OncoMatch/Clinical Trials/NCT05983159
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations
Is NCT05983159 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Alpelisib and Mirdametinib for slow-flow vascular malformation.
Treatment: Alpelisib · Mirdametinib — Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PIK3CA mutation
A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: PIK3R1 mutation
A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: AKT1 mutation
A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: TEK mutation
A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: PTEN mutation
A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: MAP2K1 mutation
A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: KRAS G12C
A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: KRAS G12D
A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: NRAS mutation
A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study
Required: BRAF mutation
A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study
Prior therapy
Must have received: standard therapy (sirolimus)
Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate - Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment
Cannot have received: alpha-specific PI3K inhibitor
Prior use of an alpha-specific PI3K inhibitor
Cannot have received: MEK inhibitor
Prior use of a MEK inhibitor
Lab requirements
Blood counts
Haemoglobin ≥ 9.0 g/dL (except where bleeding leading to low haemoglobin is an indication for treatment); ANC ≥ 1.5 x 10^9/L; Platelets ≥ 90 x 10^9/L
Kidney function
Serum creatinine < 1.5 x ULN
Liver function
ALT and AST ≤ 3 x ULN (Module 1); ALT and AST ≤ 2 x ULN (Module 2); Total bilirubin < 2x ULN (Module 1), < 1.5x ULN (Module 2), with exceptions as noted
Adequate haematologic and end-organ function (see criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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