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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 (CheckMate 9N9)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Colorectal Carcinoma
Colorectal Neoplasm
Colorectal Tumors
Colorectal Cancer

Treatments

Drug: Regorafenib
Drug: Trametinib
Biological: Nivolumab
Biological: Ipilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03377361
2017-001830-24 (EudraCT Number)
CA209-9N9

Details and patient eligibility

About

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.

Enrollment

232 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

232 participants in 6 patient groups

Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
Experimental group
Treatment:
Biological: Nivolumab
Drug: Trametinib
Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
Experimental group
Treatment:
Biological: Ipilimumab
Biological: Nivolumab
Drug: Trametinib
Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Experimental group
Treatment:
Biological: Ipilimumab
Biological: Nivolumab
Drug: Trametinib
Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Experimental group
Treatment:
Biological: Ipilimumab
Biological: Nivolumab
Drug: Trametinib
Part 2 Cohort 5 (3L): Regorafenib
Experimental group
Treatment:
Drug: Regorafenib
Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
Experimental group
Treatment:
Biological: Ipilimumab
Biological: Nivolumab
Drug: Trametinib

Trial contacts and locations

47

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Data sourced from clinicaltrials.gov

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