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

NCT04730349 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-03-24

Study results available
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Summary

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.

Conditions

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

Interventions

BIOLOGICAL

Nivolumab

Specified dose on specified days

BIOLOGICAL

NKTR-214

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2022-06-22
Completion
2022-06-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730349 on ClinicalTrials.gov