12 recruiting, 7 completed, 4 terminated, 2 not yet recruiting. 18 Phase 1, 18 Phase 2, 1 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma mirdametinib with radiation, mirdametinib - Neurofibromatosis 1 (NF1) | Phase 2 | Not yet recruiting | University of Alabama at Birmingham | 55 | 2027-01-01 | 2026-10-05 |
| A Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas Mirdametinib - Neurofibromatosis Type 1-Associated Plexiform Neurofibromas | Phase 1 | Not yet recruiting | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | 6 | 2026-12-09 | 2026-10-21 |
| Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma Mirdametinib, Sirolimus - Multiple Myeloma, Relapsed and/or Refractory Multiple Myeloma (RRMM) | Phase 1 / Phase 2 | Suspended | National Cancer Institute (NCI) | 54 | 2026-10-27 | 2026-10-22 |
| A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants Mirdametinib, Probenecid - Healthy | Phase 1 | Recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 17 | 2026-09-25 | 2026-10-09 |
| Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography - Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma | Phase 2 | Recruiting | National Cancer Institute (NCI) | 20 | 2026-05-27 | 2026-10-06 |
| A Study of Mirdametinib in People With Central Nervous System Tumors Mirdametinib - Central Nervous System Tumors, Glioma | Phase 1 / Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 26 | 2026-04-10 | 2026-09-03 |
| Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK Mirdametinib - Pediatric Low-grade Glioma | Phase 1 / Phase 2 | Recruiting | St. Justine's Hospital | 50 | 2026-01-12 | 2026-10-16 |
| To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants Mirdametinib, Mirdametinib and Carbamazepine - Healthy, Volunteer | Phase 1 | Completed | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | 36 | 2025-12-15 | 2026-05-08 |
| A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST] mirdametinib and vorinostat - Primary Malignant Peripheral Nerve Sheath Tumors | Early Phase 1 | Recruiting | University of Minnesota | 8 | 2025-11-20 | 2026-05-29 |
| Mirdametinib in Patients With Advanced NF1-mutant Melanoma Mirdametinib - Advanced Unresectable Melanoma, Metastatic Melanoma | Phase 2 | Recruiting | Kevin Kim, MD | 10 | 2025-10-13 | 2025-11-19 |
| Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib Mirdametinib (MEK Inhibitor) - Healthy, Hepatic Impairment | Phase 1 | Recruiting | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | 32 | 2025-04-24 | 2026-10-14 |
| A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma Mirdametinib, Palbociclib - Well Differentiated Liposarcoma, Dedifferentiated Liposarcoma | Phase 1 / Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 54 | 2025-02-19 | 2026-09-16 |
| A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations Alpelisib, Mirdametinib - Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation | Phase 2 | Recruiting | Murdoch Childrens Research Institute | 50 | 2024-09-13 | 2026-05-05 |
| Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF). Mirdametinib - NF1, Cutaneous Neurofibroma | Phase 1 / Phase 2 | Recruiting | Johns Hopkins University | 24 | 2024-02-12 | 2026-04-13 |
| Mirdametinib in Histiocytic Disorders Mirdametinib - Langerhans Cell Histiocytosis (LCH), Juvenile Xanthogranuloma (JXG) | Phase 2 | Recruiting | Children's Hospital Medical Center, Cincinnati | 40 | 2024-02-05 | 2026-09-21 |
| Mirdametinib + BGB-3245 in Advanced Solid Tumors Mirdametinib 2mg, BGB-3245 5mg, Mirdametinib 3mg - Advanced Solid Tumor | Phase 1 / Phase 2 | Terminated | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | 23 | 2023-02-03 | 2026-08-20 |
| A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer Mirdametinib, Fulvestrant - Breast Cancer, Breast Cancer Stage IV | Phase 1 / Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 6 | 2021-09-14 | 2025-05-23 |
| SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Mirdametinib - Low-Grade Glioma, Recurrent Low-Grade Glioma | Phase 1 / Phase 2 | Recruiting | St. Jude Children's Research Hospital | 132 | 2021-06-21 | 2026-09-11 |
| MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas Mirdametinib (PD-0325901) oral capsule or dispersible tablet - Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1) | Phase 2 | Active not recruiting | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | 114 | 2019-09-29 | 2026-10-06 |
| Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors Lifirafenib, mirdametinib - Solid Tumor, Adult | Phase 1 | Completed | BeiGene | 91 | 2019-05-01 | 2026-01-07 |
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Neurofibromatoses (3) · Neurofibromatosis 1 (3) · Breast Neoplasms (2) · Colorectal Neoplasms (2) · Glioma (2) · Melanoma (2) · Neurofibroma (2) · Neurofibroma, Plexiform (2) · Arteriovenous Malformations (1) · Astrocytoma (1) · Carcinoma, Non-Small-Cell Lung (1) · Central Nervous System Neoplasms (1) · Colonic Neoplasms (1) · Ganglioglioma (1) · Ganglioneuroma (1)
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany (6) · Memorial Sloan Kettering Cancer Center (3) · Pfizer (3) · National Cancer Institute (NCI) (2) · University of Alabama at Birmingham (2) · BeiGene (1) · Children's Hospital Medical Center, Cincinnati (1) · Dana-Farber Cancer Institute (1) · Johns Hopkins University (1) · Kevin Kim, MD (1) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (1) · Murdoch Childrens Research Institute (1) · Sharp HealthCare (1) · St. Jude Children's Research Hospital (1) · St. Justine's Hospital (1)
United States (23) · Australia (3) · Germany (3) · Canada (2) · Italy (1) · Netherlands (1) · Spain (1) · United Kingdom (1)
Allison Bartlett, MD (1) · Anna Piotrowski, MD (1) · Anna Vinitsky, MD, MS (1) · Ashish Kumar, MD, PhD (1) · Carlos Romo, MD (1) · Elizabeth M Hill, M.D. (1) · Ezra Rosen, MD, PhD (1) · Geoffrey Shapiro, MD. Ph.D (1) · Giles W. Robinson, MD (1) · Girish Dhall, MD (1) · Jennifer R Brown (1) · Lydia Pathmanathan, MBBS, FRACP. (1)
PMID 33507822, PMID 19841428, PMID 21516509, PMID 22159586, PMID 27573663, PMID 31151904, PMID 32147669, PMID 32182156, PMID 32502457, PMID 39514826, PMID 40241281, PMID 8487049
2025 (1), UM1CA186709 (1)