Description:
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.
Title
- Brief Title: A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CA045-020
- SECONDARY ID:
2020-000854-85
- NCT ID:
NCT04730349
Conditions
- Ependymoma
- Ewing Sarcoma
- High-grade Glioma
- Leukemia and Lymphoma
- Medulloblastoma
- Miscellaneous Brain Tumors
- Miscellaneous Solid Tumors
- Neuroblastoma
- Relapsed, Refractory Malignant Neoplasms
- Rhabdomyosarcoma
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | BMS-936558-01 | A1F Dosing schema |
NKTR-214 | Bempegaldesleukin (BEMPEG) | A1F Dosing schema |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
A1W Dosing schema | Experimental | | |
A1F Dosing schema | Experimental | | |
A2W Dosing schema | Experimental | | |
A2F Dosing schema | Experimental | | |
Part B: Cohort B1 Neuroblastoma | Experimental | | |
Part B: Cohort B2 Ewing sarcoma | Experimental | | |
Part B: Cohort B3 Rhabdomyosarcoma | Experimental | | |
Part B: Cohort B4 Miscellaneous solid tumors | Experimental | | |
Part B: Cohort B5 NHL/leukemia | Experimental | | |
Part B: Cohort B6 High-grade glioma | Experimental | | |
Part B: Cohort B7 Medulloblastoma and Embryonal Tumors | Experimental | | |
Part B: Cohort B8 Ependymoma | Experimental | | |
Part B: Cohort B9 Miscellaneous brain tumors | Experimental | | |
Eligibility 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
Maximum Eligible Age: | 30 Years |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose-limiting toxicities |
Time Frame: | Up to 2 years and 100 days |
Safety Issue: | |
Description: | Part A |
Secondary Outcome Measures
Measure: | Incidence of AEs |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Incidence of SAEs |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Incidence of drug-related AEs |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Incidence of AEs leading to discontinuation |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Incidence of death |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Incidence of laboratory abnormalities: Hematology tests |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Incidence of laboratory abnormalities: Clinical chemistry tests |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Measure: | Overall survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Part B |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL)
- BEMPEG
- Bempegaldesleukin
- CD122-Biased Agonist
- CD122-Biased Cytokine
- Check point inhibitor
- Ependymoma
- Ewing sarcoma
- High-grade glioma (HGG)/diffuse intrinsic pontine glioma (DIPG)
- Immunotherapy
- IL-2
- IL-2 Receptor Agonist
- Leukemia and lymphoma
- Medulloblastoma
- Melanoma
- Miscellaneous brain tumors
- Miscellaneous solid tumors
- Neuroblastoma
- Nivolumab
- NKTR-214
- NIVO
- Non-rhabdomyosarcoma soft-tissue sarcomas
- Opdivo®
- Pediatric cancer
- Pediatric malignancy
- Rhabdomyosarcoma
Last Updated
January 29, 2021