PIVOT IO 020: A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
Study Details
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 | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A1W Dosing schema
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: A1F Dosing schema
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: A2W Dosing schema
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: A2F Dosing schema
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B1 Neuroblastoma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B2 Ewing sarcoma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B3 Rhabdomyosarcoma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B4 Miscellaneous solid tumors
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B5 NHL/leukemia
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B6 High-grade glioma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B7 Medulloblastoma and Embryonal Tumors
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B8 Ependymoma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Experimental: Part B: Cohort B9 Miscellaneous brain tumors
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: NKTR-214
Specified dose on specified days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose-limiting toxicities [Up to 2 years and 100 days]
Part A
- Incidence of adverse events (AEs) [Up to 2 years and 100 days]
Part A
- Incidence of serious AEs (SAEs) [Up to 2 years and 100 days]
Part A
- Incidence of drug-related AEs [Up to 2 years and 100 days]
Part A
- Incidence of AEs leading to discontinuation [Up to 2 years and 100 days]
Part A
- Incidence of death [Up to 2 years and 100 days]
Part A
- Pharmacokinetic (PK) parameters: Peak concentration [Up to 2 years]
Part A
- Pharmacokinetic (PK) parameters: Trough concentration [Up to 2 years]
Part A
- Pharmacokinetic (PK) parameters: Time-averaged concentration [Up to 2 years]
Part A
- Pharmacokinetic (PK) parameters: Clearance (CL) [Up to 2 years]
Part A
- Pharmacokinetic (PK) parameters: Volume of distribution (Vd) [Up to 2 years]
Part A
- Investigator-assessed objective response rate (ORR) [Up to 5 years]
Part B
Secondary Outcome Measures
- Incidence of AEs [Up to 5 years]
Part B
- Incidence of SAEs [Up to 5 years]
Part B
- Incidence of drug-related AEs [Up to 5 years]
Part B
- Incidence of AEs leading to discontinuation [Up to 5 years]
Part B
- Incidence of death [Up to 5 years]
Part B
- Incidence of laboratory abnormalities: Hematology tests [Up to 5 years]
Part B
- Incidence of laboratory abnormalities: Clinical chemistry tests [Up to 5 years]
Part B
- Progression-free survival (PFS) [Up to 5 years]
Part B
- Overall survival (OS) [Up to 5 years]
Part B
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution - 0029 | Little Rock | Arkansas | United States | 72202 |
2 | Local Institution - 0011 | Saint Louis | Missouri | United States | 63110 |
3 | Local Institution - 0001 | Randwick | New South Wales | Australia | 2031 |
4 | Local Institution | South Brisbane | Queensland | Australia | 4101 |
5 | Local Institution - 0002 | Parkville | Victoria | Australia | 3052 |
6 | Local Institution - 0003 | Perth | Western Australia | Australia | 6009 |
7 | Local Institution - 0013 | Villejuif | Val-de-Marne | France | 94805 |
8 | Local Institution - 0014 | Lyon | France | 69373 cedex 03 | |
9 | Local Institution - 0016 | Marseille | France | 13385 | |
10 | Local Institution - 0015 | Paris | France | 75005 | |
11 | Local Institution - 0038 | Hamburg | Germany | 20246 | |
12 | Local Institution - 0039 | Tuebingen | Germany | 72076 | |
13 | Local Institution - 0037 | Wuerzburg | Germany | 97080 | |
14 | Local Institution - 0027 | Milan | Italy | 20133 | |
15 | Local Institution - 0008 | Barcelona | Spain | 08035 | |
16 | Local Institution - 0009 | Madrid | Spain | 28009 | |
17 | Local Institution - 0059 | Sevilla | Spain | 41013 | |
18 | Local Institution - 0028 | València | Spain | 46026 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Nektar Therapeutics
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- CA045-020
- 2020-000854-85