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JOURNAL ONKOLOGIE – STUDIE
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

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NCT-Nummer:
NCT04730349

Studienbeginn:
April 2021

Letztes Update:
29.01.2021

Wirkstoff:
Nivolumab, NKTR-214

Indikation (Clinical Trials):
Lymphoma, Neoplasms, Leukemia, Sarcoma, Glioma, Brain Neoplasms, Neuroblastoma, Rhabdomyosarcoma, Ependymoma, Sarcoma, Ewing, Medulloblastoma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
Nektar Therapeutics

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Kontakt:
Phone: please email:
E-Mail: Clinical.Trials@bms.com
» Kontaktdaten anzeigen
First line of the email MUST contain NCT # and Site #.

Studienlocations
(3 von 14)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of dose-limiting toxicities (Time Frame - Up to 2 years and 100 days):
Part A

2. Incidence of adverse events (AEs) (Time Frame - Up to 2 years and 100 days):
Part A

3. Incidence of serious AEs (SAEs) (Time Frame - Up to 2 years and 100 days):
Part A

4. Incidence of drug-related AEs (Time Frame - Up to 2 years and 100 days):
Part A

5. Incidence of AEs leading to discontinuation (Time Frame - Up to 2 years and 100 days):
Part A

6. Incidence of death (Time Frame - Up to 2 years and 100 days):
Part A

7. Pharmacokinetic (PK) parameters: Peak concentration (Time Frame - Up to 2 years):
Part A

8. Pharmacokinetic (PK) parameters: Trough concentration (Time Frame - Up to 2 years):
Part A

9. Pharmacokinetic (PK) parameters: Time-averaged concentration (Time Frame - Up to 2 years):
Part A

10. Pharmacokinetic (PK) parameters: Clearance (CL) (Time Frame - Up to 2 years):
Part A

11. Pharmacokinetic (PK) parameters: Volume of distribution (Vd) (Time Frame - Up to 2 years):
Part A

12. Investigator-assessed objective response rate (ORR) (Time Frame - Up to 5 years):
Part B

Secondary outcome:

1. Incidence of AEs (Time Frame - Up to 5 years):
Part B

2. Incidence of SAEs (Time Frame - Up to 5 years):
Part B

3. Incidence of drug-related AEs (Time Frame - Up to 5 years):
Part B

4. Incidence of AEs leading to discontinuation (Time Frame - Up to 5 years):
Part B

5. Incidence of death (Time Frame - Up to 5 years):
Part B

6. Incidence of laboratory abnormalities: Hematology tests (Time Frame - Up to 5 years):
Part B

7. Incidence of laboratory abnormalities: Clinical chemistry tests (Time Frame - Up to 5 years):
Part B

8. Progression-free survival (PFS) (Time Frame - Up to 5 years):
Part B

9. Overall survival (OS) (Time Frame - Up to 5 years):
Part B

Studien-Arme

  • Experimental: 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

Geprüfte Regime

  • Nivolumab (BMS-936558-01):
    Specified dose on specified days
  • NKTR-214 (Bempegaldesleukin (BEMPEG)):
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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