Clinical Trials /

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

NCT03377361

Description:

The purpose of this study is to investigate treatment with Nivolumab in combination with Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon or rectum that has spread.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers

Clinical Trial IDs

  • ORG STUDY ID: CA209-9N9
  • SECONDARY ID: 2017-001830-24
  • NCT ID: NCT03377361

Conditions

  • Colorectal Cancer
  • Colorectal Tumors
  • Colorectal Carcinoma
  • Colorectal Neoplasm

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Previously Treated Metastatic Colorectal Cancer Doublet
TrametinibMekinistPreviously Treated Metastatic Colorectal Cancer Doublet
IpilimumabYervoy, BMS-734016Previously Treated Metastatic Colorectal Cancer Triplet

Purpose

The purpose of this study is to investigate treatment with Nivolumab in combination with Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon or rectum that has spread.

Trial Arms

NameTypeDescriptionInterventions
Previously Treated Metastatic Colorectal Cancer DoubletExperimentalTreatment of mCRC participants
  • Nivolumab
  • Trametinib
Previously Treated Metastatic Colorectal Cancer TripletExperimentalTreatment of mCRC participants
  • Nivolumab
  • Trametinib
  • Ipilimumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Adverse Events (AEs)
Time Frame:Approximately 40 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Disease control rate (DCR)
Time Frame:Approximately 20 months
Safety Issue:
Description:
Measure:Duration of response (DoR)
Time Frame:Approximately 20 months
Safety Issue:
Description:
Measure:Time to response (TTR)
Time Frame:Approximately 20 months
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:Approximately 20 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Approximately 40 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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