臨床研究等提出・公開システム

Date of registration	July. 31, 2026
Last modified on	July. 31, 2026
Trial ID	jRCT2061260044

Scientific Title	Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)
Public Title	Solid tumorRollover Study (CA239-0071)

Contact for Scientific Queries	Name	Ahmad Harris
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Ahmad Harris
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 20, 2026
Target sample size		170
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit. 2) Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.
	Exclusion Criteria	1) Participant is not eligible for study treatment per the parent study eligibility criteria. 2) Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study. 3) Participants not receiving clinical benefit from parent study drug as assessed by the investigator. Other protocol defined inclusion/exclusion criteria applies.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Solid Tumors
Intervention(s)		Arm A1, A2: Adagrasib Arm B1, B2: Adagrasib + Pembrolizumab; Arm B3: Adagrasib + Cetuximab; Arm B4: Adagrasib + Pembrolizumab + Pemetrexed Arm C1: Pembrolizumab; Arm C2: Docetaxel; Arm C3: Irinotecan + Leucovorin + Fluorouracil; Arm C4: Oxaliplatin + Leucovorin + Fluorouracil Drugs: Adagrasib, Pembrolizumab, Cetuximab, Pemetrexed, Docetaxel, Irinotecan, Leucovorin, Oxaliplatin, Fluorouracil
Primary Outcome(s)		Long-term safety of adagrasib administered as monotherapy or in combination with other cancer therapies: incidence of treatment-related adverse events (AEs), AEs leading to discontinuation, serious adverse events (SAEs), and death

Primary Sponsor	Bristol-Myers Squibb

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board,Ehime University Hospital
Address	454 Shitsukawa, Toon, Ehime , Ehime
Telephone	+81-89-960-5172
E-Mail	rinri@m.ehime-u.ac.jp
Approval Status	Not approval

Plan to share IPD	Yes
Plan description	BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Secondary ID(s)	NCT07415031
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Belgium/Canada/China/France/Germany/Greece/Hungary/Israel/Italy/Netherlands/Poland/Portugal/Romania/Singapore/South Korea/Spain/United Kingdom/United States