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NCT02267343 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2024-05-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 Names
    1. Drug: ONO-4538
    label
    ONO-4538 Arm
    type
    EXPERIMENTAL
  2. description
    Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    intervention Names
    1. Drug: Placebo
    label
    Placebo Arm
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. ONO-4538 Arm
    name
    ONO-4538
    type
    DRUG
  2. arm Group Labels
    1. Placebo Arm
    name
    Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
493
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
    time Frame
    Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
secondary Outcomes
  1. measure
    Progression-free survival
    time Frame
    Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
  2. measure
    Objective response rate
    time Frame
    Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
  3. measure
    Duration of response
    time Frame
    Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
  4. measure
    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
  5. measure
    Safety will be analyzed through the incidence of laboratory abnormalities
    time Frame
    Continuously throughout study treatment and up to 28 days from last dose
Full study description
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.
Source references
references
  1. citation
    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.
    pmid
    35383114
    type
    DERIVED
  2. citation
    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.
    pmid
    28993052
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        ):</p> <div class="pdq-content-list"><ol id="_685"><li>A randomized, double-blinded, placebo-controlled, phase III trial (<a href="/clinicaltrials/NCT02267343">ONO-4538-12 </a> [ATTRACTION-2] [NCT02267343]) enrolled 493 patients with refractory gastroesophageal/gastric cancer from Japan, South Korea, and Taiwan.[<a h
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      2. context exact
        t"><ol id="_685"><li>A randomized, double-blinded, placebo-controlled, phase III trial (<a href="/clinicaltrials/NCT02267343">ONO-4538-12 </a> [ATTRACTION-2] [NCT02267343]) enrolled 493 patients with refractory gastroesophageal/gastric cancer from Japan, South Korea, and Taiwan.[<a href="#cit/section_8.38">38</a>] Patients were
        end
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      source retrieved at
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      source string sha256
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      source title
      Gastric Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 21, 2025
        datetime
        2025-02-21T12:00:00Z
        display
        February 21, 2025

    Preserved source evidence · Not medical advice