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RecruitingLast updated: 2 February 2024

STAR-221: This study is comparing the effectiveness of different types of immunotherapy when they are given in addition to chemotherapy in people with previously untreated locally advanced or metastatic cancer of the stomach, gastro-oesophageal junction or oesophagusA Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. Both arms will involve treatment with immunotherapy and chemotherapy. In the Experimental Arm, participants will receive immunotherapy (domvanalimab and zimberelimab) plus chemotherapy (either FOLFOX or CAPOX). Participants in this arm will either receive domvanalimab and zimberelimab doses once every 4 weeks in addition to chemotherapy with FOLFOX once every 2 weeks, or domvanalimab and zimberelimab once every 3 weeks in addition to chemotherapy with CAPOX every 3 weeks. In the Active Comparator Arm, participants will receive immunotherapy (Nivolumab) plus chemotherapy (either FOLFOX or CAPOX). Participants in this arm will either receive Nivolumab every 2 weeks and FOLFOX every 2 weeks, or Nivolumab every 3 weeks and CAPOX every 3 weeks.

Conditions

This trial is treating patients with advanced or metastatic gastric, gastro-oesophageal junction, and oesophageal cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

STAR-221

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Arcus Biosciences, Inc.

Scientific Title

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Eligibility

Inclusion

  • Age >= 18 years at the time of signing the informed consent.
  • Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
  • Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
  • At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion

  • Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:

    • Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
    • Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
    • History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
    • Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
  • Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
  • Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
  • Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
  • Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.

Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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