Zimberelimab + Domvanalimab for Stomach and Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the combination of two immune therapy drugs, domvanalimab and zimberelimab, alongside standard chemotherapy to determine their safety and effectiveness in treating certain stomach and esophageal cancers. Participants will receive these treatments for up to 4 months before surgery, followed by additional immune therapy for up to 8 months post-surgery. The trial seeks individuals who have not yet received treatment for their stomach or gastroesophageal junction cancer and have been informed that their cancer is operable. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer therapy.
Will I have to stop taking my current medications?
The trial requires participants to be treatment naïve, meaning you cannot have received prior treatments for your cancer. If you are on medications for other conditions, the protocol does not specify if you need to stop them, but you should discuss this with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of domvanalimab and zimberelimab with chemotherapy has been well-studied in patients with advanced stomach and gastroesophageal cancers. Studies have found that most people can tolerate this combination without serious problems. Previous trials reported no unexpected safety issues. The overall response rate (ORR), which measures how well tumors shrink or disappear, was about 59%. Patients lived for a median of 26.7 months, which is promising.
These findings suggest the treatment is relatively safe, especially since no new safety concerns have emerged. However, like any medical treatment, side effects can occur. Discuss any concerns with a healthcare provider before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about zimberelimab and domvanalimab for stomach and esophageal cancer because these treatments work by harnessing the immune system in a unique way. Unlike traditional chemotherapy, which directly targets cancer cells, zimberelimab and domvanalimab are monoclonal antibodies that help the immune system recognize and attack cancer cells more effectively. This approach targets specific proteins that usually help cancer cells evade the immune system, potentially leading to more precise and less toxic treatment. As a result, these therapies could offer a new hope for patients by improving outcomes and reducing side effects compared to standard chemotherapy options like fluorouracil, oxaliplatin, leucovorin, and docetaxel.
What evidence suggests that zimberelimab and domvanalimab might be effective treatments for stomach and esophageal cancer?
Research shows that the combination of domvanalimab and zimberelimab holds promise for treating stomach and esophageal cancers. In earlier studies, this combination achieved a 59% success rate in shrinking tumors in patients with advanced gastroesophageal cancer. Patients receiving this treatment lived for a median of 26.7 months, and the median time before the cancer worsened was 12.9 months. In this trial, participants will receive domvanalimab and zimberelimab along with neoadjuvant FLOT therapy. These early results suggest that the treatment can effectively slow cancer progression and extend patient survival.12678
Who Is on the Research Team?
Samuel J. Klempner, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for patients with operable esophageal, stomach, or gastroesophageal junction cancer. Participants will undergo standard chemotherapy combined with two immune therapy drugs before and after surgery. The study requires a commitment of up to 5 years including treatment and follow-up.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive up to 8 cycles of domvanalimab, zimberelimab, and FLOT chemotherapy before surgery
Surgery and Recovery
Participants undergo surgical resection and recover for 4-12 weeks
Adjuvant Treatment
Participants receive domvanalimab and zimberelimab for up to 8 cycles post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Domvanalimab
- Zimberelimab
Trial Overview
The effectiveness and safety of combining domvanalimab and zimberelimab with FLOT chemotherapy are being tested in this study. Patients receive these treatments for four months pre-surgery, then continue the immune therapies for eight more months post-surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will receive up to 8 2-week cycles of domvanalimab, zimberelimab and FLOT (fluorouracil (5-FU), oxaliplatin, leucovorin, and docetaxel) via intravenous infusion (IV). If there is no evidence of progressive disease and patients remain good surgical candidates, they will undergo curative intent surgical resection as per standard of care. Beginning 4-12 weeks after surgery, patients will receive domvanalimab + zimberelimab via IV for up to 8 28-day cycles. Participants will be followed for up to 5 years.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Arcus Biosciences, Inc.
Industry Sponsor
Gateway for Cancer Research
Collaborator
Citations
Domvanalimab and zimberelimab in advanced gastric ...
After a median study follow-up of 26.4 months, outcomes were encouraging, with an ORR of 59%, median DOR of 12.4 months, median PFS of 12.9 ...
Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab ...
Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of ...
3.
targetedonc.com
targetedonc.com/view/domvanalimab-combo-shows-enriched-first-line-efficacy-in-advanced-gi-cancersDomvanalimab Combo Shows Enriched First-Line Efficacy ...
The combination of domvanalimab and zimberelimab showed a 59% objective response rate in advanced HER2-negative gastroesophageal cancer patients ...
EDGE Gastric Study at ESMO 2025: Domvanalimab ...
At 26 months of follow-up, dual PD-1/TIGIT blockade with domvanalimab and zimberelimab plus FOLFOX achieved prolonged survival outcomes—with a ...
EDGE-Gastric Trial: Breaking Down Data for ...
They outline key efficacy signals, including durability of response, and progression-free survival trends, while also commenting on the safety ...
Zimberelimab + Domvanalimab in Gastroesophageal ...
This is a single-center, phase II study evaluating the efficacy, activity and safety of domvanalimab and zimberelimab with standard chemotherapy ...
Phase 3 STAR-221 Study of First-Line Domvanalimab ...
The confirmed ORR per RECIST 1.1 criteria was 59% (90% CI, 45%-72%). No unexpected safety signals were observed at the time of data cutoff, and ...
EDGE-Gastric Arm A1: Phase 2 study of domvanalimab ...
There was an even distribution of pts accrued in Asia vs. rest of world and 63% of pts had gastric cancer. Median time on treatment was 23 weeks (1 to 40), 31 ...
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