A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04730349
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Ependymoma
  • Ewing Sarcoma
  • High-grade Glioma
  • Leukemia and Lymphoma
  • Medulloblastoma
  • Miscellaneous Brain Tumors
  • Miscellaneous Solid Tumors
  • Neuroblastoma
  • Relapsed, Refractory Malignant Neoplasms
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • NKTR-214 — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

Key Dates

Start date
Jun 3, 2021
Status verified
Mar 2023
Primary completion
Jun 22, 2022
Completion
Jun 22, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: A1W Dosing schema
  • Experimental: A1F Dosing schema
  • Experimental: A2W Dosing schema
  • Experimental: A2F Dosing schema
  • Experimental: Part B: Cohort B1 Neuroblastoma
  • Experimental: Part B: Cohort B2 Ewing sarcoma
  • Experimental: Part B: Cohort B3 Rhabdomyosarcoma
  • Experimental: Part B: Cohort B4 Miscellaneous solid tumors
  • Experimental: Part B: Cohort B5 NHL/leukemia
  • Experimental: Part B: Cohort B6 High-grade glioma
  • Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
  • Experimental: Part B: Cohort B8 Ependymoma
  • Experimental: Part B: Cohort B9 Miscellaneous brain tumors

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A [ Time Frame: From first dose to 42 days after first dose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Local Institution - 0029Little RockArkansas72202-
Local Institution - 0011St LouisMissouri63110-

Find similar trials in Little Rock, AR

By condition
Brain cancerNeuroblastoma
By specialty
OncologyNeuro-oncologyPediatric oncology
By research site
Local Institution - 0029· Little Rock, ARLocal Institution - 0011· St Louis, MO

Related Studies