A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03130959
Phase
PHASE2
Status
Completed

Conditions

  • Various Advanced Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.

Key Dates

Start date
Jun 12, 2017
Status verified
Jul 2022
Primary completion
Mar 10, 2020
Completion
Jan 17, 2022

Study Design

Enrollment
166 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module A
  • Experimental: Module B

Primary Outcome Measure

Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: up to 6 weeks post-dosing ]

Locations (14)

FacilityCityStateZIPSite coordinators
Local Institution - 0057Los AngelesCalifornia90027-
Local Institution - 0016AuroraColorado80045-
Local Institution - 0046GainesvilleFlorida32611-
Local Institution - 0011ChicagoIllinois60611-2605-
Local Institution - 0005BaltimoreMaryland21287-
Local Institution - 0043BostonMassachusetts02215-
Local Institution - 0044St LouisMissouri63110-
Local Institution - 0004New YorkNew York10021-
Local Institution - 0017New YorkNew York10032-
Cincinnati Children'S Hospital Medical CenterCincinnatiOhio45229-
Local Institution - 0066PhiladelphiaPennsylvania19104-
Local InstitutionCharlestonSouth Carolina29425-
Local Institution - 0012MemphisTennessee38105-
Local Institution - 0042HoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Local Institution - 0057· Los Angeles, CALocal Institution - 0016· Aurora, COLocal Institution - 0046· Gainesville, FLLocal Institution - 0011· Chicago, ILLocal Institution - 0005· Baltimore, MDLocal Institution - 0043· Boston, MA