Anaplastic Thyroid CancerPhase 2NCT05696548
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
A Phase 2 study testing Lenvatinib and Nivolumab in people with Anaplastic Thyroid Cancer, run by National Cancer Center Hospital East at 10 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anaplastic Thyroid Cancer
- What is being tested?
- Lenvatinib and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 10 sitesJapan
- Study dates
- 2 Jul 2019to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Ability to swallow oral medications
- Women of childbearing potential
- Life expectancy of more than 90 days
- Have signed written informed consent to participate in this study
Who cannot join
- 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
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- Regardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hg and diastolic blood pressure <=90 mm Hg
- Have active double cancer
- Currently receiving other interventional clinical study treatment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
Hokkaido University Hospital
Hokkaido, Hokkaido, 060-8648
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Cancer Center Hospital
Tokyo, Tokyo, 104-0045
Nippon Medical School Hospital
Tokyo, Tokyo, 113-8603
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
About this study
Official title: Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)
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.
Read the 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.
- Conditions
- Anaplastic Thyroid Cancer
- Being tested
- Lenvatinib, Nivolumab
- Keywords
- Nivolumab, Lenvatinib, Anaplastic Thyroid Cancer
- Medical subject headings
- Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
NivolumabDrug
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib plus Nivolumab | Experimental | Step 1: 3 patients, Step 2: 48 patients Receives: Drug: Lenvatinib; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT
Measured: up to 28 days
Step 2: Objective Response Rate (ORR)
ORR will be defined as the proportion of patients achieving complete response (CR) and partial response (PR) as determined according to RECIST ver1.1 by a central review
Measured: Up to 12 months
Secondary outcomes (7)
Proportion of adverse events
For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0
Measured: Up to 12 months
Overall Survival (OS)
The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.
Measured: Up to 12 months
Progression-Free Survival (PFS)
The registration date is the starting date, and is defined as the period until the progressive disease (PD) or death of any cause occurs.
Measured: Up to 12 months
Best Overall Response (BOR)
BOR is the best response recorded from the start of the study treatment until the end of treatment
Measured: Up to 12 months
Disease Control Rate (DCR)
DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD).
Measured: Up to 12 months
Clinical Benefit Rate (CBR)
DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months.
Measured: Up to 12 months
Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)
Quality of life will be evaluated by EQ-5D-5L
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start2 Jul 2019
- Primary completion10 Sep 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Hospital East
- Sponsor type
- University, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Makoto Tahara, National Cancer Center Hospital East
- Investigators
- Makoto Tahara, MD, PhD, Study director, National Cancer Center Hospital EastIwao Sugitani, MD, PhD, Study chair, Nippon Medical School HospitalNaomi Kiyota, MD, PhD, Study chair, Kobe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696548
- Sponsor's protocol ID
- YCU18001
- Other IDs
- JapicCTI-194835
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)
- ClinicalTrials.gov ID
- NCT05696548
- Acronym / sponsor ID
- YCU18001
- Conditions
- Anaplastic Thyroid Cancer
- Keywords
- Nivolumab, Lenvatinib, Anaplastic Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Cancer Center Hospital EastUniversity, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib plus Nivolumab | Experimental | Drug: Lenvatinib, Drug: NivolumabStep 1: 3 patients, Step 2: 48 patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibLenvatinib will be administered at a dose of 24mg as oral dose, one a day | Drug | Lenvatinib plus Nivolumab |
| NivolumabNivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks | Drug | Lenvatinib plus Nivolumab |
Primary outcome
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
Time frame: up to 28 days
Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT
Step 2: Objective Response Rate (ORR)
Time frame: Up to 12 months
ORR will be defined as the proportion of patients achieving complete response (CR) and partial response (PR) as determined according to RECIST ver1.1 by a central review
7 secondary outcomes
Proportion of adverse events
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 12 months
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Best Overall Response (BOR)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 12 months
Clinical Benefit Rate (CBR)
Time frame: Up to 12 months
Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Makoto Tahara, MD, PhD study director
National Cancer Center Hospital East
Iwao Sugitani, MD, PhD study chair
Nippon Medical School Hospital
Naomi Kiyota, MD, PhD study chair
Kobe University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib and Nivolumab in people with Anaplastic Thyroid Cancer, run by National Cancer Center Hospital East at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT) (time frame: up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.