Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION) (NCT05696548) | Clinical Trial Compass
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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
. 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