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Active, Not Recruiting

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Patients With Previously Treated Cancer of the Colon or Rectum That Has Spread - CA209-9N9

Oppdatert: 1 mars, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 1/Phase 2

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab, Ipilimumab Drug: Trametinib
Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab, Ipilimumab Drug: Trametinib
Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab, Ipilimumab Drug: Trametinib
Experimental: Part 2 Cohort 5 (3L): Regorafenib
Drug: Regorafenib
Experimental: Previously Treated Metastatic Colorectal Cancer Doublet
Biological: Nivolumab Drug: Trametinib
Experimental: Previously Treated Metastatic Colorectal Cancer Triplet
Biological: Nivolumab, Ipilimumab Drug: Trametinib

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have previously treated metastatic colorectal cancer - Must have RAS mutation and microsatellite stability status results as part of medical history - Must agree to provide archival or newly obtained tumor tissue sample prior to the start of treatment in this study - Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 - Ability to swallow pills or capsules - Adequate organ functions - Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up Exclusion Criteria: - BRAF V600 mutant colorectal cancer - Active brain metastases or leptomeningeal metastases - Active, known or suspected autoimmune disease - Histology other than adenocarcinoma - 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 MEK inhibitors - History of allergy to study treatments or any of its components of the study arm that participant is enrolling Other protocol defined inclusion/exclusion criteria could apply

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046