Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Anaplastic Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05696548
• Other study ID #: YCU18001
• Secondary ID: JapicCTI-194835
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2, 2019
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: National Cancer Center Hospital East
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaplastic Thyroid Cancer
• Thyroid Carcinoma, Anaplastic
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	Hokkaido University Hospital	Hokkaido
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	National Cancer Center Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	Yokohama City University Hospital	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center Hospital East	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Proportion of adverse events	For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0	Up to 12 months
Secondary	Overall Survival (OS)	The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.	Up to 12 months
Secondary	Progression-Free Survival (PFS)	The registration date is the starting date, and is defined as the period until the progressive disease (PD) or death of any cause occurs.	Up to 12 months
Secondary	Best Overall Response (BOR)	BOR is the best response recorded from the start of the study treatment until the end of treatment	Up to 12 months
Secondary	Disease Control Rate (DCR)	DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD).	Up to 12 months
Secondary	Clinical Benefit Rate (CBR)	DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months.	Up to 12 months
Secondary	Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)	Quality of life will be evaluated by EQ-5D-5L	Up to 12 months