RecruitingPhase 1Phase 2NCT05407441

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

TAZNI: A Phase I/II Combination Trial of Tazemetostat With Nivolumab and Ipilimumab for Children With INI1-Negative or SMARCA4-Deficient Tumors


Sponsor

Susan Chi, MD

Enrollment

49 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

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)


Eligibility

Min Age: 6 MonthsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immune-boosting drugs — tazemetostat and nivolumab/ipilimumab — for rare and aggressive tumors that are missing a protein called INI1 or SMARCA4. These are typically very hard-to-treat childhood and adult cancers. **You may be eligible if...** - You or your child has been diagnosed with a tumor confirmed to lack INI1 or SMARCA4 (e.g., atypical teratoid rhabdoid tumor, malignant rhabdoid tumor, kidney rhabdoid tumor, epithelioid sarcoma, chordoma, or similar) - The tumor has been assessed at diagnosis or relapse - Standard treatments have not worked or are not available **You may NOT be eligible if...** - The tumor does not have the required molecular marker (INI1-negative or SMARCA4-deficient) - You have certain other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTazemetostat

oral, twice daily, dosage per protocol

DRUGNivolumab

IV, dosage and schedule per protocol

DRUGIpilimumab

IV, dosage and schedule per protocol


Locations(3)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Texas Children's Hospital

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05407441