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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 (CheckMate 9N9)

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ClinicalTrials.gov Identifier: NCT03377361
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Tumors Colorectal Carcinoma Colorectal Neoplasm Biological: Nivolumab Drug: Trametinib Biological: Ipilimumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : September 21, 2021
Estimated Study Completion Date : November 24, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Previously Treated Metastatic Colorectal Cancer Doublet
Treatment of mCRC participants
Biological: Nivolumab
specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Trametinib
specified dose on specified days
Other Name: Mekinist

Experimental: Previously Treated Metastatic Colorectal Cancer Triplet
Treatment of mCRC participants
Biological: Nivolumab
specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Trametinib
specified dose on specified days
Other Name: Mekinist

Biological: Ipilimumab
specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016




Primary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: Approximately 40 months ]
  2. Number of Serious Adverse Events (SAEs) [ Time Frame: Approximately 40 months ]
  3. Objective response rate (ORR) [ Time Frame: Approximately 20 months ]

Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: Approximately 20 months ]
  2. Duration of response (DoR) [ Time Frame: Approximately 20 months ]
  3. Time to response (TTR) [ Time Frame: Approximately 20 months ]
  4. Progression free survival (PFS) [ Time Frame: Approximately 20 months ]
  5. Overall survival (OS) [ Time Frame: Approximately 40 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377361


Locations
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United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Usc
Los Angeles, California, United States, 90033
University of California San Francisco (UCSF)
San Francisco, California, United States, 94158
United States, North Carolina
Local Institution
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53705
Italy
Local Institution
Milano, Italy, 20133
Local Institution
Modena, Italy, 41124
Local Institution
Padova, Italy, Padova
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Rostov-on-don, Russian Federation, 344037
Sponsors and Collaborators
Bristol-Myers Squibb
Novartis
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03377361     History of Changes
Other Study ID Numbers: CA209-9N9
2017-001830-24 ( EudraCT Number )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nivolumab
Ipilimumab
Trametinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action