Clinical trial NCT05696548: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Anaplastic Thyroid Cancer
Keywords: Nivolumab
Lenvatinib
Anaplastic Thyroid Cancer
Lead sponsor: National Cancer Center Hospital East
Sponsor class: OTHER
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2023-01-25
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Step 1: Proportion of subjects with Dose-Limiting Toxicities (DLT)
timeFrame: up to 28 days
measure: Step 2: Objective Response Rate (ORR)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Proportion of adverse events
timeFrame: Up to 12 months
measure: Overall Survival (OS)
timeFrame: Up to 12 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 12 months
measure: Best Overall Response (BOR)
timeFrame: Up to 12 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 12 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 12 months
measure: Quality of life by EuroQol 5 dimensions 5-level (EQ-5D-5L)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
Study officials:
affiliation: National Cancer Center Hospital East
name: Makoto Tahara, MD, PhD
role: STUDY_DIRECTOR
affiliation: Nippon Medical School Hospital
name: Iwao Sugitani, MD, PhD
role: STUDY_CHAIR
affiliation: Kobe University Hospital
name: Naomi Kiyota, MD, PhD
role: STUDY_CHAIR
References: