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A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma

ConditionsGastric CancerEsophagogastric Junction CancerEsophageal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.

Participants will:

* Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy. * Make visits to the clinic for checkups and tests. * Answer questions about their health throughout the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma that has been histologically confirmed to be predominant adenocarcinoma.

Have not been treated with systemic anticancer agents for advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.

Participants who have received neoadjuvant or adjuvant therapy may be included if no residual tumors are found after surgery (R0 resection) and if the therapy was completed at least 180 days before the date of recurrence.

Have measurable or nonmeasurable disease, as defined in Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1, and documented on computed tomography (CT) or magnetic resonance imaging (MRI) images within 42 days before Cycle 1 Day 1 (C1D1).

Disqualifiers

Participants with Human epidermal growth factor 2 (HER2)-positive or indeterminate gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma as determined by local testing. Determination for HER2 positivity is made based on the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry (IHC), or 2+ by IHC and positive by in situ hybridization.

Participants whose tumors have known microsatellite instability-high or mismatch repair-deficient status.

Marked malnutrition requiring continuous enteral nutrition or intravenous hyperalimentation, or continuous infusion therapy with hospitalization.

Active autoimmune disease, or history of autoimmune disease that might recur, that may affect vital organ function, or that may require immune-suppressive treatment, including systemic corticosteroids.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ONO-4578

    Drug

    ONO-4578 will be administered to participants at a specified dose once daily.

  • Placebo

    Other intervention

    Matching placebo for ONO-4578 will be administered to participants once daily.

  • Nivolumab

    Drug

    Nivolumab will be administered to participants at a specified dose on specified days.

  • Oxaliplatin

    Drug

    Oxaliplatin will be administered to participants at a specified dose on specified days.

  • Capecitabine

    Drug

    Capecitabine will be administered to participants at a specified dose on specified days.

  • Tegafur-gimeracil-oteracil potassium (S-1)

    Drug

    S-1 will be administered to participants at a specified dose on specified days.

  • Fluorouracil

    Drug

    Fluorouracil will be administered to participants at a specified dose on specified days.

  • Leucovorin Calcium

    Drug

    Leucovorin Calcium will be administered to participants at a specified dose on specified days.

  • Levoleucovorin

    Drug

    Levoleucovorin will be administered to participants at a specified dose on specified days.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: ONO-4578 + Nivolumab + ChemotherapyExperimental treatment 8 interventions
Group B: Placebo + Nivolumab + ChemotherapyActive comparator 8 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 4 years
2

Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

Time frame
Up to approximately 4 years

Secondary outcomes

1

PFS per Investigator Assessment

Time frame
Up to approximately 4 years
2

Objective Response Rate (ORR) per BICR

Time frame
Up to approximately 4 years
3

Duration of Response (DOR) per BICR

Time frame
Up to approximately 4 years
4

Disease Control Rate (DCR) per BICR

Time frame
Up to approximately 4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Deciphera Pharmaceuticals, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: