Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
NCT ID: NCT04126733
Last Updated: 2023-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2019-10-14
2022-03-28
Brief Summary
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Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regorafenib + Nivolumab
Regorafenib (Stivarga, BAY73-4506)
Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)
Nivolumab (Opdivo)
Administered on day 1 of every treatment cycle.
Interventions
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Regorafenib (Stivarga, BAY73-4506)
Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)
Nivolumab (Opdivo)
Administered on day 1 of every treatment cycle.
Eligibility Criteria
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Inclusion Criteria
* Participant must have progressed or be intolerant to prior systemic chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy. Exceptions may apply
* Participants must have adequate organ and marrow function defined by protocol-specified laboratory tests
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1
* Provision of recently obtained tumor tissue as per protocol specified requirement
* Anticipated life expectancy greater than 3 months
* Be able to swallow and absorb oral tablets
Exclusion Criteria
* Prior therapy with regorafenib, anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer
* Presence of active central nervous system (CNS) metastases; participants with stable CNS disease or previously treated lesions are eligible for study entry
* Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 mmHg despite optimal medical management
* Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen
* Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication
* Participants with an active, known or suspected autoimmune disease
* History of interstitial lung disease or pneumonitis
* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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City of Hope National Medical Center
Duarte, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists
Papillion, Nebraska, United States
New York Oncology Hematology. P.C.
Albany, New York, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Texas Oncology-Arlington North
Arlington, Texas, United States
Baylor Charles A. Sammons Cancer Center at Dallas
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology-Sherman
Sherman, Texas, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, United States
Countries
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References
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Fakih M, Raghav KPS, Chang DZ, Larson T, Cohn AL, Huyck TK, Cosgrove D, Fiorillo JA, Tam R, D'Adamo D, Sharma N, Brennan BJ, Wang YA, Coppieters S, Zebger-Gong H, Weispfenning A, Seidel H, Ploeger BA, Mueller U, Oliveira CSV, Paulson AS. Regorafenib plus nivolumab in patients with mismatch repair-proficient/microsatellite stable metastatic colorectal cancer: a single-arm, open-label, multicentre phase 2 study. EClinicalMedicine. 2023 Apr 6;58:101917. doi: 10.1016/j.eclinm.2023.101917. eCollection 2023 Apr.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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20975
Identifier Type: -
Identifier Source: org_study_id
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