What side effects are associated with this type of intervention?

Common treatments for gastric cancer, particularly those involving immunotherapy agents like nivolumab and chemotherapy, are associated with several side effects. Immunotherapy can cause skin reactions, endocrine events, and gastrointestinal issues such as diarrhea. Chemotherapy often results in nausea, vomiting, anemia, and febrile neutropenia. Combining these treatments can increase the risk of severe adverse reactions, including pneumonia, acute kidney injury, and respiratory failure.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of gastric cancer. Notably, pembrolizumab (Keytruda), an anti-PD-1 monoclonal antibody, has been approved for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing PD-L1. Nivolumab (Opdivo), another anti-PD-1 monoclonal antibody, has also been approved for similar indications. These treatments are somewhat related to the ongoing study of domvanalimab, a TIGIT monoclonal antibody, as they all target immune checkpoints to enhance the body's immune response against cancer cells.

What other types of research exist?

Promising alternatives to Domvanalimab for gastric cancer patients include: 1) Zimberelimab (anti-PD-1 monoclonal antibody) combined with multiagent chemotherapy, 2) Nivolumab (anti-PD-1 monoclonal antibody) combined with multiagent chemotherapy, 3) Ramucirumab in combination with FLOT chemotherapy, and 4) Atezolizumab in combination with FLOT chemotherapy. These treatments are currently being evaluated in clinical trials and have shown potential efficacy in treating gastric cancer.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

~3960

Fluorouracil

2014

Completed Phase 3

~11700

Zimberelimab

2020

Completed Phase 2

~230

Do I qualify?Apply below to find out

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.