Ulixertinib

DRUG12 trials

Sponsors

National Cancer Institute (NCI), UNC Lineberger Comprehensive Cancer Center, University of Utah, BioMed Valley Discoveries, Inc, M.D. Anderson Cancer Center

Conditions

Advanced LymphomaAdvanced Malignant Solid NeoplasmAdvanced Solid TumorAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaBRAF Gene AlterationBRAF Gene MutationBladder Carcinoma

Early Phase 1

Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas

RecruitingNCT05804227

M.D. Anderson Cancer CenterGliomas

Start: 2023-04-20End: 2027-09-22Target: 40Updated: 2026-02-27

Phase 1

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

RecruitingNCT03454035

UNC Lineberger Comprehensive Cancer CenterMelanoma, Pancreatic Cancer, Tumor, Solid

Start: 2018-01-30End: 2026-11-24Target: 45Updated: 2025-09-11

Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

CompletedNCT04145297

University of UtahGastrointestinal Neoplasms

Start: 2020-03-17End: 2022-08-18Updated: 2024-11-18

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

RecruitingNCT05985954

M.D. Anderson Cancer CenterMetastatic Colorectal Cancer

Start: 2024-01-18End: 2028-03-28Target: 27Updated: 2026-03-12

A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis

RecruitingNCT06773195

Memorial Sloan Kettering Cancer CenterMyelofibrosis

Start: 2025-01-07End: 2028-01-01Target: 37Updated: 2026-04-03

Phase 2

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Active, not recruitingNCT02465060

National Cancer Institute (NCI)Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma +49

Start: 2015-08-17End: 2026-12-31Target: 6452Updated: 2026-04-03

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Active, not recruitingNCT03155620

National Cancer Institute (NCI)Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma +42

Start: 2017-07-31End: 2027-01-06Updated: 2026-02-10

Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Active, not recruitingNCT03698994

National Cancer Institute (NCI)Advanced Malignant Solid Neoplasm, Recurrent Ependymal Tumor, Recurrent Ewing Sarcoma +33

Start: 2018-11-14End: 2026-03-30Updated: 2025-12-03

Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

TerminatedNCT04488003

BioMed Valley Discoveries, IncAdvanced Solid Tumor, BRAF Gene Alteration, BRAF Gene Mutation +6

Start: 2021-01-07End: 2023-05-23Updated: 2024-06-04

Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

TerminatedNCT05221320

BioMed Valley Discoveries, IncGastrointestinal Cancer, Tumor, Solid

Start: 2022-05-26End: 2024-07-14Updated: 2025-09-25

Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)

Active, not recruitingNCT06400225

National Cancer Institute (NCI)Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma +2

Start: 2019-07-24End: 2026-12-31Target: 35Updated: 2025-11-04

Ulixertinib in People With Histiocytic Neoplasms

RecruitingNCT06411821

Memorial Sloan Kettering Cancer CenterHistiocytic Neoplasms

Start: 2024-05-07End: 2027-05-31Target: 38Updated: 2025-12-15

Related Papers

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A phase 2 basket trial of ulixertinib (BVD-523) in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations (BVD-523-HCQ).

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Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology

npj Precision Oncology2022-10-2715 citations

Abstract 2438: Determining the role of non-mutated C-Raf kinase in metastatic disease

Cancer Research2022-06-15

Abstract 4022: ERK1/2 inhibitor ulixertinib demonstrates activity in atypical (non-V600) BRAF mutant models

Cancer Research2022-06-15

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