NCT04730349 - Bristol Myers Squibb™

Study Description

Brief 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.

Condition or Disease:Rhabdomyosarcoma
Relapsed, Refractory Malignant Neoplasms
Neuroblastoma
Miscellaneous Solid Tumors
Miscellaneous Brain Tumors
Medulloblastoma
Leukemia and Lymphoma
High-grade Glioma
Ewing Sarcoma
Ependymoma
Intervention/Treatment: Biological: Nivolumab
Biological: NKTR-214
Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

Study Type: Interventional
Estimated Enrollment: 228 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

Estimated Study Start Date: April 2021
Estimated Primary Completion Date: October 2025
Estimated Study Completion Date: October 2025

Arms and interventions

Arm	Intervention/treatment
Experimental: A1F Dosing schema	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: A1W Dosing schema	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: A2F Dosing schema	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: A2W Dosing schema	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B1 Neuroblastoma	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B2 Ewing sarcoma	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B3 Rhabdomyosarcoma	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B4 Miscellaneous solid tumors	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B5 NHL/leukemia	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B6 High-grade glioma	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B8 Ependymoma	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days
Experimental: Part B: Cohort B9 Miscellaneous brain tumors	Biological: Nivolumab Specified dose on specified days Biological: NKTR-214 Specified dose on specified days

Outcome Measures

Primary Outcome Measures: 1. Incidence of dose-limiting toxicities [ Time Frame: Up to 2 years and 100 days ]
Part A
Primary Outcome Measures: 2. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ]
Part A
Primary Outcome Measures: 3. Incidence of serious AEs (SAEs) [ Time Frame: Up to 2 years and 100 days ]
Part A
Primary Outcome Measures: 4. Incidence of drug-related AEs [ Time Frame: Up to 2 years and 100 days ]
Part A
Primary Outcome Measures: 5. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 100 days ]
Part A
Primary Outcome Measures: 6. Incidence of death [ Time Frame: Up to 2 years and 100 days ]
Part A
Primary Outcome Measures: 7. Pharmacokinetic (PK) parameters: Peak concentration [ Time Frame: Up to 2 years ]
Part A
Primary Outcome Measures: 8. Pharmacokinetic (PK) parameters: Trough concentration [ Time Frame: Up to 2 years ]
Part A
Primary Outcome Measures: 9. Pharmacokinetic (PK) parameters: Time-averaged concentration [ Time Frame: Up to 2 years ]
Part A
Primary Outcome Measures: 10. Pharmacokinetic (PK) parameters: Clearance (CL) [ Time Frame: Up to 2 years ]
Part A
Primary Outcome Measures: 11. Pharmacokinetic (PK) parameters: Volume of distribution (Vd) [ Time Frame: Up to 2 years ]
Part A
Primary Outcome Measures: 12. Investigator-assessed objective response rate (ORR) [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 1. Incidence of AEs [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 2. Incidence of SAEs [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 3. Incidence of drug-related AEs [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 5. Incidence of death [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 6. Incidence of laboratory abnormalities: Hematology tests [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 7. Incidence of laboratory abnormalities: Clinical chemistry tests [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 8. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
Part B
Secondary Outcome Measures: 9. Overall survival (OS) [ Time Frame: Up to 5 years ]
Part B

Eligibility Criteria

Ages Eligible for Study: up to 30 / (18 to 64 years)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 NOTE: other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Maryland
Local Institution
Baltimore

United States, Missouri
Local Institution
Saint Louis

Australia, New South Wales
Local Institution
Randwick

Australia, Queensland
Local Institution
South Brisbane

Australia, Victoria
Local Institution
Parkville

Australia, Western Australia
Local Institution
Nedlands

France
Local Institution
Lyon

France
Local Institution
Marseille

France
Local Institution
Paris

France
Local Institution
Villejuif

Germany
Local Institution
Greifswald

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Valencia

Sponsors and Collaborators

Bristol-Myers Squibb

Nektar Therapeutics

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04730349 History of Changes
Other Study ID Numbers: CA045-020, 2020-000854-85
First Posted: January 29, 2021 Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: Rhabdomyosarcoma
Pediatric malignancy
Pediatric cancer
Opdivo®
Non-rhabdomyosarcoma soft-tissue sarcomas
NIVO
NKTR-214
Nivolumab
Neuroblastoma
Miscellaneous solid tumors
Miscellaneous brain tumors
Melanoma
Medulloblastoma Leukemia and lymphoma
IL-2 Receptor Agonist
IL-2
Immunotherapy
High-grade glioma (HGG)/diffuse intrinsic pontine glioma (DIPG)
Ewing sarcoma
Ependymoma
Check point inhibitor
CD122-Biased Cytokine
CD122-Biased Agonist
Bempegaldesleukin
BEMPEG
B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL)
Additional relevant MeSH terms: Medulloblastoma
Sarcoma, Ewing
Ependymoma
Rhabdomyosarcoma
Neuroblastoma
Brain Neoplasms Glioma
Sarcoma
Leukemia
Neoplasms
Lymphoma

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Condition Categories

Clinical Trials of Interest

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (PIVOT IO 020)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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Condition Categories

Clinical Trials of Interest

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (PIVOT IO 020)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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