Clinical trial NCT06256328: A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Official title: A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).


Eligibility criteria: Inclusion Criteria:

* Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
* Patients have not been treated with systemic chemotherapy as first-line therapy
* Patients who can provide tumor tissue samples

Exclusion Criteria:

* Patients unable to take oral medicines
* Patients with HER2-positive
* Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
* Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment
* Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
* Patients with headache and/or nausea associated with brain metastasis

Primary outcomes:
measure: Progression-free survival (PFS) (site investigator assessment)
timeFrame: up to 2years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 2years
measure: Objective response rate (ORR) (site investigator assessment)
timeFrame: up to 2years
measure: Best overall response (BOR) (site investigator assessment)
timeFrame: up to 2years
measure: Duration of response (DOR) (site investigator assessment)
timeFrame: up to 2years
measure: Disease control rate (DCR) (site investigator assessment)
timeFrame: up to 2years
measure: Time to response (TTR) (site investigator assessment)
timeFrame: up to 2years
measure: Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
timeFrame: up to 2years
measure: Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
timeFrame: up to 2years
measure: Adverse event (AE)
timeFrame: Up to 30 days after the last dose
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital
state: Ehime
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Cancer Center
state: Fukuoka
city: Yahatanishi-ku, Kitakyusyu-shi
country: Japan
facility: JCHO Kyushu Hospital
state: Fukuoka
city: Ota-shi
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Hiroshima
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyogo
city: Amagasaki-shi
country: Japan
facility: JOHAS Kansai Rosai Hospital
state: Hyougo
city: Kasama-shi
country: Japan
facility: Ibaraki Prefectural Central Hospital
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Yahaba-cho, Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Miki-cho, Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Osaki-shi
country: Japan
facility: Osaki Citizen Hospital
state: Miyagi
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Chuo-ku
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Sayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Sumiyoshi-ku
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Ina-machi, Kitaadati-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Nagaizumi-cho, Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
city: Minato-Ku
country: Japan
facility: IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Gangwon-do
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk national university hospital
state: Jeollabuk-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: