Clinical trial · Interventional
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)
NCT05696548CI-TRIAL-00107689active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Thyroid Cancer | Thyroid Gland Anaplastic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenvatinib plus Nivolumab
- description
- Step 1: 3 patients, Step 2: 48 patients
- interventionNames
- Drug: Lenvatinib
- Drug: Nivolumab
Primary outcomes (2)
- measure
- Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
- timeFrame
- up to 28 days
- description
- Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT
- measure
- Step 2: Objective Response Rate (ORR)
- timeFrame
- Up to 12 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.