Regorafenib and Nivolumab in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT04030260|
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : September 17, 2019
REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months.
Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to explore the safety and efficacy of regorafenib and nivolumab in combination with radiotherapy with or without irinotecan in previously treated metastatic colorectal cancer patients with pMMR/MSS.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic MSS||Drug: Regorafenib and Nivolumab in Combination with Radiotherapy Radiation: Radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regorafenib and Nivolumab in Combination With Radiotherapy With or Without Irinotecan in Patients With pMMR/MSS and Previously Treated Metastatic Colorectal Cancer：a Multicentre, Phase 2 Trial|
|Actual Study Start Date :||July 19, 2019|
|Estimated Primary Completion Date :||July 19, 2020|
|Estimated Study Completion Date :||July 19, 2020|
|Experimental: Regorafenib and Nivolumab in Combination with Radiotherapy||
Drug: Regorafenib and Nivolumab in Combination with Radiotherapy
Regorafenib will be given 3 weeks on/1 week off (80 mg od po.) and Nivolumab administered IV at a dose of 3mg/kg every 2 weeks with or without irinotecan administered IV at a fixed dose of 80-100mg every 2 weeks
Radiation: Radiation therapy
Radiation therapy is believed to increase the likelihood of response of immunotherapy
- The progression-free survival (PFS) rates at 6 months [ Time Frame: 2 year ]The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment. The PFS rates at 6 months was estimated from Kaplan-Meier curves.
- The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR). [ Time Frame: 2 year ]
- Overall Survival (OS) [ Time Frame: 2 year ]OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
- Disease Control Rate (DCR) [ Time Frame: 2 year ]DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)
- Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 2 year ]
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): NCT04030260
|Contact: Yanhong Deng, M.D.||firstname.lastname@example.org|
|The Sixth Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Yanhong Deng, M.D. 86-13925106525 email@example.com|
|Principal Investigator:||Yanhong Deng, M.D.||Sixth Affiliated Hospital, Sun Yat-sen University|