Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors (NCT05407441) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors
United States49 participantsStarted 2023-08-10
Plain-language 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)
Who can participate
Age range
6 Months – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis: Histologically confirmed tumors at diagnosis or at relapse (as applicable):
* Stratum A
* Atypical Teratoid Rhabdoid Tumor (ATRT)
* Other INI1- or SMARCA4-deficient primary CNS malignant tumors (with PI approval)
* Stratum B
* Malignant rhabdoid tumor (MRT)
* Rhabdoid tumor of the kidney (RTK)
* Epithelioid sarcoma
* Chordoma (poorly differentiated or de-differentiated)
* Other INI1- or SMARCA4-deficient malignant tumors (with PI approval)
* All subjects must have had tumor assessment at original diagnosis or relapse showing either of the following: Loss of INI1 confirmed by immunohistochemistry (IHC) OR molecular confirmation of tumor bi-allelic SMARCB1 (INI1) loss or mutation when INI1 IHC is equivocal or unavailable
* Loss of SMARCA4 confirmed by IHC OR molecular confirmation of tumor SMARCA4 loss or mutation (with PI approval) Reports confirming these findings (including tumor sequencing if available) will be reviewed by the Sponsor-Investigator, PI or designee for approval of eligibility prior to enrollment.
* Treatment status: All subjects must have completed planned upfront treatment for their disease for strata A1 or B1. Subjects need not have relapsed or have refractory disease to be eligible for this protocol.
* Disease Status: For subjects under consideration for strata A1 or B1, subjects must have evaluable disease Note: Leptomeningeal lesions/disease are allowed as evaluable disease.
* For relapsed/refractory subj…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Grade 3 or Higher Treatment-Related Toxicity
Timeframe: AE to be collected continuously after the patient has provided informed consent through up to 30 days after last dose of study treatment up to 5.5 years
2
Maximal Tolerated Dose (MTD)
Timeframe: Treatment duration is a median of N cycles range (t1 - t2). Treatment continues until disease progression or unacceptable toxicity up to 5.5 years