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

Phase 2TerminatedNCT04730349

Bristol-Myers Squibb15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ependymoma Ewing Sarcoma High-grade Glioma Leukemia and Lymphoma Medulloblastoma Miscellaneous Brain Tumors

Eligibility

Sex: ALLMax age: 30 Years

Medical Language ↔ Plain English

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 Other protocol-defined inclusion/exclusion criteria apply

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

...and 8 more locations

Outcomes

Primary Outcomes

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).

Time frame: From first dose to 42 days after first dose

Number of Participants With Adverse Events (AEs) - Part A

Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.