Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
NCT ID: NCT05696548
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
51 participants
INTERVENTIONAL
2019-07-02
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenvatinib plus Nivolumab
Step 1: 3 patients, Step 2: 48 patients
Lenvatinib
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
Nivolumab
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks
Interventions
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Lenvatinib
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
Nivolumab
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
National Cancer Center Hospital East
OTHER
Responsible Party
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Makoto Tahara
Chief, Department of Head and Neck Medical Oncology
Principal Investigators
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Makoto Tahara, MD, PhD
Role: STUDY_DIRECTOR
National Cancer Center Hospital East
Iwao Sugitani, MD, PhD
Role: STUDY_CHAIR
Nippon Medical School Hospital
Naomi Kiyota, MD, PhD
Role: STUDY_CHAIR
Kobe University Hospital
Locations
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hokkaido University Hospital
Hokkaido, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
National Cancer Center Hospital
Tokyo, Tokyo, Japan
Nippon Medical School Hospital
Tokyo, Tokyo, Japan
Countries
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Other Identifiers
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JapicCTI-194835
Identifier Type: REGISTRY
Identifier Source: secondary_id
YCU18001
Identifier Type: -
Identifier Source: org_study_id
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