Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

• ClinicalTrials.gov Identifier: NCT02267343
• Recruitment Status: Completed
• First Posted: October 17, 2014
• Last Update Posted: May 3, 2024
• Sponsor: Ono Pharmaceutical Co. Ltd
• Information provided by (Responsible Party): Ono Pharmaceutical Co. Ltd

Tracking Information

• First Submitted Date: October 9, 2014
• First Posted Date: October 17, 2014
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: October 2014
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 14, 2014): Overall survival [ Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 14, 2014)

• Progression-free survival [ Time Frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle ]
• Objective response rate [ Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle ]
• Duration of response [ Time Frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle ]
• Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]
• Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 28 days from last dose ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
• Official Title: ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
• Brief Summary: The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• Drug: ONO-4538
• Drug: Placebo

Study Arms

• Experimental: ONO-4538 Arm
  ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  Intervention: Drug: ONO-4538
• Placebo Comparator: Placebo Arm
  Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  Intervention: Drug: Placebo

Publications *

• Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.
• Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 19, 2021): 493
• Original Estimated Enrollment (submitted: October 14, 2014): 480
• Actual Study Completion Date: January 2021
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Men & women ≥20 years of age
• Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)
• Histologically confirmed adenocarcinoma
• Refractory to or intolerant of standard therapy
• ECOG Performance Status score 0 or 1
• A life expectancy of at least 3 months

Exclusion Criteria:

• Current or past history of severe hypersensitivity to any other antibody products
• Patients with multiple primary cancers
• Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
• Patients with active, known or suspected autoimmune disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, Korea, Republic of, Taiwan

Administrative Information

• NCT Number: NCT02267343
• Other Study ID Numbers: ONO-4538-12
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ono Pharmaceutical Co. Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Ono Pharmaceutical Co. Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Mitsunobu Tanimoto; Ono Pharmaceutical Co. Ltd

• PRS Account: Ono Pharmaceutical Co. Ltd
• Verification Date: May 2024