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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 ID: NCT05696548
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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Cancer Center, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Hokkaido University Hospital, Hokkaido, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Nippon Medical School Hospital, Tokyo, , Japan
Name: Makoto Tahara, MD, PhD
Affiliation: National Cancer Center Hospital East
Role: STUDY_DIRECTOR
Name: Iwao Sugitani, MD, PhD
Affiliation: Nippon Medical School Hospital
Role: STUDY_CHAIR
Name: Naomi Kiyota, MD, PhD
Affiliation: Kobe University Hospital
Role: STUDY_CHAIR