Cross-institutional, prospective, open label, single group basket study of combined CRAF and MEK inhibition in advanced-stage malignancies harboring BRAF mutations with impaired kinase activity - SORATRAM

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512887-77-00

Acronym

1056 SORATRAM

Enrollment

Registered

2024-10-07

Start date

2020-10-21

Completion date

Unknown

Last updated

2025-12-18

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

Conditions

advanced-stage malignancies harboring BRAF mutations with impaired kinase activity

Brief summary

MTD of trametinib given in combination with sorafenib

Detailed description

Secondary endpoints: • Adverse (AEs), serious adverse events (SAEs) • Disease control rate (SD, PR or CR according to RECIST 1.1), best response during trial treatment) • Overall response rate (CR or PR according to RECIST 1.1) at the end of cycle 4 and cycle 7 • Overall survival from start of trial treatment • Translational parameter Exploratory endpoints: • Progression free survival ratio (PFSr)

Interventions

DRUGNexavar 200 mg film-coated tablets

DRUGMekinist 0.5 mg film-coated tablets

DRUGSORAFENIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MTD of trametinib given in combination with sorafenib	—

Secondary

Measure	Time frame
Secondary endpoints: • Adverse (AEs), serious adverse events (SAEs) • Disease control rate (SD, PR or CR according to RECIST 1.1), best response during trial treatment) • Overall response rate (CR or PR according to RECIST 1.1) at the end of cycle 4 and cycle 7 • Overall survival from start of trial treatment • Translational parameter Exploratory endpoints: • Progression free survival ratio (PFSr)	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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