Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers

Part of paid clinical trials in San Francisco, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04416568
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Atypical Teratoid/Rhabdoid Tumor
  • Chordoma (Poorly Differentiated or De-differentiated)
  • Epithelioid Sarcoma
  • Malignant Rhabdoid Tumor
  • Other INI1 Negative Tumors (With PI Approval)
  • Other SMARCA4-deficient Malignant Tumors (With PI Approval)
  • Rhabdoid Tumor of the Kidney

Eligibility Criteria

Sex
ALL
Age
6 Months - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Combination Therapy: Nivolumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles. Monotherapy: Starting with cycle 5 nivolumab at predetermined dosage on day 1 and day 15 of a 28-day cycle
  • Ipilimumab — DRUG
    Combination Therapy: Ipilimumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles

Study Details

This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.

Key Dates

Start date
Aug 14, 2020
Status verified
Dec 2025
Primary completion
Jul 17, 2025
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: Solid Tumor (Stratum 1)
    * Patients will receive combination therapy with nivolumab at a predetermined dose and ipilimumab at a predetermined dose day 1 of a 21-day cycle for 4 cycles * Starting with cycle 5, patients will receive nivolumab monotherapy at a predetermined dose on day 1 and day 15 of a 28-day cycle * Patients with INI1-negative relapsed or refractory extracranial solid tumors
  • Experimental: CNS (Stratum 2)
    * Patients will receive combination therapy with nivolumab at a predetermined dose and ipilimumab at a predetermined dose day 1 of a 21-day cycle for 4 cycles * Starting with cycle 5, patients will receive nivolumab monotherapy at a predetermined dose on day 1 and day 15 of a 28-day cycle * Patients with INI1-negative relapsed or refractory CNS tumors

Primary Outcome Measure

Objective Overall Response Rate (Stratum 1) [ Time Frame: 12 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalSan FranciscoCalifornia94158-
Children's Healthcare of Atlanta-EglestonAtlantaGeorgia30322-
Children's Healthcare of Atlanta-Scottish RiteAtlantaGeorgia30342-
Boston Children's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in San Francisco, CA

By research site
UCSF Benioff Children's Hospital· San Francisco, CAChildren's Healthcare of Atlanta-Egleston· Atlanta, GAChildren's Healthcare of Atlanta-Scottish Rite· Atlanta, GABoston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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