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Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors

NCT05407441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-13

No results posted yet for this 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

  • 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)
  • Epithelioid Sarcoma
  • Chordoma

Interventions

DRUG

Tazemetostat

oral, twice daily, dosage per protocol

DRUG

Nivolumab

IV, dosage and schedule per protocol

DRUG

Ipilimumab

IV, dosage and schedule per protocol

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Epizyme, Inc.

    collaborator INDUSTRY

  • Susan Chi, MD

    lead OTHER

Principal Investigators

  • Susan Chi, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2027-02-01
Completion
2029-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407441 on ClinicalTrials.gov