Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03712943|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Colorectal Cancer Colon Cancer||Drug: Regorafenib Drug: Nivolumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Regorafenib and Nivolumab|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Regorafenib and Nivolumab in Mismatch Repair (MMR) Proficient Advanced Refractory Colorectal Cancer|
|Actual Study Start Date :||October 12, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2022|
Experimental: Regorafenib and Nivolumab Combination
Dose Escalation: To find the dose of regorafenib that can be safely given with nivolumab in patients with advanced, refractory colorectal cancers.
Dose Expansion: To find the effect on tumor of the combination of regorafenib and nivolumab.
Regorafenib orally 80 mg daily for 21 days (3 weeks on, 1 week off).
Other Name: Stivarga
Nivolumab 240 mg administered intravenously every 2 weeks.
Other Name: OPDIVO
- Maximum Tolerated Dose [ Time Frame: Up to 12 months ]To determine the maximum tolerated dose of Regorafenib in combination with Nivolumab in advanced, refractory colorectal cancers.
- Response Rate [ Time Frame: Every 2nd cycle (Cycles are 28 days) up to 12 months ]To access response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Overall Survival (OS) [ Time Frame: Up to 24 months after conclusion of treatment ]Occurrence of Overall Survival
- Frequency and Severity of Adverse Events [ Time Frame: Up to 12 months ]To evaluate the frequency and severity of adverse events and tolerability of the combination regimen.
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): NCT03712943
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Kaitlyn Clark 813-745-8091 Kaitlyn.Clark@moffitt.org|
|Principal Investigator: Dae W Kim, MD|
|Sub-Investigator: Richard Kim, MD|
|Principal Investigator:||Dae W Kim, MD||H. Lee Moffitt Cancer Center and Research Institute|