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Chemotherapy
Combination Immunotherapy + Chemotherapy for Gastric Cancer (STAR-221 Trial)
Phase 3
Recruiting
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 approximately 15 months
Awards & highlights
STAR-221 Trial Summary
This trial compares 3 treatments for advanced stomach cancer to see which is most effective.
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.Check my eligibility
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.See study design
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.
STAR-221 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Duration of response (DOR)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Objective response rate (ORR)
+1 moreSTAR-221 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
Oxaliplatin
2011
Completed Phase 4
~2560
Capecitabine
2013
Completed Phase 3
~3420
Leucovorin
2005
Completed Phase 4
~5730
Fluorouracil
2014
Completed Phase 3
~11540
Zimberelimab
2018
Completed Phase 1
~50
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Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,096 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
842,509 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,777 Previous Clinical Trials
8,062,918 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer is in the stomach, GEJ, or esophagus and cannot be surgically removed.I am fully active or can carry out light work.I can sign and understand the consent form for the trial.I do not have any health conditions that would make the study treatment dangerous for me.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + FOLFOX/CAPOX (PI Choice)
- Group 2: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the chances of serious adverse effects for patients taking Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)?
"Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice) is a Phase 3 trial, which means that there is available data to support both efficacy and safety. Our team has given it a safety rating of 3."
Answered by AI
How many test subjects are being recruited for this experiment?
"That is correct. According to information found on clinicaltrials.gov, this research is still recruiting individuals. This study was first advertised on November 1st, 2022 and updated on November 2nd, 2022. A total of 970 people are needed between 1 location."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
What questions have other patients asked about this trial?
Can it be done remotely as he is not in US at this time?
PatientReceived no prior treatments
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