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) (RAMP301)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508204-38-00

Acronym

VS-6766-301

Enrollment

183

Registered

2024-05-22

Start date

2024-07-02

Completion date

Unknown

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Brief summary

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, per blinded independent central review (BICR)

Detailed description

Unless otherwise specified, all tumor response-based endpoints will be analyzed using both BICR and Investigator assessments. • Overall Survival (OS) • PFS according to RECIST v1.1, per Investigator Assessment • Objective response rate (ORR) • Duration of response (DoR) • Disease control rate (DCR), defined as having achieved a best response of complete response (CR) or partial response (PR), or stable disease (SD) documented at ≥ Week 24

Interventions

DRUGTopotecan HEXAL 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPaclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGAnastrozol STADA® 1 mg Filmtabletten

DRUGCaelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion

DRUGVS-6766

DRUGLETRO-cell® 2

DRUG5 mg Filmtabletten

DRUGVS-6063

DRUGLetrozol - 1 A Pharma® 2

DRUGZOLSKETIL pegylated liposomal 2 mg/mL concentrate for dispersion for infusion

DRUGAnastrozol - 1 A Pharma 1 mg Filmtabletten

DRUGLetrozol STADA® 2

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, per blinded independent central review (BICR)	—

Secondary

Measure	Time frame
Unless otherwise specified, all tumor response-based endpoints will be analyzed using both BICR and Investigator assessments. • Overall Survival (OS) • PFS according to RECIST v1.1, per Investigator Assessment • Objective response rate (ORR) • Duration of response (DoR) • Disease control rate (DCR), defined as having achieved a best response of complete response (CR) or partial response (PR), or stable disease (SD) documented at ≥ Week 24	—

Measure

Time frame

—

Countries

Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026