and keeps working over longer treatment, which supports the drug's broader case. The result is consequential because Verastem's value depends heavily on this single drug pair.

If it works: A positive result could show the combination stays safe and effective with extended use, strengthening the case for regulatory approval and broader adoption. That could help Verastem secure partnerships or funding for later-stage work.

If it fails: A failure or delay could raise doubts about the drug's long-term safety or benefit, hurting Verastem's prospects. Trials often fail or stall, and this small study offers limited evidence on its own.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 2 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Currently active on VS-6766-201(RAMP-201) study while receiving avutometinib in combination with defactinib, have not required prior permanent discontinuation of avutometinib plus defactinib. Any active dose hold from the RAMP-201 study should be ≤ 28 days at the time of Screening for the OLE study. 2. Investigator assessment that the participant is deriving clinical benefit from study treatment (e.g., complete response, partial response, or stable disease), as determined by the investigator. 3. Female participants of childbearing potential must agree to use a highly effective method of contraception throughout OLE study participation and for at least 30 days after the last dose of study treatment. Note: Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening/Eligibility prior to the first OLE dose. 4. Ability and willingness to provide written informed consent for participation in the study and for continued data collection. Exclusion Criteria: 1. Radiographic or clinical disease progression or discontinuation of treatment for any reason during the VS-6766-201 (RAMP-201) study or at the time of screening in this study. 2. Participants on an active dose hold in the VS-6766-201 (RAMP-201) study may transition to this study only after the underlying issue has been clinically resolved and the investigator, in consultation with the Sponsor, confirms that continued treatment is appropriate. 3. Receipt of new systemic anti-cancer therapy since participation in the RAMP-201 study. 4. Participation in another interventional clinical study or receipt of other investigational therapy since participation in VS-6766-201 (RAMP-201) study. 5. Any active or uncontrolled medical condition that, in the investigator's judgment, would pose unacceptable risk or interfere with continued treatment, including but not limited to severe cardiac, pulmonary, neurologic, dermatologic, gastrointestinal, hepatic, or active infectious disease. 6. Any active or history of clinically significant ocular disorder that may increase the risk of MEK-inhibitor-related ocular toxicity (e.g., retinal vein occlusion, serous retinopathy, retinal detachment, or clinically significant macular pathology). 7. Concomitant use of medications known to have clinically significant interactions with avutometinib or defactinib that cannot be safely discontinued or substituted prior to study dosing (e.g., strong CYP3A4 inducers or inhibitors, warfarin). 8. Positive pregnancy test at Screening, breastfeeding, or unwillingness to use adequate contraception during the study. 9. Any condition or circumstance that, in the investigator's opinion, may compromise participant safety, compliance or continued benefit from study treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Centre Leon Berard

    Lyon, 69008, France

  • Institut Curie

    Paris, 75248, France

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