A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

NCT05568095
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,040
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Lead sponsor
Arcus Biosciences, Inc.
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Start date
2022-11-21
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Number of sites
168
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Summary
This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
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Acronym
STAR-221
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Short title
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
clinicaltrials.gov
Official 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-08-01
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First posted
2022-10-05
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Registry last updated
2026-07-31
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Primary completion date
2026-08-01
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Start date
2022-11-21
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Actual participants
1,040
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Participants
1,040
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
168
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Arcus Biosciences, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05568095
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ClinicalTrials.gov ID
NCT05568095
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Overall survival

    Timeframe: From date of randomization until date of death from any cause (Approximately 15 months)]

  1. Progression-free survival (PFS)

    Timeframe: From date of randomization to date of the first documentation of disease progression or date of death from any cause, whichever comes first (Approximately 15 months)

  2. Objective response rate (ORR)

    Timeframe: Proportion of randomized participants who achieved a confirmed best overall response of complete response (CR) or partial response (PR) (Approximately 15 months)

  3. Duration of response (DOR)

    Timeframe: From the date of first confirmed response (CR or PR), until the date of first documented disease progression or date of death from any cause, whichever comes first (Approximately 15 months)

  4. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Timeframe: From on or after the date of first dose of any study treatment to the date of last study treatment specific safety follow-up or date of initiation of subsequent systemic anti-cancer therapy, whichever occurs first (Approximately 15 months)

  5. Time to first symptom deterioration in the FACT-Ga gastric cancer subscale.

    Timeframe: From the date of randomization to change from baseline in subscale greater than or equal to the deterioration threshold, or death from any cause, whichever comes first (Approximately 15 months)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • 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 status of 0-1.
  • At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Key Exclusion Criteria:

  • 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 completion of neoadjuvant or adjuvant therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • Research SiteLos Angeles, United States
  • Research SiteOrange, United States
  • Research SiteSanta Monica, United States
  • Research SiteNew Haven, United States
  • Research SiteWashington D.C., United States
  • Research SiteFort Myers, United States
  • Research SiteSt. Petersburg, United States
  • Research SiteTallahassee, United States
  • Research SiteLouisville, United States
  • Research SiteLouisville, United States
  • Research SiteNew Orleans, United States
  • Research SiteBoston, United States
  • Research SiteAnn Arbor, United States
  • Research SiteSaint Louis Park, United States
  • Research SiteMineola, United States
  • Research SiteNew York, United States
  • Research SiteNew York, United States
  • Research SiteDurham, United States
  • Research SiteCleveland, United States
  • Research SiteCleveland, United States
  • Research SiteColumbus, United States
  • Research SiteMayfield Heights, United States
  • Research SitePortland, United States
  • Research SiteNashville, United States
  • Research SiteNashville, United States

And 143 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • jRCT2051220179
  • MOH_2023-04-30_012590
  • 2023-507522-16-00
  • CTR20233469
Sources for references
clinicaltrials.gov

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