A Study of Bempegaldesleukin in Combination with Nivolumab in Children, Adolescents and Young Adults with Recurrent or Treatment-resistant Cancer (PIVOT IO 020)

Phase 1

• Conditions: Recurrent or Refractory pediatric cancer; MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLGTClassification code 10025322Term: Lymphomas non-Hodgkin's unspecified histologySystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10027107Term: MedulloblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2020-000854-85-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 228

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 194
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Osteosarcoma, T-cell/NK-cell leukemia/lymphoma, and Hodgkin 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
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified