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NCT05407441 · ClinicalTrials.gov registry record · Phase 1
Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors
A Phase 1 study of Chordoma and Atypical Teratoid/Rhabdoid Tumor, sponsored by Susan Chi, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 3
- Study locations
NCT05407441: Recruiting Phase 1 study of Chordoma and Atypical Teratoid/Rhabdoid Tumor, sponsored by Susan Chi, MD.
NCT05407441 is a Phase 1 study of Chordoma and Atypical Teratoid/Rhabdoid Tumor that is actively recruiting participants, run by Susan Chi, MD. The registered enrollment target is 49 participants, below the 84-participant average among 15 other Chordoma trials with a reported enrollment target (42% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05407441, a Phase 1 study of Chordoma and Atypical Teratoid/Rhabdoid Tumor, is actively recruiting participants, sponsored by Susan Chi, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 3
- Study locations
Study Summary
This research study involves a combination of three drugs given together as a possible treatment for malignant rhabdoid tumor, atypical teratoid rhabdoid tumor, epithelioid sarcoma, chordoma or other tumors that are deficient in one of two possible proteins, either INI-1 (SMARCB1) or SMARCA4. The names of the study drugs involved in this study are: * Tazemetostat (TAZVERIK) * Nivolumab (OPDIVO) * Ipilimumab (YERVOY)
Primary Outcome
All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAE v5 as reported on case report forms will be counted. Incidence is the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Tazemetostat
Study Locations (3)
Massachusetts
- Boston Children's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 1 |
What NCT05407441 shows while recruiting
NCT05407441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 84-participant average among 15 other Chordoma trials with a reported enrollment target (42% lower).
The record links to 7 conditions, with Chordoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05407441 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT05407441 about?
NCT05407441 is a clinical study titled "Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors". This research study involves a combination of three drugs given together as a possible treatment for malignant rhabdoid tumor, atypical teratoid rhabdoid tumor, epithelioid sarcoma, chordoma or other tumors that are deficient in one of two possible proteins, either INI-1 (SMARCB1) or SMARCA4. The n...
What is the current status of trial NCT05407441?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2023-08-10. Estimated completion is 2029-02-01.
What conditions does trial NCT05407441 study?
This clinical trial studies the following conditions: Chordoma, Atypical Teratoid/Rhabdoid Tumor, Epithelioid Sarcoma, INI1 (SMARCB1)-Deficient Primary CNS Malignant Tumors, SMARCA4-deficient Primary CNS Malignant Tumors.
What interventions are being tested in trial NCT05407441?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Tazemetostat (DRUG).
Who is sponsoring clinical trial NCT05407441?
This trial is sponsored by Susan Chi, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05407441 being conducted?
This trial has 3 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chordoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05407441's enrollment target sits among peer trials
49 6th of 15 higher than 10 of 15 other Chordoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chordoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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