Trial Title:
Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)
NCT ID:
NCT06400225
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
EC
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Radionuclide Imaging
Description:
Undergo nuclear study
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
NM
Other name:
Nuclear Medicine
Other name:
nuclear medicine scan
Other name:
radioimaging
Other name:
Radionuclide Scanning
Other name:
Scan
Other name:
Scintigraphy
Intervention type:
Drug
Intervention name:
Ulixertinib
Description:
Given PO
Arm group label:
Treatment (BVD-523FB [ulixertinib])
Other name:
BVD-523
Other name:
VRT752271
Summary:
This phase II MATCH treatment trial tests how well BVD-523FB (ulixertinib) works in
treating patients with cancer that has certain genetic changes. BVD-523FB (ulixertinib)
is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It
is in a class of medications called kinase inhibitors. It works by blocking the action of
proteins that signal cancer cells to multiply. This helps slow or stop the spread of
cancer cells.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study
agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of
treatment with targeted study agent in patients with advanced refractory
cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential
predictive biomarkers beyond the genomic alteration by which treatment is assigned or
resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and
imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes
from pre- through post-therapy imaging can predict objective response and progression
free survival and to evaluate the association between pre-treatment radiomic phenotypes
and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive BVD-523FB (ulixertinib) orally (PO) twice daily (BID) on days 1-28 of
each cycle. Cycles repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or
magnetic resonance imaging (MRI) and blood sample collection throughout the trial.
Patients also undergo echocardiography (ECHO) or nuclear study (multigated acquisition
[MUGA] or similar scan) during screening and on study. Patients may also undergo biopsies
on study.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
- Patients must fulfill all eligibility criteria of MATCH Master Protocol at the time
of registration to treatment step (Step 1, 3, 5, 7)
- Patients must have a BRAF non-V600 mutation or BRAF fusion, or another BRAF
aberration, as determined via the MATCH Master Protocol
- Patients with BRAF V600E/K/R/D mutations are excluded
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
assignment and must have no clinically important abnormalities in rhythm, conduction
or morphology of resting ECG (e.g. complete left bundle branch block, third degree
heart block)
- Patients must not have known immediate or delayed hypersensitivity reaction or
idiosyncrasy to drugs chemically related to BVD-523FB (ulixertinib), dimethyl
sulfoxide (DMSO), or excipients
- Patients must not have a left ventricular ejection fraction (LVEF) < the
institutional lower limit of normal (LLN) or < 50% (whichever is higher)
- Patients must not have prior use of MEK or ERK 1/2 inhibitors
- Patients must not have a history of retinal vein occlusion (RVO) or central serous
retinopathy. Patients with visible retinal pathology as assessed by ophthalmologic
exam that is considered a risk factor for retinal vein thrombosis or central serous
retinopathy will be excluded
- Intraocular pressure is ≤ 21mm Hg as measured by tonography. Patients diagnosed with
glaucoma within 1 month prior to Step 1 registration are excluded
- Patients must not have leptomeningeal metastases or spinal cord compression due to
disease
- Patients must not have primary malignancy of the central nervous system
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
July 24, 2019
Completion date:
March 24, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06400225
