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A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Ono Pharmaceuticals logo

Ono Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

Gastric Cancer

Treatments

Drug: Oxaliplatin
Drug: Nivolumab
Drug: Capecitabine
Drug: Placebo
Drug: ONO-4578
Drug: S-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT06256328
ONO-4578-08

Details and patient eligibility

About

This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Enrollment

210 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
  • Patients have not been treated with systemic chemotherapy as first-line therapy
  • Patients who can provide tumor tissue samples

Exclusion criteria

  • Patients unable to take oral medicines
  • Patients with HER2-positive
  • Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
  • Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
  • Patients with headache and/or nausea associated with brain metastasis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

210 participants in 2 patient groups, including a placebo group

ONO-4578+Nivolumab+chemotherapy
Experimental group
Treatment:
Drug: S-1
Drug: ONO-4578
Drug: Capecitabine
Drug: Nivolumab
Drug: Oxaliplatin
placebo+Nivolumab+chemotherapy
Placebo Comparator group
Treatment:
Drug: S-1
Drug: Placebo
Drug: Capecitabine
Drug: Nivolumab
Drug: Oxaliplatin

Trial contacts and locations

63

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Central trial contact

Ono Pharmaceutical Co., Ltd.

Data sourced from clinicaltrials.gov

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