Active — Not RecruitingPhase 2

Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Japan51 participantsStarted 2019-07-02

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed as anaplastic thyroid cancer
✓. Unresectable anaplastic thyroid cancer
✓. Have measurable lesions defined by the RECIST version 1.1
✓. Have adequate organ function
✓. Cardiac function test within 28 days before enrollment 12-lead electrocardiogram no clinically significant abnormality as shown below: heart disease, severe arrhythmia, etc.
✓. Patients who are 20 years or older
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Ability to swallow oral medications

Exclusion criteria

✕. Active brain metastases or leptomeningeal metastases
✕. Diverticulitis or Symptomatic ulcerative disease
✕. Treatment required complication of systemic infectious disease
✕. Medical history of active, known, or suspected autoimmune disease
✕. Complication of pulmonary fibrosis or interstitial pneumonitis
✕. 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
✕. Regardless of usage of antihypertensive drug, systolic blood pressure \<=140 mm Hg and diastolic blood pressure \<=90 mm Hg
✕. Have active double cancer

What they're measuring

Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)

Timeframe: up to 28 days

Step 2: Objective Response Rate (ORR)

Timeframe: Up to 12 months

Trial details

NCT IDNCT05696548

SponsorNational Cancer Center Hospital East

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-10

View on ClinicalTrials.gov More Anaplastic Thyroid Cancer trials