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
Status: | Recruiting |
---|---|
Conditions: | Colorectal Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | January 22, 2018 |
End Date: | November 24, 2022 |
Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
Email: | Clinical.Trials@bms.com |
Phone: | please email: |
A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers
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.
Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon
or rectum that has spread.
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
We found this trial at
18
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 267-319-2602
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-3538
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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500 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-9000
Phone: 415-502-3310
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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