Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Sponsor
National Cancer Center Hospital East
Study ID
NCT05696548
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Anaplastic Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
  • Nivolumab — DRUG
    Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks

Study Details

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.

Key Dates

Start date
Jul 2, 2019
Status verified
Apr 2026
Primary completion
Sep 10, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib plus Nivolumab
    Step 1: 3 patients, Step 2: 48 patients

Primary Outcome Measure

Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT) [ Time Frame: up to 28 days ]

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