Regorafenib and Nivolumab Simultaneous Combination Therapy

Conditions

• Advanced and Metastatic Solid Tumor

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Regorafenib — DRUG
  One course will last 28 days. Oral administration for 21 consecutive days, with a 1-week washout period. As for the expansion cohort, implemented using the RD estimated in the dose-escalation cohort.
• Nivolumab — DRUG
  One course will last 28 days. Given once every 2 weeks at a dose of 3.0 mg/kg.

Study Details

the efficacy and safety ofhe use of regorafenib in combination with nivolumab

Key Dates

Start date

Jan 15, 2018

Status verified

Dec 2024

Primary completion

Dec 15, 2020

Completion

Dec 15, 2020

Study Design

Enrollment

50 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Level 1
  Regorafenib: Oral administration at a dose of 80 mg given once per day for 21 consecutive days, with a 1-week washout period. Nivolumab: Given once every 2 weeks at a dose of 3.0 mg/kg via an intravenous infusion. When it is deemed that there is no problem with safety at the doses described above, tolerability will be verified at the level-2 dosages described below.
• Active Comparator: Level 2
  Regorafenib: Oral administration at a dose of 120 mg/day for 21 consecutive days, with a 1-week washout period. Nivolumab: Given once every 2 weeks at a dose of 3.0 mg/kg. When it is deemed that there is no problem with safety at the doses described above, tolerability will be verified at the level-3 dosages described below.
• Active Comparator: Level 3
  Regorafenib: Oral administration at a dose of 160 mg/day for 21 consecutive days, with a 1-week washout period. Nivolumab: Given once every 2 weeks at a dose of 3.0 mg/kg. After starting the trial, three cases are registered at level 1, and temporary case registration is suspended until safety evaluation of the first course is completed in all cases. If there are cases in which evaluation of DLT can not be performed properly, such as being canceled due to reasons other than safety during the course of the first course, the necessary number of cases is appropriately added to the administration level.
• Active Comparator: Expansion cohort
  After completion of the final DLT evaluation period of the subjects in the dose escalating cohort, the decision to move the subjects into the expansion cohort will be determined once it is decided, upon deliberation between the sponsor and the principal investigator, that there are no problems associated with moving on. Furthermore, the opinion of the Data and Safety Monitoring Committee (DSMC) can be sought as required . Regarding the review of RD in the expansion cohort, please refer to "Analysis Population Description" in Primary Outcome Measures.

Primary Outcome Measure

The Number of Dose Limiting Toxicity (DLT) for RD Determination [ Time Frame: 4 weeks ]