Trials / Terminated
TerminatedNCT04730349
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ependymoma
- Ewing Sarcoma
- High-grade Glioma
- Leukemia and Lymphoma
- Medulloblastoma
- Miscellaneous Brain Tumors
- Miscellaneous Solid Tumors
- Neuroblastoma
- Relapsed, Refractory Malignant Neoplasms
- Rhabdomyosarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| BIOLOGICAL | NKTR-214 | Specified dose on specified days |
Timeline
- Start date
- 2021-06-03
- Primary completion
- 2022-06-22
- Completion
- 2022-06-22
- First posted
- 2021-01-29
- Last updated
- 2023-03-24
- Results posted
- 2023-03-24
Locations
18 sites across 6 countries: United States, Australia, France, Germany, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04730349. Inclusion in this directory is not an endorsement.