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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT05568095
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced Upper Gastrointestinal Tract Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Domvanalimab — DRUG
    Intravenous (IV) Aqueous Solution
  • Zimberelimab — DRUG
    IV Aqueous Solution
  • Capecitabine — DRUG
    Oral Tablets
  • Fluorouracil — DRUG
    IV Aqueous Solution
  • Leucovorin — DRUG
    IV Aqueous Solution
  • Oxaliplatin — DRUG
    IV Aqueous Solution
  • Nivolumab — DRUG
    IV Aqueous Solution

Study Details

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.

Key Dates

Start date
Nov 21, 2022
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,040 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
    Participants in this arm will receive Domvanalimab and zimberelimab doses once every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX (oxaliplatin, leucovorin, fluorouracil) once every 2 weeks (Q2W) or Domvanalimab and zimberelimab once every 3 weeks (Q3W) in addition to chemotherapy with CAPOX (capecitabine and oxaliplatin) Q3W.
  • Active Comparator: Nivolumab + FOLFOX/CAPOX (PI Choice)
    Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.

Primary Outcome Measure

Overall survival [ Time Frame: From date of randomization until date of death from any cause (Approximately 15 months)] ]

Locations (31)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90033-
Research SiteOrangeCalifornia92868-
Research SiteSanta MonicaCalifornia90404-
Research SiteNew HavenConnecticut06520-
Research SiteWashington D.C.District of Columbia22057-
Research SiteFort MyersFlorida33901-
Research SiteSt. PetersburgFlorida33705-
Research SiteTallahasseeFlorida32308-
Research SiteLouisvilleKentucky40202-
Research SiteLouisvilleKentucky40217-
Research SiteNew OrleansLouisiana70121-
Research SiteBostonMassachusetts02114-
Research SiteAnn ArborMichigan48109-
Research SiteSaint Louis ParkMinnesota55426-
Research SiteMineolaNew York11501-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SiteDurhamNorth Carolina27710-
Research SiteClevelandOhio44106-
Research SiteClevelandOhio44111-
Research SiteColumbusOhio43219-
Research SiteMayfield HeightsOhio44124-
Research SitePortlandOregon97225-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37232-
Research SiteDallasTexas75390-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77054-
Research SiteFairfaxVirginia22031-
Research SiteSeattleWashington98109-
Research SiteMilwaukeeWisconsin53226-

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