Anaplastic Thyroid Cancer
Conditions
Keywords
Nivolumab, Lenvatinib, Anaplastic Thyroid Cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGLenvatinib
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
DRUGNivolumab
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks
Sponsors
National Cancer Center Hospital East
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed as anaplastic thyroid cancer 2. Unresectable anaplastic thyroid cancer 3. Have measurable lesions defined by the RECIST version 1.1 4. Have adequate organ function 5. Cardiac function test within 28 days before enrollment 12-lead electrocardiogram no clinically significant abnormality as shown below: heart disease, severe arrhythmia, etc. 6. Patients who are 20 years or older 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 8. Ability to swallow oral medications 9. Women of childbearing potential 10. Life expectancy of more than 90 days 11. Have signed written informed consent to participate in this study
Exclusion criteria
1. Active brain metastases or leptomeningeal metastases 2. Diverticulitis or Symptomatic ulcerative disease 3. Treatment required complication of systemic infectious disease 4. Medical history of active, known, or suspected autoimmune disease 5. Complication of pulmonary fibrosis or interstitial pneumonitis 6. Medical history of clinically significant cardiovascular disease within 180 days of initial dose as New York Heart Association (NYHA) class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment 7. Regardless of usage of antihypertensive drug, systolic blood pressure \<=140 mm Hg and diastolic blood pressure \<=90 mm Hg 8. Have active double cancer 9. Currently receiving other interventional clinical study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT) | up to 28 days | Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT |
| Step 2: Objective Response Rate (ORR) | Up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of adverse events | Up to 12 months | For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0 |
| Overall Survival (OS) | Up to 12 months | The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause. |
| Progression-Free Survival (PFS) | Up to 12 months | The registration date is the starting date, and is defined as the period until the progressive disease (PD) or death of any cause occurs. |
| Best Overall Response (BOR) | Up to 12 months | BOR is the best response recorded from the start of the study treatment until the end of treatment |
| Disease Control Rate (DCR) | Up to 12 months | DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD). |
| Clinical Benefit Rate (CBR) | Up to 12 months | DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months. |
| Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L) | Up to 12 months | Quality of life will be evaluated by EQ-5D-5L |
Countries
Japan
Contacts
STUDY_DIRECTORMakoto Tahara, MD, PhD
National Cancer Center Hospital East
STUDY_CHAIRIwao Sugitani, MD, PhD
Nippon Medical School Hospital
STUDY_CHAIRNaomi Kiyota, MD, PhD
Kobe University Hospital
Outcome results
None listed