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.
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
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib |
Trametinib | Mekinist | Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib |
Ipilimumab | Yervoy, BMS-734016 | Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib |
Regorafenib | | Part 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
Name | Type | Description | Interventions |
---|
Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib | Experimental | | |
Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib | Experimental | | - Nivolumab
- Trametinib
- Ipilimumab
|
Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib | Experimental | | - Nivolumab
- Trametinib
- Ipilimumab
|
Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib | Experimental | | - Nivolumab
- Trametinib
- Ipilimumab
|
Part 2 Cohort 5 (3L): Regorafenib | Experimental | | |
Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib | Experimental | | - 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