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Chemotherapy

Combination Immunotherapy + Chemotherapy for Gastric Cancer (STAR-221 Trial)

Phase 3
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new combination of drugs to help the immune system fight advanced stomach and esophagus cancers. It compares two new drugs plus chemotherapy against an existing drug plus chemotherapy to see which works better.

Who is the study for?
This trial is for adults with advanced gastric, GEJ, or esophageal adenocarcinoma that can't be surgically removed and has spread. Participants must have a good performance status (able to carry out daily activities), at least one measurable lesion, and no prior treatments for this cancer stage.
What is being tested?
The study tests new drugs Domvanalimab (TIGIT inhibitor) and Zimberelimab (PD-1 inhibitor) with chemotherapy against Nivolumab (another PD-1 inhibitor) with chemo in first-line treatment. It's randomized, meaning patients are assigned to groups by chance.
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation of organs, infusion reactions similar to allergic responses, fatigue, nausea from chemotherapy agents used alongside the tested drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)Experimental Treatment6 Interventions
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.
Group II: Nivolumab + FOLFOX/CAPOX (PI Choice)Active Control5 Interventions
Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~6010
Oxaliplatin
2011
Completed Phase 4
~2890
Capecitabine
2013
Completed Phase 3
~3970
Fluorouracil
2014
Completed Phase 3
~11700
Zimberelimab
2020
Completed Phase 2
~230

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for gastric cancer include chemotherapy and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, but it can also affect normal cells, leading to side effects. Immunotherapy, such as the use of monoclonal antibodies like domvanalimab (TIGIT monoclonal antibody) and zimberelimab (anti-PD-1), works by enhancing the body's immune response against cancer cells. Domvanalimab blocks the TIGIT pathway, which can inhibit immune suppression and promote T-cell activity against tumors. Zimberelimab targets the PD-1 pathway, preventing cancer cells from evading immune detection. These treatments are crucial for gastric cancer patients as they offer targeted approaches that can potentially improve outcomes and reduce side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Taiho Pharmaceutical Co., Ltd.Industry Sponsor
65 Previous Clinical Trials
17,190 Total Patients Enrolled
Arcus Biosciences, Inc.Lead Sponsor
42 Previous Clinical Trials
6,046 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,129 Previous Clinical Trials
866,543 Total Patients Enrolled

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05568095 — Phase 3
Gastric Cancer Research Study Groups: Nivolumab + FOLFOX/CAPOX (PI Choice), Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Gastric Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05568095 — Phase 3
Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05568095 — Phase 3
~457 spots leftby May 2026