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Fachinformation
JOURNAL ONKOLOGIE – STUDIE
CheckMate 9N9

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

Rekrutierend

NCT-Nummer:
NCT03377361

Studienbeginn:
Februar 2018

Letztes Update:
09.02.2021

Wirkstoff:
Trametinib, Nivolumab, Ipilimumab, Regorafenib

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
Novartis

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 83)

Local Institution
50937 Cologne
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Local Institution
20251 Hamburg
(Hamburg)
GermanyZurückgezogen» Google-Maps
Local Institution
30625 Hannover
(Niedersachsen)
GermanyZurückgezogen» Google-Maps
Local Institution
74078 Heilbronn
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Local Institution
68163 Mannheim
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Local Institution
89081 Ulm
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Local Institution
97080 Wuerzburg
(Bayern)
GermanyZurückgezogen» Google-Maps
University Of Alabama At Birmingham
35294 Birmingham
United StatesAktiv, nicht rekrutierend» Google-Maps
Mayo Clinic Hospital
85054 Phoenix
United StatesZurückgezogen» Google-Maps
USC Norris Comprehensive Cancer Center
90033 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
Ucsf Cancer Center
94158 San Francisco
United StatesAktiv, nicht rekrutierend» Google-Maps
Poudre Valley Health System
80598 Fort Collins
United StatesZurückgezogen» Google-Maps
Local Institution
46202 Indianapolis
United StatesZurückgezogen» Google-Maps
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
21287 Baltimore
United StatesZurückgezogen» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesZurückgezogen» Google-Maps
Beth Israel Desc. Med Ctr
02215 Boston
United StatesZurückgezogen» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesZurückgezogen» Google-Maps
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone
10016 New York
United StatesZurückgezogen» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesZurückgezogen» Google-Maps
University Of Pennsylvania
19104 Philadelphia
United StatesAbgeschlossen» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesZurückgezogen» Google-Maps
University Of Wisconsin
53705 Madison
United StatesAbgeschlossen» Google-Maps
Local Institution
1264 Capital Federal
ArgentinaZurückgezogen» Google-Maps
Local Institution
1431 Ciudad Autonoma Beunos Aires
ArgentinaZurückgezogen» Google-Maps
Local Institution
115478 Moscow
Russian FederationZurückgezogen» Google-Maps
Local Institution
AB25 2ZN Aberdeen
United KingdomZurückgezogen» Google-Maps
Local Institution
BS2 8ED Bristol
United KingdomZurückgezogen» Google-Maps
Local Institution
SW17 ORE London
United KingdomZurückgezogen» Google-Maps
Local Institution
CV2 2DX Coventry
United KingdomZurückgezogen» Google-Maps
Local Institution
M20 4BX Manchester
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to investigate treatment with nivolumab in combination with

trametinib with or without ipilimumab in participants with previously treated cancer of the

colon or rectum that has spread.

Ein-/Ausschlusskriterien

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

visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologically or cytologically confirmed previously treated metastatic colorectal

cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on

Cancer (version 4.0) at study entry

- Microsatellite status should be performed per local standard of practice,

immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required

for determining microsatellite stable (MSS) status

- Must have measurable disease per RECIST 1.1. Participants with lesions in a previously

irradiated field as the sole site of measurable disease will be permitted to enroll

provided the lesion(s) have demonstrated clear progression and can be measured

accurately

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and

on cycle 1 day 1 (C1D1)

Exclusion Criteria:

- BRAF V600 mutant colorectal cancer

- Active brain metastases or leptomeningeal metastases

- Active, known or suspected autoimmune disease

- Participants with a condition requiring systemic treatment with either corticosteroids

(> 10 mg daily prednisone equivalents) or other immunosuppressive medications within

14 days of study treatment administration

- History of interstitial lung disease or pneumonitis

- Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase

enzymes (MEK) inhibitors

- History of allergy or hypersensitivity to study drug components

Other protocol defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Incidence of dose limiting toxicity (DLTs) (Time Frame - Up to 23 months)

2. Incidence of Adverse Events (AEs) (Time Frame - Approximately 100 months)

3. Incidence of Serious Adverse Events (SAEs) (Time Frame - Approximately 100 months)

4. Incidence of Deaths (Time Frame - Up to 100 months)

5. Incidence of clinically significant changes in clinical laboratory results: Hematology tests (Time Frame - Up to 77 months)

6. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests (Time Frame - Up to 77 months)

7. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests (Time Frame - Up to 77 months)

8. Objective response rate (ORR) by investigator (Part 1B and Part 2) (Time Frame - Approximately 24 months)

Secondary outcome:

1. Objective response rate (ORR) (Part 1A and Part 1) (Time Frame - Approximately 24 months)

2. Disease control rate (DCR) (Time Frame - Approximately 24 months)

3. Duration of response (DOR) (Time Frame - Approximately 24 months)

4. Time to response (TTR) (Time Frame - Approximately 24 months)

5. Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 (Time Frame - Approximately 24 months)

6. Best overall response (BOR) (Time Frame - Up to 24 months)

7. Overall survival (OS) (Time Frame - Approximately 40 months)

8. Incidence of Adverse Events (AEs) (Time Frame - Approximately 100 months)

9. Incidence of Serious Adverse Events (SAEs) (Time Frame - Approximately 100 months)

10. Incidence of Deaths (Time Frame - Up to 100 months)

11. Incidence of clinically significant changes in clinical laboratory results: Hematology tests (Time Frame - Up to 77 months)

12. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests (Time Frame - Up to 77 months)

13. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests (Time Frame - Up to 77 months)

Studien-Arme

  • Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
  • Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
  • Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
  • Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
  • Experimental: Part 2 Cohort 5 (3L): Regorafenib
  • Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib

Geprüfte Regime

  • Nivolumab (Opdivo / BMS-936558 / ):
    Specified dose on specified days
  • Trametinib (Mekinist):
    Specified dose on specified days
  • Ipilimumab (Yervoy / BMS-734016 / ):
    Specified dose on specified days
  • Regorafenib:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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