Cancers gynécologiques

VS-6766-301 (RAMP 301)

A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus;InvestigatorÀs Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC).

Open at Paris since : 09/10/2024
Target : Adult
Phase : Phase III

Trial description

1/ To compare the progression-free survival (PFS) of the;combination of avutometinib plus defactinib vs;InvestigatorÀs Choice of Treatment (ICT) in patients;with recurrent LGSOC;2/ To compare the combination of avutometinib plus;defactinib vs ICT in patients with recurrent LGSOC;with regard to additional efficacy parameters;3/ To characterize the safety and tolerability of;combination avutometinib plus defactinib vs ICT in;patients with recurrent LGSOC;4/ To determine the exposure of avutometinib and;defactinib in patients with recurrent LGSOC treated;with combination of avutometinib plus defactinib;5/ To assess the health-related quality of life and disease;related symptoms in patients with recurrent LGSOC;treated with combination avutometinib plus defactinib;vs ICT.

Url of the trial

Main investigator

MANUEL RODRIGUES

Médecin

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