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 at 2 sites in 2 countries. 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
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Among 33 studies in Desmoid Tumors with a site in United States — 6 open to participants now, 9 under way, 1 of them phase 3. Desmoid Tumors · United States.
Among the 33 studies in Desmoid Tumors with a site in United States, this one is one of 2 of another kind, and was the 28th registered.
71 studies on the registry are indexed under Desmoid Tumors; 21 are open to participants now.
Browse Desmoid Tumors studies →6 of the 33 studies in Desmoid Tumors with a site in United States are open now. Recruiting first, the newest first:
Nam Bui · Sites in United States
Ages 18+
Parabilis Medicines, Inc. · Sites in United States, Australia
Ages 18+
Children's Oncology Group · Sites in United States
Ages 12 mo–30 yrs
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Children's Oncology Group · Sites in United States, Australia, Canada and 3 more countries
Ages up to 25
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Desmoid Tumors studies recruiting now, 13 (76%) set no upper age limit and 4 (24%) stop at 75 or younger; 6 take children under 18; none take healthy volunteers.
This study: all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 13 · Phase 3 4
First in 1991; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 43 across the 24 interventional studies, 150 across the 7 observational. Of the 20 that completed or were terminated, 9 (45%) have results posted.
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6 of 33 have an industry lead sponsor. The 10 most frequent:
This study is registered under SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, one of the names counted as Merck KGaA, Darmstadt, Germany. Under that name alone:
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.
Merck KGaA, Darmstadt, Germany has 4 studies filed under Desmoid Tumors — fewer than ten, so there is no comparison to draw.
2 of the studies in Desmoid Tumors with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04281381Memorial Sloan Kettering Cancer CenterObserving People With Desmoid-Type Fibromatosis | 2027-02-19 |
| NCT05919264Parabilis Medicines, Inc.FOG-001 in Locally Advanced or Metastatic Solid Tumors | 2027-04-01 |
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Among the 33 studies in Desmoid Tumors with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Inclusion Criteria:
Patients will receive nirogacestat tablets to be taken orally.
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 ↗
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SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany →