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Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

Primary Purpose

Anaplastic Thyroid Cancer

Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Lenvatinib
Nivolumab
Sponsored by
National Cancer Center Hospital East
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Thyroid Cancer focused on measuring Nivolumab, Lenvatinib, Anaplastic Thyroid Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer CenterRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Hyogo Cancer CenterRecruiting
  • Kobe University HospitalRecruiting
  • Yokohama City University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • National Cancer Center HospitalRecruiting
  • Nippon Medical School HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenvatinib plus Nivolumab

Arm Description

Step 1: 3 patients, Step 2: 48 patients

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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.
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.
Best Overall Response (BOR)
BOR is the best response recorded from the start of the study treatment until the end of treatment
Disease Control Rate (DCR)
DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD).
Clinical Benefit Rate (CBR)
DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months.
Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)
Quality of life will be evaluated by EQ-5D-5L

Full Information

First Posted
January 13, 2023
Last Updated
January 13, 2023
Sponsor
National Cancer Center Hospital East
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05696548
Brief Title
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
Official Title
Phase 2 Study of Nivolumab Plus Lenvatinib for Patients With Unresectable Anaplastic Thyroid Cancer (NAVIGATION Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2019 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center Hospital East
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Thyroid Cancer
Keywords
Nivolumab, Lenvatinib, Anaplastic Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib plus Nivolumab
Arm Type
Experimental
Arm Description
Step 1: 3 patients, Step 2: 48 patients
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
Lenvatinib will be administered at a dose of 24mg as oral dose, one a day
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab will be administered at a dose of 240mg as a 30-minutes IV infusion, every 2 weeks
Primary Outcome Measure Information:
Title
Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
Description
Proportion of subjects with DLT will be defined as the proportion of patients who developed DLT
Time Frame
up to 28 days
Title
Step 2: Objective Response Rate (ORR)
Description
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
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Proportion of adverse events
Description
For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0
Time Frame
Up to 12 months
Title
Overall Survival (OS)
Description
The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.
Time Frame
Up to 12 months
Title
Progression-Free Survival (PFS)
Description
The registration date is the starting date, and is defined as the period until the progressive disease (PD) or death of any cause occurs.
Time Frame
Up to 12 months
Title
Best Overall Response (BOR)
Description
BOR is the best response recorded from the start of the study treatment until the end of treatment
Time Frame
Up to 12 months
Title
Disease Control Rate (DCR)
Description
DCR will be defined as the proportion of patients achieving CR, PR or stable disease (SD).
Time Frame
Up to 12 months
Title
Clinical Benefit Rate (CBR)
Description
DCR will be defined as the proportion of patients achieving CR, PR or SD lasting at least 11 months.
Time Frame
Up to 12 months
Title
Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)
Description
Quality of life will be evaluated by EQ-5D-5L
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Makoto Tahara, MD, PhD
Phone
+81-47133-1111
Email
matahara@east.ncc.go.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Tahara, MD, PhD
Organizational Affiliation
National Cancer Center Hospital East
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Iwao Sugitani, MD, PhD
Organizational Affiliation
Nippon Medical School Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naomi Kiyota, MD, PhD
Organizational Affiliation
Kobe University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigenori Kadowaki, MD, PhD
Email
skadowaki@aichi-cc.jp
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Tahara, MD, PhD
Phone
+81-47133-1111
Email
matahara@east.ncc.go.jp
Facility Name
Hyogo Cancer Center
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Matsumoto, MD
Email
kojmatsu-chiken@hyogo-cc.jp
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naomi Kiyota, MD, PhD
Email
nkiyota@med.kobe-u.ac.jp
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Motohiko Tokuhisa, MD, PhD
Email
tokuhisa@yokohama-cu.ac.jp
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Saijo, MD, PhD
Email
ken.saijo.d6@tohoku.ac.jp
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasushi Shimizu, MD, PhD
Email
y-simz@med.hokudai.ac.jp
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuyuki Kajimoto, MD
Email
b21799e@omu.ac.jp
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshitaka Honma, MD
Email
yohonma@ncc.go.jp
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iwao Sugitani, MD, PhD
Email
isugitani@nms.ac.jp

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)

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