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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-194835 | Registry Identifier | JAPIC Clinical Trials Information |
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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib plus Nivolumab | Experimental | Step 1: 3 patients, Step 2: 48 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib will be administered at a dose of 24mg as oral dose, one a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Makoto Tahara, MD, PhD | National Cancer Center Hospital East | Study Director |
| Iwao Sugitani, MD, PhD | Nippon Medical School Hospital | Study Chair |
| Naomi Kiyota, MD, PhD | Kobe University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| National Cancer Center Hospital East |
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| ID | Term |
|---|---|
| D065646 | Thyroid Carcinoma, Anaplastic |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nivolumab | Drug | Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks |
|
The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.
| 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. | 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 | Up to 12 months |
| Disease Control Rate (DCR) | DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD). | Up to 12 months |
| Clinical Benefit Rate (CBR) | DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months. | 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 | Up to 12 months |
| Kashiwa |
| Chiba |
| 277-8577 |
| Japan |
| Hokkaido University Hospital | Hokkaido | Hokkaido | 060-8648 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Osaka Metropolitan University Hospital | Osaka | Osaka | 545-8586 | Japan |
| National Cancer Center Hospital | Tokyo | Tokyo | 104-0045 | Japan |
| Nippon Medical School Hospital | Tokyo | Tokyo | 113-8603 | Japan |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |