anaplastic thyroid cancer
Conditions
Interventions
Dosage and Administration for Investigational material :
Nivolumab 240mg IV every 2 weeks.The first dose will be administered in the hospital for 14 days.
Lenvatinib will be administered orally once d
Sponsors
National Cancer Center Hospital East, Department of Head and Neck Medical Oncology, Makoto Tahara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed as anaplastic thyroid cancer 2. Unresectable anaplastic thyroid cancer 3. Have measurable lesion defined by the RECIST version 1.1 4. Have adequate organ function 5. Cardiac function test within 28 days prior to enrollment 12-lead electrocardiogram no clinically important abnormality as shown below: heart disease, severe arrhythmia etc. 6. Patients who are 20 years or older 7. ECOG performance status 0-1 8. Ability to swallow oral medications 9. Women of childbearing potential 10.Life expectancy more than 90 days 11.Have signed written informed consent to participate in this study
Exclusion criteria
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: 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 |
|---|---|
| safety efficacy Proportion of subjects with DLT Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Proportion of adverse events Overall Survival (OS) Progression-Free Survival (PFS) Best Overall Response (BOR) Disease Control Rate (DCR) Clinical Benefit Rate (CBR) Quality of life | — |
Countries
Japan
Contacts
Public ContactOrie Watanabe
Yokohama City University hospital
Outcome results
None listed