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AvailableNCT05041036Updated May 8, 2026

Individual Patient Compassionate Use of Nirogacestat

An expanded access record providing Nirogacestat (Gamma Secretase Inhibitor) in Desmoid Tumor and NOTCH Gene Mutation Positive Tumors, sponsored by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany. Available. Per ClinicalTrials.gov, last updated 2026-05-08.

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

Study type
Expanded access
Access type
Individual patients
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

  • Desmoid Tumor
  • NOTCH Gene Mutation Positive Tumors

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Keywords

  • desmoid tumor
  • aggressive fibromatosis
  • desmoid fibromatosis
  • Notch-positive tumors
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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.
04

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugNirogacestat (Gamma Secretase Inhibitor)

    Patients will receive nirogacestat tablets to be taken orally.

05

Where to request access

No study locations are listed for this record.

06

Registry details

Key details

Study ID
NCT05041036
Lead sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Sep 10, 2021
Last update
May 8, 2026

Study contacts

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

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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