Mittwoch, 14. April 2021
Navigation öffnen
Anzeige:
Vectibix
JOURNAL ONKOLOGIE – STUDIE

An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

Rekrutierend

NCT-Nummer:
NCT02658890

Studienbeginn:
Februar 2016

Letztes Update:
10.08.2020

Wirkstoff:
BMS-986205, Nivolumab, Ipilimumab

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

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, please email:
Kontakt:
E-Mail: Clinical.Trials@bms.com
» Kontaktdaten anzeigen
First line of the email MUST contain NCT# and Site #.

Studienlocations
(3 von 52)

Local Institution
45147 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Local Institution
74078 Heilbronn
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
University of Arizona Cancer Center
85724-5024 Tucson
United StatesAktiv, nicht rekrutierend» Google-Maps
UCSD Moores Cancer Center
92093-0698 La Jolla
United StatesAktiv, nicht rekrutierend» Google-Maps
Local Institution
32224 Jacksonville
United StatesZurückgezogen» Google-Maps
H. Lee Moffitt Cancer Center
33612-9497 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Emory Winship Cancer Institute
30322 Atlanta
United StatesAktiv, nicht rekrutierend» Google-Maps
Northside Hospital, Inc
30342 Atlanta
United StatesAktiv, nicht rekrutierend» Google-Maps
University Of Chicago
60637 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
21093 Lutherville
United StatesAktiv, nicht rekrutierend» Google-Maps
Barbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesAktiv, nicht rekrutierend» Google-Maps
Washington University
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps
Hackensack University Medical Center
07601 Hackensack
United StatesAbgeschlossen» Google-Maps
New York University
10016 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
Cleveland Clinic
44195 Cleveland
United StatesAktiv, nicht rekrutierend» Google-Maps
Fox Chase Cancer Center
19111-2412 Philadelphia
United StatesAbgebrochen» Google-Maps
UPMC Hillman Cancer Center
15232 Pittsburgh
United StatesAktiv, nicht rekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaAktiv, nicht rekrutierend» Google-Maps
Local Institution
V5Z 4E6 Vancouver
CanadaAktiv, nicht rekrutierend» Google-Maps
Local Institution
M5G 1Z5 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Jewish General Hospital
H3T 1E2 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Local Institution
00180 Helsinki
FinlandAktiv, nicht rekrutierend» Google-Maps
Hopital Claude Huriez
59037 Lille CEDEX
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution
69373 Lyon Cedex 08
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution
13385 Marseille Cedex 5
FranceAktiv, nicht rekrutierend» Google-Maps
Hotel Dieu - Chu De Nantes
44093 Nantes Cedex 01
FranceAktiv, nicht rekrutierend» Google-Maps
Local Institution
31100 Toulouse
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Gustave Roussy
94800 Villejuif
FranceAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen

- During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type

- Subjects must have measurable disease

- Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.

- At least 4 weeks since any previous treatment for cancer

- Must be able to swallow pills or capsules

- Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

- Active or chronic autoimmune diseases

- Uncontrolled or significant cardiovascular disease

- History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)

- Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)

- Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease

- Active infection

Other protocol defined inclusion/exclusion criteria could apply

Studien-Rationale

Primary outcome:

1. Safety and tolerability of BMS-986205 as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. (Time Frame - 100 days after the last dose of study therapy):
measured by incidence

2. Safety of BMS-986205 plus nivolumab as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. (Time Frame - 100 days after the last dose of study therapy):
measured by incidence

3. Safety of BMS-986205 plus both nivolumab and ipilimumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. (Time Frame - 100 days after the last dose of study therapy):
measured by incidence

4. Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the best overall response (BOR) (Time Frame - Approximately 3 years):
measured by CT scan

5. Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the duration of response (DOR) (Time Frame - Approximately 3 years):
measured by CT scan

6. Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by progression-free survival rates (PFSRs) (Time Frame - Approximately 3 years):
measured by CT scan

7. Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the best overall response (BOR) (Time Frame - Approximately 3 years):
measured by CT scan

8. Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the duration of response (DOR) (Time Frame - Approximately 3 years):
measured by CT scan

9. Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by progression-free survival rates (PFSRs) (Time Frame - Approximately 3 years):
measured by CT scan

