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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

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