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NCT02746796 · CITED IN SOURCE DOCUMENTS

Study of ONO-4538 in Gastric Cancer

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

Phase
PHASE2, 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 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.

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: * Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer) * Have measurable lesions as defined in RECIST Guideline Version 1.1 * ECOG PS score 0 or 1 * Have a life expectancy of at least 3 months Exclusion Criteria: * Have multiple cancers * Have a current or past history of severe hypersensitivity to any other antibody products * 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 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (BSA) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    intervention Names
    1. Drug: ONO-4538
    2. Drug: Oxaliplatin
    3. Drug: Tegafur- Gimeracil-Oteracil potassium
    label
    ONO-4538 + SOX Therapy Cohort (Part 1)
    type
    EXPERIMENTAL
  2. description
    ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1200 - 2100 mg bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    intervention Names
    1. Drug: ONO-4538
    2. Drug: Oxaliplatin
    3. Drug: Capecitabine
    label
    ONO-4538 + CapeOX Therapy Cohort (Part 1)
    type
    EXPERIMENTAL
  3. description
    With regard to the ONO-4538 + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. ONO-4538 360 mg solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    intervention Names
    1. Drug: ONO-4538
    2. Drug: Oxaliplatin
    3. Drug: Tegafur- Gimeracil-Oteracil potassium
    4. Drug: Capecitabine
    label
    ONO-4538 + chemotherapy group (Part 2)
    type
    EXPERIMENTAL
  4. description
    With regard to the placebo + chemotherapy group, either SOX therapy or CapeOX therapy will be selected as the chemotherapy by the investigator or the subinvestigator, taking into account the condition of each subject. Placebo solution intravenously for 30 min in every 3 weeks. Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid or Capecitabine 1000 mg/ m2 (body surface area) bid orally in 14 days, followed by 7 days off. Each drug will be continued until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    intervention Names
    1. Drug: Oxaliplatin
    2. Drug: Tegafur- Gimeracil-Oteracil potassium
    3. Drug: Capecitabine
    4. Drug: Placebo
    label
    Placebo + Chemotherapy group (Part 2)
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. ONO-4538 + CapeOX Therapy Cohort (Part 1)
    2. ONO-4538 + SOX Therapy Cohort (Part 1)
    3. ONO-4538 + chemotherapy group (Part 2)
    name
    ONO-4538
    type
    DRUG
  2. arm Group Labels
    1. ONO-4538 + CapeOX Therapy Cohort (Part 1)
    2. ONO-4538 + SOX Therapy Cohort (Part 1)
    3. ONO-4538 + chemotherapy group (Part 2)
    4. Placebo + Chemotherapy group (Part 2)
    name
    Oxaliplatin
    type
    DRUG
  3. arm Group Labels
    1. ONO-4538 + SOX Therapy Cohort (Part 1)
    2. ONO-4538 + chemotherapy group (Part 2)
    3. Placebo + Chemotherapy group (Part 2)
    name
    Tegafur- Gimeracil-Oteracil potassium
    type
    DRUG
  4. arm Group Labels
    1. ONO-4538 + CapeOX Therapy Cohort (Part 1)
    2. ONO-4538 + chemotherapy group (Part 2)
    3. Placebo + Chemotherapy group (Part 2)
    name
    Capecitabine
    type
    DRUG
  5. arm Group Labels
    1. Placebo + Chemotherapy group (Part 2)
    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
680
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-free survival (central assessment by IRRC) (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 48 months)
  2. measure
    Overall survival (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
secondary Outcomes
  1. measure
    Objective response rate (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  2. measure
    Progression-free survival (assessment by the site investigator)(only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  3. measure
    Duration of response (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  4. measure
    Disease control rate (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  5. measure
    Time to response (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  6. measure
    Best overall response (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  7. measure
    Percent change in the sum of diameters of target lesions (only Part 2)
    time Frame
    Up to study completion (estimated time frame: 54 months)
  8. measure
    Safety will be analyzed through the incidence of adverse events, serious adverse events
    time Frame
    Up to 28 days from last dose
  9. measure
    Safety will be analyzed through the incidence of laboratory abnormalities
    time Frame
    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 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.
Source references
references
  1. citation
    Chen LT, Kang YK, Ryu MH, Oh DY, Oh SC, Rha SY, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy in Asian people with advanced or recurrent stomach or gastroesophageal junction cancer (ATTRACTION-4 study): a plain language summary. Future Oncol. 2026 Mar;22(6):625-642. doi: 10.1080/14796694.2026.2622806. Epub 2026 Mar 1.
    pmid
    41766168
    type
    DERIVED
  2. citation
    Boku N, Omori T, Shitara K, Sakuramoto S, Yamaguchi K, Kato K, Kadowaki S, Tsuji K, Ryu MH, Oh DY, Oh SC, Rha SY, Lee KW, Chung IJ, Sym SJ, Chen LT, Chen JS, Bai LY, Nakada T, Hagihara S, Makino R, Nishiyama E, Kang YK. Nivolumab plus chemotherapy in patients with HER2-negative, previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: 3-year follow-up of the ATTRACTION-4 randomized, double-blind, placebo-controlled, phase 3 trial. Gastric Cancer. 2024 Nov;27(6):1287-1301. doi: 10.1007/s10120-024-01535-0. Epub 2024 Aug 20.
    pmid
    39162872
    type
    DERIVED
  3. citation
    Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.
    pmid
    35030335
    type
    DERIVED
  4. citation
    Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.
    pmid
    30566590
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        </a> section.[<a href="#cit/section_4.45">45</a>]</li><li> The role of nivolumab in combination with chemotherapy was also assessed in <a href="/clinicaltrials/NCT02746796">ATTRACTION-4</a> (NCT02746796), a randomized, multicenter, double-blind, placebo-controlled, phase III trial. The study enrolled patients with previously untr
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        tion_4.45">45</a>]</li><li> The role of nivolumab in combination with chemotherapy was also assessed in <a href="/clinicaltrials/NCT02746796">ATTRACTION-4</a> (NCT02746796), a randomized, multicenter, double-blind, placebo-controlled, phase III trial. The study enrolled patients with previously untreated (except for neoadjuvant o
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      source update dates
      1. context
        Updated: March 21, 2025
        datetime
        2025-03-21T12:00:00Z
        display
        March 21, 2025

    Preserved source evidence · Not medical advice