Trial intelligence / Profile preview

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

NCT05564377Phase 2

Key facts

Status
Recruiting
Start
Apr 2023
Primary completion
Jul 2030
Countries
2
Sponsor
National Cancer Institute
Conditions
solid tumor
01

Overview

Phase 2, randomised, open-label trial of alpelisib, binimetinib, fluorouracil, fulvestrant, ipatasertib and 10 more in solid tumor (20 arms), sponsored by National Cancer Institute. Primary endpoints: Accrual of patients to ComboMATCH treatment trials at 8 years, Assignment of patients to ComboMATCH treatment trials at 8 years and 1 more. Started Apr 2023; status: recruiting.

02

Design

20 arms
Study design
RandomizedOpen-label
  • EAY191-N4 Arm I

    selumetinib + olaparib

  • EAY191-N4 Arm II

    selumetinib

  • EAY191-N2 Cohort I Arm I

    fulvestrant + binimetinib

  • EAY191-N2 Cohort I Arm II

    fulvestrant

  • EAY191-N2 Cohort II

    fulvestrant + binimetinib

  • EAY191-E4

    nilotinib + paclitaxel

14 more in the full profile.

03

Who it enrols

Patients with locally advanced or advanced solid tumors who have progressed on at least one line of standard systemic therapy or have no standard treatment, with measurable disease and available sequencing results from an NCI credentialed Designated Laboratory.

04

Endpoints

Primary

  • Accrual of patients to ComboMATCH treatment trials

  • Assignment of patients to ComboMATCH treatment trials

  • Enrollment rates to ComboMATCH treatment trials

Secondary

  • Rate of positive outcomes within the treatment trial defined cohorts

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