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JOURNAL ONKOLOGIE – STUDIE

CheckMate 8HW A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Rekrutierend

NCT-Nummer:
NCT04008030

Studienbeginn:
Juli 2019

Letztes Update:
03.11.2020

Wirkstoff:
Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan, Bevacizumab, Cetuximab, Nivolumab

Indikation (Clinical Trials):
Colorectal Neoplasms, Microsatellite Instability

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 147)

Local Institution
19104 Philadelphia
United StatesZurückgezogen» Google-Maps
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Frederic Lemay, Site 0015
Phone: +8193461110
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The main purpose of this study is to compare the clinical benefit, as measured by

Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS),

achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in

participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR)

metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab

combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Ein-/Ausschlusskriterien

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

visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective

of prior treatment history with chemotherapy and/or targeted agents not amenable to

surgery (Applicable only during Part 1 enrollment of the study)

- Histologically confirmed recurrent or metastatic CRC with no prior treatment history

with chemotherapy and/or targeted agents for metastatic disease and not amenable to

surgery (Applicable during Part 2 enrollment of the study)

- Known tumor MSI-H or dMMR status per local standard of practice

- Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

- Participants with an active, known or suspected autoimmune disease

- History of interstitial lung disease or pneumonitis

- Known history of positive test for human immunodeficiency virus (HIV) or known

acquired immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

2. PFS by BICR (arm B vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

Secondary outcome:

1. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

2. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

3. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) (Time Frame - Up to 5 years)

4. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) (Time Frame - Up to 5 years)

5. PFS by BICR (arm B vs A, 1L, centrally confirmed) (Time Frame - Up to 5 years)

6. ORR by BICR (arm B vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

7. ORR by BICR (arm B vs A, 1L, centrally confirmed) (Time Frame - Up to 5 years)

8. OS (arm B vs A, 1L, centrally confirmed) (Time Frame - Up to 5 years)

9. PFS by BICR (arm A vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

10. OS (arm B vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

11. ORR by BICR (arm A vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

12. OS (arm A vs C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

13. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) (Time Frame - Up to 5 years)

14. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing) (Time Frame - Up to 5 years)

15. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing) (Time Frame - Up to 5 years)

16. PFS by BICR (arm B vs C, 1L, by each central test) (Time Frame - Up to 5 years)

17. PFS by BICR (arm B vs A, all lines, by each central test) (Time Frame - Up to 5 years)

18. PFS by BICR (crossover cohort, centrally confirmed) (Time Frame - Up to 5 years)

19. ORR by BICR (crossover cohort, centrally confirmed) (Time Frame - Up to 5 years)

Studien-Arme

  • Experimental: Arm A: Nivolumab Monotherapy
    Specified dose on specified days
  • Experimental: Arm B: Nivolumab + Ipilimumab Combination
    Specified dose on specified days
  • Active Comparator: Arm C: Investigator's Choice Chemotherapy
    Specified dose on specified days. Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress

Geprüfte Regime

  • Ipilimumab:
    Specified dose on specified days
  • Oxaliplatin:
    Specified dose on specified days
  • Leucovorin:
    Specified dose on specified days
  • Fluorouracil:
    Specified dose on specified days
  • Irinotecan:
    Specified dose on specified days
  • Bevacizumab:
    Specified dose on specified days
  • Cetuximab:
    Specified dose on specified days
  • Nivolumab:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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