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

First listed
Jun 4, 2020
Start date
Aug 14, 2020
Status verified
Jun 2026
Primary completion
Jul 17, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (actual)
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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