ClinicalTrials.gg
AvailableNCT05028166Updated Oct 5, 2026

Individual Patient Compassionate Use of Mirdametinib

An expanded access record providing Mirdametinib (MEK Inhibitor) in Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, Histiocytic Neoplasm and Other MAP-K Pathway Driven Diseases, sponsored by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany. Available at 2 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany (part of Merck KGaA, Darmstadt, Germany) · Expanded access

Updated Oct 5, 2026First sites in Germany and United States2 sites addedGo to Updates ↓
Study type
Expanded access
Access type
Individual patients
Ages
2 Years and older
Sex
All
01

Study summary

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.

02

Conditions studied

  • Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
  • Histiocytic Neoplasm
  • Other MAP-K Pathway Driven Diseases

Keywords

  • RASopathies
  • NF1
  • Neurofibromatosis
  • Plexiform Neurofibromas
  • Langerhans
03

In context

Neurofibromatoses

57 studies on the registry are indexed under Neurofibromatoses; 14 are open to participants now.

Browse Neurofibromatoses studies →

Lead sponsor

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

First submitted before SpringWorks Therapeutics, Inc. became part of Merck KGaA, Darmstadt, Germany.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All

Eligibility criteria

Inclusion Criteria:

  • Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
  • Patient does not qualify to participate in an ongoing clinical trial.
05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

06

Where to request access

2 of 2 sites recruiting
  • Please Contact U.S. Medical Information
    Billerica, Massachusetts 01821, United States
    Available
  • Please Contact the Communication Center
    Darmstadt, 64293, Germany
    Available
07

References and documents

08

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added — first sites in Germany and United States
Show 2 added (1 United States, 1 Germany)
  • Please Contact U.S. Medical Information · Billerica, United States
  • Please Contact the Communication Center · Darmstadt, Germany
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    2 sites added — first sites in Germany and United States
    Show 2 added (1 United States, 1 Germany)
    • Please Contact U.S. Medical Information · Billerica, United States
    • Please Contact the Communication Center · Darmstadt, Germany
    + 3 other changes: verification date, contact details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05028166
Responsible party
Sponsor
First posted
Aug 31, 2021
Last update
Oct 5, 2026

Study contacts

US Medical Information
Contact
eMediUSA@emdserono.com
888-275-7376
Contact Early Access
Contact
earlyaccess@emdgroup.com
View the source record on ClinicalTrials.gov ↗

Requesting access

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