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NCT06411821
Phase 2 Trial of Ulixertinib for Patients With Histiocytic Neoplasms
Phase 2 trial testing Ulixertinib in Histiocytic Neoplasms in 38 participants. Currently enrolling.
1 May 2027
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 7 May 2024 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 May 2027 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Ulixertinib (ulixertinib) — full drug profile →
Conditions studied
- Histiocytic Neoplasms — all drugs for Histiocytic Neoplasms →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
12 and older, any sex, with Histiocytic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
overall response rate
Time frame: 1 year
Best overall response by PET is defined as the best response, according to PRC, recorded from the first day of study treatment until disease progression, recurrence, or death. Complete response Normalization of all lesions' (target and nontarget) SUV to background SUVliver (or SUVbrain for brain lesions) Partial response ≥50% decrease from baseline in sum of SUVs of all target lesions relative to
Sponsor's own description
The researchers are doing this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
RAF-independent MEK mutations drive refractory histiocytic neoplasms but respond to ERK inhibition.
Diamond EL, Emile JF, Fujino T, Haroche J, et al · · 2026 · cited 3× · PMID 41135521 · DOI 10.1016/j.ccell.2025.09.014 -
Histiocyte Society blueprint for non-Langerhans cell histiocytosis research: unraveling complex diseases through collaboration.
Hershkovitz-Rokah O, Abeykoon JP, Ravindran A, Goyal G. · · 2025 · cited 2× · PMID 41178439 · DOI 10.3324/haematol.2024.286479
Verify or expand the search:
- PubMed search for NCT06411821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ulixertinib
Trials testing the same drug.
- NCT05985954 — Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in P · Phase 1 · recruiting
- NCT05804227 — Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas · EARLY_PHASE1 · recruiting
- NCT05221320 — Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies · Phase 2 · terminated
- NCT04488003 — Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations · Phase 2 · terminated
- NCT04145297 — Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas · Phase 1 · completed
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06411821 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 27 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06411821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing