臨床研究等提出・公開システム

Date of registration	June. 05, 2018
Last modified on	Jan. 28, 2025
Trial ID	jRCT2080223930

Scientific Title	A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
Public Title	CLOVER

Contact for Scientific Queries	Name	Hibi Kazushige
	Contact Name for Scientific Queries	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Phone Number	+81-6-4802-3533
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Contact for Public Queries	Name	Hibi Kazushige
	Contact Name for Public Queries	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Phone Number	+81-6-4802-3533
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Recruitment Status	completed

Date of First Enrolment		June. 27, 2018
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	Non-Randomized, Parallel Assignment
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-World Health Organization (WHO)/ECOG performance status of 0 or 1 -Body weight > 30 kg at enrollment and treatment assignment -At least 1 measurable lesion, not previously irradiated -No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines) -For patients with oropharyngeal HNSCC HPV status has to be known
	Exclusion Criteria	Patients with simultaneous primary malignancies or bilateral tumors -Active or prior documented autoimmune or inflammatory disorders -Brain metastases or spinal cord compression -Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies) -Has a paraneoplastic syndrome (PNS) of autoimmune nature -HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded -NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology -SCLC cohort: Extensive-stage SCLC
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Carcinoma, Squamous Cell of Head and Neck Carcinoma, Non-Small-Cell Lung Small Cell Lung Carcinoma
Intervention(s)		investigational material(s) Generic name etc : Durvalumab, Tremelimumab, Cisplatin, Carboplatin, Etoposide, Paclitaxel, Pemetrexed, Radiation: External beam radiation INN of investigational material : - Therapeutic category code : 4-- Agents affecting cellular function Dosage and Administration for Investigational material : Intravenous injection control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety -
Secondary Outcome		efficacy -

Primary Sponsor	Astrazeneca K.K
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Shizuoka Cancer Center Ethical Review Board for Business Clinical Trial Studies
Address of IRB	1007 Shimonagakubo, Nagaizumi-cho , Sunto-gun, Shizuoka
Phone Number of IRB	+81-55-989-5222
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	June. 07, 2018

Secondary ID No.	NCT03509012
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-183987
Name of Other Registries

Countries / Regions of Recruitment	South Korea/Taiwan/Spain/United States of America

History of Changes

No	Publication date
5	Jan. 28, 2025	(this page)	Changes
4	May. 15, 2020	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	June. 05, 2018	Detail	Changes
1	June. 05, 2018	Detail

List of change history