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JOURNAL ONKOLOGIE – STUDIE

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Rekrutierend

NCT-Nummer:
NCT03635983

Studienbeginn:
September 2018

Letztes Update:
17.11.2020

Wirkstoff:
NKTR-214, Nivolumab

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

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 176)

Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jessica Hassel, Site 0020
Phone: +4962215636871
» Ansprechpartner anzeigen
Universitatsklinikum AoR Klinik fur Dermatologie, Venerologie und Allergologie
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jan Simon, Site 0022
Phone: +493419718371
» Ansprechpartner anzeigen
Local Institution
90095 Los Angeles
United StatesZurückgezogen» Google-Maps
Local Institution
55407-3799 Minneapolis
United StatesZurückgezogen» Google-Maps
Local Institution
4120 Greenslopes
AustraliaAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of the study is to test the effectiveness (how well the drug works), safety, and

tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus

nivolumab given alone in participants with previously untreated melanoma skin cancer that is

either unable to be surgically removed or has spread

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

visit www.BMSStudyConnect.com

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or

older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)

- Histologically confirmed stage III (unresectable) or stage IV melanoma

- Treatment-naive participants (ie, no prior systemic anticancer therapy for

unresectable or metastatic melanoma) with the exception of prior adjuvant and/or

neoadjuvant treatment for melanoma with approved agents

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Uveal melanoma

- Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Studien-Rationale

Primary outcome:

1. Overall response rate (ORR) by Blinded Independent Central Review (BICR) (Time Frame - Approximately 16 months)

2. Progression-free survival (PFS) by BICR (Time Frame - Approximately 22 months)

3. Overall survival (OS) (Time Frame - Up to 59 months)

Secondary outcome:

1. Clinical benefit rate (CBR) (Time Frame - Approximately 16 months)

2. Duration of response (DoR) (Time Frame - Approximately 16 months)

3. Time to response (TTR) (Time Frame - Approximately 16 months)

4. ORR by investigator and in biomarker population (Time Frame - Approximately 16 months)

5. PFS by investigator and in biomarker population (Time Frame - Approximately 22 months)

6. OS in biomarker population (Time Frame - Up to 59 months)

7. Incidence of participants with non-serious Adverse Events (AEs) (Time Frame - Up to 5 years)

8. Incidence of participants with Serious Adverse Events (SAEs) (Time Frame - Up to 5 years)

9. Incidence of treatment-related AEs (Time Frame - Up to 5 years)

10. Incidence of treatment-related SAEs (Time Frame - Up to 5 years)

11. Incidence of laboratory abnormalities in blood (Time Frame - Up to 5 years)

12. Incidence of laboratory abnormalities in blood serum (Time Frame - Up to 5 years)

13. Incidence of laboratory abnormalities in urine (Time Frame - Up to 5 years)

Studien-Arme

  • Experimental: Combination
    NKTR-214 + Nivolumab
  • Experimental: Monotherapy
    Nivolumab

Geprüfte Regime

  • NKTR-214 (Bempegaldesleukin / BMS-986321 / ):
    Specified dose on specified days
  • Nivolumab (Opdivo / BMS-936558 / ):
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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