Secondary outcome:

1. Maximum observed plasma concentration (Cmax) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

2. Time of maximum observed plasma concentration (Tmax) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

3. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

4. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

5. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

6. Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

7. Observed plasma concentration at 24 hours (C24) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

8. Apparent terminal phase half-life (T-HALF) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

9. Apparent total body clearance (CLT/F) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

10. Apparent renal clearance (CLR/F) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

11. Volume of distribution of terminal phase (Vz/F) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

12. Apparent volume of distribution at steady state (Vss/F) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

13. Accumulation index (AI) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

14. Percent urinary recovery (%UR) of BMS-986205 (Time Frame - Approximately 3 years):
measured by urine concentration

15. Percent urinary recovery over 24 hours(%UR24) of BMS-986205 (Time Frame - Approximately 3 years):
measured by urine concentration

16. Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

17. Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

18. Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

19. Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205 (Time Frame - Approximately 3 years):
measured by plasma concentration

20. Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205 (Time Frame - Approximately 3 years):
measured by immunoassay and liquid chromatography- mass spectrometry

21. Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205 (Time Frame - Approximately 3 years):
measured by immunoassay and liquid chromatography- mass spectrometry

Studien-Arme

  • Experimental: Combination Therapy (Dose Escalation)
    BMS 986205 + Nivolumab specified dose at specified intervals.
  • Experimental: Combination Therapy (Dose Expansion)
    BMS 986205 + Nivolumab specified dose at specified intervals.
  • Experimental: Combination Therapy 2 (Dose Expansion)
    BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals

Geprüfte Regime

  • BMS-986205
  • Nivolumab (BMS-936558 / ANTI-PD1 / )
  • Ipilimumab (BMS-734016 / ANTI-CTLA-4 / )

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
Junge Krebspatienten: Ausbildung und Familie, aber auch Angst und Schmerzen
Junge+Krebspatienten%3A+Ausbildung+und+Familie%2C+aber+auch+Angst+und+Schmerzen
© pathdoc / Fotolia.com

„Ich hatte große Träume für mein Leben, jetzt denke ich oft viel, viel kurzfristiger“, sagt die 25-jährige Studentin Mia*, die vor anderthalb Jahren an Krebs erkrankte. Nach der Diagnose musste sie ihr Studium unterbrechen, ihre Familienplanung in Frage stellen und auch mit ihrem Freundeskreis einen neuen Umgang finden. Sie ist eine von rund 15.000 jungen Menschen, die jährlich im Alter von 18 bis 39 Jahren...

Prävention: „Körperliche Aktivität so wichtig wie ein Krebsmedikament“
Pr%C3%A4vention%3A+%E2%80%9EK%C3%B6rperliche+Aktivit%C3%A4t+so+wichtig+wie+ein+Krebsmedikament%E2%80%9C
© Heidi Mehl / Fotolia.com

Nach Schätzungen beruhen etwa 70 Prozent aller behandelten Erkrankungen in den Industrienationen auf Lebensstilfaktoren, wie Übergewicht, das aufgrund von falscher Ernährung und mangelnder Bewegung entstanden ist. Ein gesunder Lebensstil sei ein wesentlicher Präventionsfaktor und müsse dringend gesundheitspolitisch verankert werden, fordert ein Experte im Vorfeld der MEDICA EDUCATION CONFERENCE 2016. Es gelte nicht...

Mit neuer Website „psyche-hilft-koerper.de“ finden Krebspatienten schnell und einfach psychoonkologische Hilfe
Mit+neuer+Website+%E2%80%9Epsyche-hilft-koerper.de%E2%80%9C+finden+Krebspatienten+schnell+und+einfach+psychoonkologische+Hilfe
© www.psyche-hilft-koerper.de

Die Website „psyche-hilft-koerper.de“ ermöglicht es, über eine Postleitzahl-Suche Psychoonkologen in der Region, in der man lebt, zu finden. Eine psychoonkologische Betreuung unterstützt Patienten u. a. dabei, ihre Krebserkrankung zu verarbeiten, das seelische Befinden zu verbessern sowie körperliche Ressourcen zu stärken (1). Novartis Oncology hat sich nicht nur der Entwicklung innovativer Arzneimittel...