This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.
This study is an open-label phase 2 study to evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer according to the following steps. Step 1 will evaluate the dose-limiting toxicities (DLT) of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer. Step 2 will evaluate the safety and efficacy of Nivolumab plus Lenvatinib in patients with unresectable anaplastic thyroid cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hokkaido University Hospital
Hokkaido, Hokkaido, Japan
Hyogo Cancer Center
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT
Time frame: up to 28 days
Step 2: Objective Response Rate (ORR)
ORR will be defined as the proportion of patients achieving complete response (CR) and partial response (PR) as determined according to RECIST ver1.1 by a central review
Time frame: Up to 12 months
Proportion of adverse events
For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0
Time frame: Up to 12 months
Overall Survival (OS)
The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.
Time frame: Up to 12 months
Progression-Free Survival (PFS)
The registration date is the starting date, and is defined as the period until the progressive disease (PD) or death of any cause occurs.
Time frame: Up to 12 months
Best Overall Response (BOR)
BOR is the best response recorded from the start of the study treatment until the end of treatment
Time frame: Up to 12 months
Disease Control Rate (DCR)
DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD).
Time frame: Up to 12 months
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Akashi, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
National Cancer Center Hospital
Tokyo, Tokyo, Japan
Nippon Medical School Hospital
Tokyo, Tokyo, Japan
Clinical Benefit Rate (CBR)
DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months.
Time frame: Up to 12 months
Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)
Quality of life will be evaluated by EQ-5D-5L
Time frame: Up to 12 months