Nivolumab + Trametinib (+/- Ipilimumab) for Colorectal Cancer

(CheckMate 9N9 Trial)

Recruiting at99 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of drugs to treat patients with advanced colon or rectal cancer who have already tried other treatments. The drugs help the immune system fight cancer and block proteins that help cancer grow. One of the drugs being tested has shown promise in treating advanced colorectal cancer.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with Stage IV colorectal cancer that has spread and was previously treated. They must have measurable disease, be in good physical condition (ECOG 0-1), and not have certain genetic mutations (BRAF V600). People can't join if they've had brain metastases, need systemic steroids or immunosuppressants, are allergic to the drugs being tested, or have used checkpoint inhibitors/MEK inhibitors before.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer's microsatellite status was checked using standard methods.

My colorectal cancer is confirmed to be in stage IV and has been previously treated.

Exclusion Criteria

I have had interstitial lung disease or pneumonitis.

I have an autoimmune disease.

My colorectal cancer has a BRAF V600 mutation.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Trametinib (MAPK Inhibitor)

Trial Overview The study tests nivolumab combined with trametinib, with some participants also receiving ipilimumab. It aims to see how well these drugs work together in treating colorectal cancer that's spread after previous treatment. Participants will be randomly assigned to different drug combinations.

Participant Groups

Group I: Part 2 Cohort 5 (3L): Regorafenib Experimental Treatment 1 Intervention

Group II: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib Experimental Treatment 3 Interventions

Group III: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib Experimental Treatment 3 Interventions

Group IV: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib Experimental Treatment 3 Interventions

Group V: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib Experimental Treatment 3 Interventions

Group VI: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib Experimental Treatment 2 Interventions

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania