TerminatedPhase 1/2

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

Stopped: Business objectives have changed

United States, Australia, France15 participantsStarted 2021-06-03

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 insufficienc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

Timeframe: From first dose to 42 days after first dose

Number of Participants With Adverse Events (AEs) - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants With Serious Adverse Events (SAEs) - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants With Drug-Related Adverse Events - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants With Adverse Events Leading to Discontinuation - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants Who Died - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Trial details

NCT IDNCT04730349

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-22

Results submitted2022-12-21

View on ClinicalTrials.gov More Ependymoma trials

Plain-language summary

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

Timeframe: From first dose to 42 days after first dose

Number of Participants With Adverse Events (AEs) - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants With Serious Adverse Events (SAEs) - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants With Drug-Related Adverse Events - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants With Adverse Events Leading to Discontinuation - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Number of Participants Who Died - Part A

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)