Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center Hospital East
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Lenvatinib; Nivolumab

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