Trials / Active Not Recruiting
Active Not RecruitingNCT05696548
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- National Cancer Center Hospital East · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Lenvatinib will be administered at a dose of 24mg as oral dose, one a day |
| DRUG | Nivolumab | Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks |
Timeline
- Start date
- 2019-07-02
- Primary completion
- 2025-09-10
- Completion
- 2026-12-01
- First posted
- 2023-01-25
- Last updated
- 2026-04-09
Locations
10 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05696548. Inclusion in this directory is not an endorsement.