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

First listed
Jun 7, 2022
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

Related Studies