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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Susan Chi, MD
Study ID
NCT05407441
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Tazemetostat — DRUG
    oral, twice daily, dosage per protocol
  • Nivolumab — DRUG
    IV, dosage and schedule per protocol
  • Ipilimumab — DRUG
    IV, dosage and schedule per protocol

Study Details

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)

Key Dates

Start date
Aug 10, 2023
Status verified
Apr 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2029

Study Design

Enrollment
49 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I a: DOSE ESCALATION (STRATUM A, ATRT and primary CNS malignant tumor, INI/SMARCA4-deficient)
    Part 1 will be two concurrent "rolling six" phase 1 studies starting at a different tazemetostat dose for each stratum), with one dose escalation and one dose de-escalation planned. All subjects will receive the same nivolumab and ipilimumab doses and dosing schedule
  • Experimental: Phase I b: DOSE ESCALATION (STRATUM B, NON-ATRT, NON-CNS)
    Part 1 will be two concurrent "rolling six" phase 1 studies starting at a different tazemetostat dose for each stratum), with one dose escalation and one dose de-escalation planned. All subjects will receive the same nivolumab and ipilimumab doses and dosing schedule
  • Experimental: EXP A1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A1)
    Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2. Part 2 will consist of 3 substrata per stratum based on their disease status
  • Experimental: EXP A2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A2)
    Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2. Part 2 will consist of 3 substrata per stratum based on their disease status
  • Experimental: EXP A3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA A3)
    Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2. Part 2 will consist of 3 substrata per stratum based on their disease status
  • Experimental: EXP B1: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B1)
    Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2. Part 2 will consist of 3 substrata per stratum based on their disease status
  • Experimental: EXP B2: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B2)
    Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2. Part 2 will consist of 3 substrata per stratum based on their disease status
  • Experimental: EXP B3: TAZEMETOSTAT + NIVOLUMAB + IPILIMUMAB DOSE EXPANSION (SUBSTRATA B3)
    Once the MTD or RP2D of the combination is determined for each stratum, the Part 2 portion will open for that stratum, with subjects from Part 1 who are treated at the RP2D to be counted towards the enrollment numbers for Part 2. Part 2 will consist of 3 substrata per stratum based on their disease status

Primary Outcome Measure

Incidence of Grade 3 or Higher Treatment-Related Toxicity [ Time Frame: 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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MATexas Children's Hospital· Houston, TX

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