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Trial Title:
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
NCT ID:
NCT05696548
Condition:
Anaplastic Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Thyroid Diseases
Nivolumab
Lenvatinib
Conditions: Keywords:
Nivolumab
Lenvatinib
Anaplastic Thyroid Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
Arm group label:
Lenvatinib plus Nivolumab
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2
weeks
Arm group label:
Lenvatinib plus Nivolumab
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya
Zip:
464-8681
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Facility:
Name:
Hyogo Cancer Center
Address:
City:
Akashi
Zip:
673-8558
Country:
Japan
Facility:
Name:
Kobe University Hospital
Address:
City:
Kobe
Zip:
650-0017
Country:
Japan
Facility:
Name:
Yokohama City University Hospital
Address:
City:
Yokohama
Zip:
236-0004
Country:
Japan
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai
Zip:
980-8574
Country:
Japan
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Hokkaido
Zip:
060-8648
Country:
Japan
Facility:
Name:
Osaka Metropolitan University Hospital
Address:
City:
Osaka
Zip:
545-8586
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Facility:
Name:
Nippon Medical School Hospital
Address:
City:
Tokyo
Zip:
113-8603
Country:
Japan
Start date:
July 2, 2019
Completion date:
July 2025
Lead sponsor:
Agency:
National Cancer Center Hospital East
Agency class:
Other
Collaborator:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
National Cancer Center Hospital East
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05696548
