Dienstag, 11. Mai 2021
Navigation öffnen
Anzeige:
Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

Rekrutierend

NCT-Nummer:
NCT03369223

Studienbeginn:
Dezember 2017

Letztes Update:
09.04.2021

Wirkstoff:
BMS-986249, Nivolumab, Ipilimumab

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
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 46)

Local Institution
50937 Koeln
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to determine whether BMS-986249 both by itself and in

combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Ein-/Ausschlusskriterien

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

visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,

recurrent, and/or unresectable) with measurable disease and have at least 1 lesion

accessible for biopsy

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Some participants must have received, and then progressed, relapsed, or been

intolerant to, at least 1 standard treatment regimen in the advanced or metastatic

setting according to solid tumor histologies

- Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are

permitted for some participants

- Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation

- Willing and able to comply with all study procedures

Exclusion Criteria:

- Primary CNS malignancies, tumors with CNS metastases as the only site of disease or

active brain metastases will be excluded

- Other active malignancy requiring concurrent intervention

- Prior organ allograft

- Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Incidence of Adverse Events (AEs) (Time Frame - Up to 2.5 years)

2. Incidence of Serious Adverse Events (SAEs) (Time Frame - Up to 2.5 years)

3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria (Time Frame - Up to 2.5 years)

4. Incidence of AEs leading to discontinuation (Time Frame - Up to 2.5 years)

5. Incidence of death (Time Frame - Up to 4 years)

6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests (Time Frame - Up to 2.5 years)

7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests (Time Frame - Up to 2.5 years)

8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests (Time Frame - Up to 2.5 years)

9. Incidence of treatment-related Grade 3-5 AEs (Time Frame - Within 24 weeks)

10. Objective Response Rate as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Time Frame - Up to 2.5 years)

Secondary outcome:

1. Cmax (Maximum observed serum concentration) (Time Frame - Up to 2 years)

2. Tmax (Time of maximum observed concentration) (Time Frame - Up to 2 years)

3. AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) (Time Frame - Up to 2 years)

4. AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) (Time Frame - Up to 2 years)

5. Ctau (Observed concentration at the end of a dosing interval) (Time Frame - Up to 2 years)

6. Ctrough (Trough observed concentrations) (Time Frame - Up to 2 years)

7. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) (Time Frame - Up to 2 years)

8. Terminal serum half-life if data permit (T-HALF) (Time Frame - Up to 2 years)

9. Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] (Time Frame - Up to 2 years)

10. Total body clearance (CLT) (Time Frame - Up to 2 years)

11. Objective Response Rate (ORR) (Time Frame - Up to 4 years)

12. Duration of response (DOR) (Time Frame - Up to 4 years)

13. Progression-Free survival (PFS) (Time Frame - Up to 4 years)

14. Time to response (TTR) (Time Frame - Up to 4 years)

15. Incidence of Adverse Events (AEs) in Part 2 of Study (Time Frame - Up to 2.5 years)

16. Incidence of Serious Adverse Events (SAEs) in Part 2 of Study (Time Frame - Up to 2.5 years)

17. Incidence of AEs leading to discontinuation in Part 2 of study (Time Frame - Up to 2.5 years)

18. Incidence of death in Part 2 of study (Time Frame - Up to 4 years)

19. Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study (Time Frame - Up to 2.5 years)

20. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study (Time Frame - Up to 2.5 years)

21. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study (Time Frame - Up to 2.5 years)

22. Time to Deterioration (TTD) in Part 2 of study (Time Frame - Up to 4 Years)

Studien-Arme

  • Experimental: Part 1A: BMS-986249
  • Experimental: Part 1B: BMS-986249 + nivolumab (nivo)
  • Experimental: Part 2A Arm C: BMS-986249 + nivo
    Previously untreated unresectable stage III-IV melanoma
  • Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
    Previously untreated unresectable stage III-IV melanoma
  • Experimental: Part 2A Arm F: BMS-986249 + nivo
    Previously untreated unresectable stage III-IV melanoma
  • Experimental: Part 2B Cohort 1: BMS-986249 + nivo
    Advanced hepatocellular carcinoma (HCC)
  • Experimental: Part 2B Cohort 2: BMS-986249 + nivo
    Metastatic castration-resistant prostate cancer (CRPC)
  • Experimental: Part 2B Cohort 3: BMS-986249 + nivo
    Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
  • Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
    Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
  • Experimental: Part 2A Arm B: BMS-986249 + nivo
    Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
  • Experimental: Part 2A Arm E: Nivo
    Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm

Geprüfte Regime

  • BMS-986249:
    specified dose on specified day
  • Nivolumab (Opdivo / BMS-936558 / ):
    Specified dose on specified days
  • Ipilimumab (Yervoy / BMS 734016 / ):
    Specified dose on specified days

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
Weltkrebstag: Besonderer Kündigungsschutz bei Schwerbehinderung
Weltkrebstag%3A+Besonderer+K%C3%BCndigungsschutz+bei+Schwerbehinderung+
©DedMityay - stock.adobe.com

Beim Erstantrag auf Schwerbehinderung ist für Krebspatientinnen und -patienten meist allein die Diagnose Krebs ausreichend, um einen Grad der Behinderung (GdB) von 50 zu bekommen. Damit gilt für sie automatisch ein besonderer Kündigungsschutz, in der Regel für 5 Jahre. Und dann? Wie geht es weiter? Unter welchen Voraussetzungen der besondere Kündigungsschutz erhalten werden kann, erläutert der...