Clinical Trials /

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

NCT03377361

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
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 Participants 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-936558Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
TrametinibMekinistPart 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
IpilimumabYervoy, BMS-734016Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
RegorafenibPart 2 Cohort 5 (3L): Regorafenib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinibExperimental
  • Nivolumab
  • Trametinib
Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinibExperimental
  • Nivolumab
  • Trametinib
  • Ipilimumab
Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinibExperimental
  • Nivolumab
  • Trametinib
  • Ipilimumab
Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinibExperimental
  • Nivolumab
  • Trametinib
  • Ipilimumab
Part 2 Cohort 5 (3L): RegorafenibExperimental
  • Regorafenib
Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinibExperimental
  • Nivolumab
  • Trametinib
  • Ipilimumab

Eligibility Criteria

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

Primary Outcome Measures

Measure:Incidence of dose limiting toxicity (DLTs)
Time Frame:Up to 23 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR) (Part 1A and Part 1)
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Time to response (TTR)
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Progression-free survival (PFS) by investigator per response evaluation criteria in solid tumors (RECIST) v1.1
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Best overall response (BOR)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Approximately 40 months
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Approximately 100 months
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Approximately 100 months
Safety Issue:
Description:
Measure:Incidence of Deaths
Time Frame:Up to 100 months
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Up to 77 months
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame:Up to 77 months
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame:Up to 77 months
Safety Issue:
Description:

Details

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

Last Updated

February 9, 2021