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JOURNAL ONKOLOGIE – STUDIE

CheckMate901 Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Patients With Untreated Inoperable or Metastatic Urothelial Cancer

Rekrutierend

NCT-Nummer:
NCT03036098

Studienbeginn:
März 2017

Letztes Update:
27.08.2019

Wirkstoff:
Gemcitabine, Cisplatin, Carboplatin, Nivolumab, Ipilimumab

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Bristol-Myers Squibb

Collaborator:
Ono Pharmaceutical Co. Ltd

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 191)

Local Institution
81675 Muenchen
(Bayern)
GermanyZurückgezogen» Google-Maps
Local Institution
35223 Birmingham
United StatesZurückgezogen» Google-Maps
Local Institution
35233 Birmingham
United StatesZurückgezogen» Google-Maps
Local Institution
72205 Little Rock
United StatesZurückgezogen» Google-Maps
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
31792 Thomasville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Josh Simmons, Site 0033
Phone: 229-584-5417
» Ansprechpartner anzeigen
Local Institution
84112 Salt Lake City
United StatesZurückgezogen» Google-Maps
London Regional Cancer Program, London Health Sciences Centre
N6A 4L6 London
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Michel Pavic, Site 0052
Phone: 819346111012811
» Ansprechpartner anzeigen
Local Institution
036-8563 Hirosaki-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
260-8717 Chiba-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
7910280 Matsuyama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
8128582 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
0608543 Sapporo-city
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
3058576 Tsukuba-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
7610793 Kita-Gun
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
9518520 Niigata-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
5418567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
589-8511 Osakasayama
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
5698686 Takatsuki-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
431-3192 Hamamatsu-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
1168567 Arakawa-ku,tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
1138519 Bunkyo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
1138602 Bunkyo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
1608582 Shinjuku-Ku
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
6418510 Wakayama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
755-8505 Ube City
JapanAktiv, nicht rekrutierend» Google-Maps
Local Institution
10408 Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Local Institution
13620 Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Local Institution
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Local Institution
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Local Institution
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Local Institution
11217 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.

Ein-/Ausschlusskriterien

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

Inclusion Criteria:

- Metastatic or inoperable urothelial cancer

- Must have at least 1 lesion with measurable disease

- Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work

- No prior systemic chemotherapy treatment in the metastatic setting

Exclusion Criteria:

- Patients with disease that is suitable for local therapy administered with

curative intent

- Patients with active brain metastases or leptomeningeal metastases

- Patients with active, known or suspected autoimmune disease

- Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could apply

Studien-Rationale

Primary outcome:

1. Overall survival (OS) in cisplatin-ineligible randomized participants (Time Frame - Up to 55 months):
Measured by time Only applies to primary study

2. OS in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) (Time Frame - Up to 52 months):
Only applies to primary study

3. PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic Urothelial Carcinoma( UC) (Time Frame - Up to 55 months):
Progression Free Survival (PFS) Measured by time Only applies to sub-study

Secondary outcome:

1. Overall survival (OS) in all randomized participants (Time Frame - Up to 55 months):
Measured by time Applies to primary study

2. PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (≥1%) randomized participants and in all randomized participants (Time Frame - Up to 55 months):
Measured by time Applies to primary study

3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score in all randomized participants (Time Frame - Up to 55 months):
Measured by EORTC QLQ-C30 Applies to primary study

4. OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC. (Time Frame - Up to 55 months):
Measured by time Applies to sub-study

5. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score (Time Frame - Up to 55 months):
Applies to sub-study

6. PFS in PD-L1 positive by BICR (using RECIST 1.1) (Time Frame - Up to 55 months):
Applies to sub-study

7. OS by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) (Time Frame - Up to 55 months):
Applies to sub-study

Studien-Arme

  • Experimental: Arm A: Investigational immunotherapy
    Specified dose of nivolumab and ipilimumab on specified days followed by nivolumab only on specified days
  • Active Comparator: Arm B: Standard of care chemotherapy
    Specified dose of gemcitabine / cisplatin or gemcitabine / carboplatin on specified days
  • Experimental: Arm C: Investigational immunotherapy
    Specified dose of nivolumab plus gemcitabine-cisplatin followed by nivolumab only on specified days
  • Active Comparator: Arm D: Standard of care chemotherapy
    Specified dose of gemcitabine-cisplatin only on specified days

Geprüfte Regime

  • nivolumab (BMS-936558 / Opdivo / ):
    Specified Dose on Specified Days
  • ipilimumab (BMS-734016 / Yervoy / ):
    Specified Dose on Specified Days
  • gemcitabine:
    Specified Dose on Specified Days
  • cisplatin:
    Specified Dose on Specified Days
  • carboplatin:
    Specified Dose on Specified Days

Quelle: ClinicalTrials.gov


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