A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation (RAMP 201)

V

Verastem

Status and phase

Active, not recruiting
Phase 2

Conditions

Low Grade Ovarian Serous Adenocarcinoma
Ovarian Cancer

Treatments

Drug: avutometinib (VS-6766) and defactinib
Drug: avutometinib (VS-6766)

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT04625270
ENGOT-ov60 (Other Identifier)
GOG-3052 (Other Identifier)
VS-6766-201

Details and patient eligibility

About

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Full description

This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.

Enrollment

225 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically proven LGSOC (ovarian, peritoneal)
  • Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  • Measurable disease according to RECIST 1.1
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Agreement to use highly effective method of contraceptive, if necessary

Exclusion criteria

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  • Co-existing high-grade ovarian cancer or another histology
  • History of prior malignancy with recurrence <3 years from the time of enrollment
  • Major surgery within 4 weeks
  • Symptomatic brain metastases requiring steroids or other interventions
  • Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
  • For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
  • Active skin disorder that has required systemic therapy within the past year
  • History of rhabdomyolysis
  • Concurrent ocular disorders
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Subjects with the inability to swallow oral medications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

225 participants in 4 patient groups

Part A
Experimental group
Description:
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
Treatment:
Drug: avutometinib (VS-6766)
Drug: avutometinib (VS-6766) and defactinib
Part B
Experimental group
Description:
To determine the efficacy of the optimal regimen identified from Part A
Treatment:
Drug: avutometinib (VS-6766)
Drug: avutometinib (VS-6766) and defactinib
Part C:
Experimental group
Description:
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
Treatment:
Drug: avutometinib (VS-6766) and defactinib
Part D
Experimental group
Description:
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Treatment:
Drug: avutometinib (VS-6766) and defactinib

Trial contacts and locations

47

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Central trial contact

Verastem Call Center

Data sourced from clinicaltrials.gov

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