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A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

ConditionLow Grade Serous Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVerastem, Inc.

About this trial

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven LGSOC (ovarian, fallopian, peritoneal)

Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.

Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.

Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.

Disqualifiers

Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.

Co-existing high-grade serous ovarian cancer or mixed histology.

Prior treatment with avutometinib, defactinib, or other FAK inhibitors.

History of prior malignancy with recurrence <3 years from the time of enrollment.

Trial design

Design model

Crossover

Treatments tested in this trial

  • avutometinib

    Drug

    Avutometinib: administered orally

  • Defactinib

    Drug

    Defactinib: administered orally

  • Pegylated liposomal doxorubicin

    Drug

    administered intravenously

  • Paclitaxel

    Drug

    administered intravenously

  • Letrozole

    Drug

    administered orally

  • Anastrozole

    Drug

    administered orally

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: avutometinib + defactinibExperimental treatment 2 interventions
Group B: Investigator Choice of Treatment (ICT)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) per blinded independent central review (BICR)

Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)

Time frame
Up to 24 months

Secondary outcomes

1

Overall Survival (OS)

From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause

Time frame
Up to 5 years
2

Progression Free Survival (PFS) per investigator assessment

Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)

Time frame
24 months
3

Objective response rate (ORR)

From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause

Time frame
12 months
4

Duration of Response (DOR)

From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Verastem, Inc.

Lead sponsor

GOG Foundation

Collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Australia New Zealand Gynaecological Oncology Group

Collaborator

Korean Gynecologic Oncology Group

Collaborator

Source ClinicalTrials.gov
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