Regorafenib and Nivolumab Simultaneous Combination Therapy (REGONIVO)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03406871|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2018
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced and Metastatic Solid Tumor||Drug: Regorafenib Drug: Nivolumab||Phase 1 Phase 2|
The present trial consists of a dose-escalation cohort to verify the tolerability of nivolumab and regorafenib when used in combination for patients with solid tumors, and to examine the clinical recommended dose(RD). The trial also consists of an expansion cohort to examine the safety and efficacy when the clinical RD is administered for several advanced solid tumors.
In the dose-escalation cohort, three patients with solid tumors will be administered 3.0 mg/kg of nivolumab once every 2 weeks and regorafenib daily for 21days, with a 1-week washout period at dose of 80 mg (level 1), 120 mg (level 2), or 160 mg (level 3). As a general rule, one cycle will last 28 days (day 1-29); however, in the event of treatment prolongation, the cycle period will be extended. The Dose Limiting Toxicity(DLT) evaluation period will be 28 days. Furthermore, for each level, three additional subjects will be added depending on the state of DLT.
In the expansion cohort, the target subject sample will consist of approximately 30 patients who will be administered 3.0 mg/kg of nivolumab once every 2 weeks, and the clinical RD of regorafenib will be determined in the dose-escalation cohort.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Regorafenib and Nivolumab Simultaneous Combination Therapy for Advanced and Metastatic Solid Tumors: Phase I Clinical Trial|
|Actual Study Start Date :||January 25, 2018|
|Actual Primary Completion Date :||October 23, 2019|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: Nivolumab + Regorafenib
Nivolumab and Regorafenib
One course will last 28 days. Oral administration at a dose of 80 mg/day, 120mg/day or 160 mg/day for 21 consecutive days, with a 1-week washout period.
Other Name: Regorafenib (BMS-936558, MDX1106, ONO-4538)
One course will last 28 days. Given once every 2 weeks at a dose of 3.0 mg/kg.
Other Name: Nivolumab (BAY73-4506)
- RD [ Time Frame: 4 weeks ]Recommended Dose of Regorafenib
- Maximum Tolerated Dose(MTD) [ Time Frame: 4 weeks ]Maximum tolerated dose
- ORR [ Time Frame: 1year ]Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
- Progression-Free Survival(PFS) [ Time Frame: 1year 6 months ]Progression-free survival
- Overall Survival(OS) [ Time Frame: 1year 6 months ]Overall survival
- Disease Control Rate(DCR) [ Time Frame: 1year ]Disease control rate
- Incidence of Treatment-Emergent Adverse-Events [Safety and Tolerability] [ Time Frame: 1year 6 months ]Incidence of adverse events
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): NCT03406871
|Kashiwa, Chiba, Japan, 277-8577|
|Study Chair:||Kohei Shitara, Dr||National Cancer Center Hospital East|