Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

NCT05696548 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: YCU18001JapicCTI-194835
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Anaplastic Thyroid Cancer

Keywords

Nivolumab; Lenvatinib; Anaplastic Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 12 months

Secondary Outcomes (7)

• Proportion of adverse events

  Up to 12 months

• Overall Survival (OS)

  Up to 12 months

• Progression-Free Survival (PFS)

  Up to 12 months

• Best Overall Response (BOR)

  Up to 12 months

• Disease Control Rate (DCR)

  Up to 12 months

Study Arms (1)

Lenvatinib plus Nivolumab

EXPERIMENTAL

Step 1: 3 patients, Step 2: 48 patients

Drug: Lenvatinib; Drug: Nivolumab

Interventions

Lenvatinib DRUG

Lenvatinib will be administered at a dose of 24mg as oral dose, one a day

Lenvatinib plus Nivolumab

Nivolumab DRUG

Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks

Lenvatinib plus Nivolumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center Hospital East: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (10)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Hokkaido University Hospital

Hokkaido, Hokkaido, 060-8648, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka, 545-8586, Japan

Location

National Cancer Center Hospital

Tokyo, Tokyo, 104-0045, Japan

Location

Nippon Medical School Hospital

Tokyo, Tokyo, 113-8603, Japan

Location

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Interventions

lenvatinib; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Makoto Tahara, MD, PhD

  National Cancer Center Hospital East

  STUDY DIRECTOR

• Iwao Sugitani, MD, PhD

  Nippon Medical School Hospital

  STUDY CHAIR

• Naomi Kiyota, MD, PhD

  Kobe University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Head and Neck Medical Oncology

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: July 2, 2019
• Primary Completion: September 10, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)