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OpenTrials
Active, Not Recruiting

NCT Number: NCT05696548

Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anaplastic Thyroid Cancer Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Thyroid Carcinoma, Anaplastic

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

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About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Women of childbearing potential
  • Life expectancy of more than 90 days
  • Have signed written informed consent to participate in this study

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Proportion of adverse events

    Time frame: Up to 12 months

    For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0

  2. Overall Survival (OS)

    Time frame: Up to 12 months

    The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.

  3. Progression-Free Survival (PFS)

    Time frame: Up to 12 months

    The registration date is the starting date, and is defined as the period until the progressive disease (PD) or death of any cause occurs.

  4. Best Overall Response (BOR)

    Time frame: Up to 12 months

    BOR is the best response recorded from the start of the study treatment until the end of treatment

  5. Disease Control Rate (DCR)

    Time frame: Up to 12 months

    DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD).

  6. Clinical Benefit Rate (CBR)

    Time frame: Up to 12 months

    DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months.

  7. Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)

    Time frame: Up to 12 months

    Quality of life will be evaluated by EQ-5D-5L

Sponsors and collaborators

Lead sponsor

National Cancer Center Hospital East

Other

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jan 25, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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