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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 Epithelioid Sarcoma, sponsored by Susan Chi, MD.

Recruiting
Registry status
Phase 1
Development phase
49
Enrollment target
3
Study locations

NCT05407441 is a Phase 1 study of Chordoma and Epithelioid Sarcoma 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.

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The verdict

NCT05407441, a Phase 1 study of Chordoma and Epithelioid Sarcoma, 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)

Conditions Studied

Chordoma Epithelioid Sarcoma Atypical Teratoid Rhabdoid Tumor INI1 (SMARCB1)-Deficient Primary CNS Malignant Tumors SMARCA4-deficient Primary CNS Malignant Tumors Malignant Rhabdoid Tumor (MRT) Rhabdoid Tumor of the Kidney (RTK)

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

FieldValue
Enrollment Target 49 participants
Start Date 2023-08-10
Est. Completion 2029-02-01
Phase Phase 1

Sponsor

Susan Chi, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05407441

The ClinicalTrials.gov registry entry for NCT05407441 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 84-participant average among 15 other Chordoma trials with a reported enrollment target (42% lower). The listed sponsor is Susan Chi, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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, Epithelioid Sarcoma, Atypical Teratoid Rhabdoid Tumor, 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.