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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

NCT04730349•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 30 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \< 18 years for Part A and Part B
•Age up to 30 years for Part B Cohorts B2, B3 and B4
•Must have received standard of care therapy and there must be no potentially curative treatment available
•Histologically confirmed with malignant neoplasms that are refractory, relapsed, or curative treatments are lacking
•Must have measurable or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for solid tumors, Response Assessment in Neuro-Oncology (RANO) or Response Assessment in Pediatric Neuro-Oncology (RAPNO) for central nervous system tumors, International Pediatric Non-Hodgkin Lymphoma Response Criteria for non-Hodgkin lymphoma (NHL), revised International Neuroblastoma Response Criteria (INRC) for neuroblastoma, modified National Comprehensive Cancer Network (NCCN) Criteria for acute lymphoblastic leukemia, and modified Cheson et al International Working Group criteria for acute myeloid leukemia
•Lansky play score for age ≤ 16 years or Karnofsky performance score for age \> 16 years assessed within 2 weeks of enrollment must be ≥ 60

Exclusion Criteria

•Osteosarcoma, T-cell/Natural Killer (NK) cell leukemia/lymphoma, and Hodgkin's lymphoma
•Need for \> 2 antihypertensive medications for management of hypertension (including diuretics)
•Known cardiovascular history, including unstable or deteriorating cardiac disease, within the previous 12 months prior to screening
•Inadequately treated adrenal insufficiency
•Active, known, or suspected autoimmune disease
•Active infection requiring systemic therapy within 14 days prior to first dose
•Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
•Prior allogeneic stem cell transplant
•Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection either suspected or confirmed within 4 weeks prior to screening

Locations (18)

Local Institution - 0029

Little Rock, Arkansas, United States

Local Institution - 0011

St Louis, Missouri, United States

Local Institution - 0001

Randwick, New South Wales, Australia

Local Institution

South Brisbane, Queensland, Australia

Local Institution - 0002

Parkville, Victoria, Australia

Local Institution - 0003

Perth, Western Australia, Australia

Local Institution - 0013

Villejuif, Val-de-Marne, France

Local Institution - 0014

Lyon, France

Local Institution - 0016

Marseille, France

Local Institution - 0015

Paris, France

Key Dates

Start Date

June 3, 2021

Primary Completion Date

June 22, 2022

Completion Date

June 22, 2022

Last Updated

March 24, 2023

Enrollment

ACTUAL participants

Conditions

EpendymomaEwing SarcomaHigh-grade GliomaLeukemia and LymphomaMedulloblastomaMiscellaneous Brain TumorsMiscellaneous Solid TumorsNeuroblastomaRelapsed, Refractory Malignant NeoplasmsRhabdomyosarcoma

Interventions

Nivolumab

BIOLOGICAL

NKTR-214

BIOLOGICAL

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

NCT03715933

Ewing Sarcoma

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RECRUITINGPHASE1/PHASE2

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

NCT06541262

NeuroblastomaEwing Sarcoma+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Lurbinectedin in FET-Fused Tumors

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

Observational Study on Skeletal Ewing's Sarcoma