332 Participants Needed

Immunotherapy + Chemotherapy for Gastrointestinal Cancer

(EDGE-Gastric Trial)

Recruiting at 84 trial locations
MD
Overseen ByMedical Director
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What safety data exists for the combination of fluorouracil, leucovorin, and oxaliplatin in cancer treatment?

The combination of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) is generally safe but can cause side effects like low white blood cell counts (neutropenia), nerve damage (neuropathy), nausea, diarrhea, and mouth sores. Some patients may experience severe side effects, and allergic reactions are rare but possible.12345

What makes the drug combination of Domvanalimab, Fluorouracil, Leucovorin, Oxaliplatin, and Zimberelimab unique for gastrointestinal cancer?

This treatment is unique because it combines immunotherapy (Domvanalimab and Zimberelimab) with chemotherapy (Fluorouracil, Leucovorin, and Oxaliplatin), potentially enhancing the immune system's ability to fight cancer while also directly targeting cancer cells, which is different from standard chemotherapy regimens that do not include immunotherapy.26789

What data supports the effectiveness of the drug combination used in the Immunotherapy + Chemotherapy for Gastrointestinal Cancer trial?

Research shows that combining oxaliplatin with 5-fluorouracil (5-FU) and leucovorin significantly improves response rates and survival in patients with advanced colorectal cancer. This suggests that similar combinations could be effective for gastrointestinal cancers.12101112

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Arcus Biosciences, Inc.

Are You a Good Fit for This Trial?

Adults with advanced cancers of the upper gastrointestinal tract, specifically gastric, GEJ, and esophageal adenocarcinoma that can't be surgically removed or has spread. They should be relatively active (ECOG score 0-1), have a life expectancy of at least 3 months, measurable cancer lesions, good organ function, and provide a tumor sample for testing.

Inclusion Criteria

I have advanced stomach or esophagus cancer and am expected to live at least 3 more months.
At least one measurable target lesion per RECIST v1.1
I can provide a sample of my cancer for testing.
See 2 more

Exclusion Criteria

Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
I am in Cohort A and my tumor is HER-2 positive.
I stopped previous immune therapy due to side effects; I've had anti-TIGIT treatment.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment combinations with and without chemotherapy, including FOLFOX and immunotherapy agents like domvanalimab and zimberelimab

12-24 weeks
Bi-weekly visits for chemotherapy, monthly visits for immunotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Domvanalimab
  • Fluorouracil
  • Leucovorin
  • Oxaliplatin
  • Zimberelimab
Trial Overview The study is testing combinations of new drugs Quemliclustat, Zimberelimab, Domvanalimab with/without standard chemotherapy FOLFOX (Fluorouracil + Leucovorin + Oxaliplatin) in three different groups to see which works best for treating these cancers.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced ParticipantsExperimental Treatment2 Interventions
Group II: B2: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimental Treatment2 Interventions
Group III: B1: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimental Treatment2 Interventions
Group IV: A4 First Line - Treatment Naïve ParticipantsExperimental Treatment4 Interventions
Group V: A3 First Line - Treatment Naïve ParticipantsExperimental Treatment5 Interventions
Group VI: A2: First Line - Treatment Naïve ParticipantsExperimental Treatment4 Interventions
Group VII: A1: First Line - Treatment Naïve ParticipantsExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arcus Biosciences, Inc.

Lead Sponsor

Trials
44
Recruited
7,500+

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

The combination of oxaliplatin and irinotecan with continuous infusion of 5FU has significantly improved treatment outcomes for metastatic colorectal cancer, leading to better response rates and overall survival compared to earlier treatments.
The ongoing trials, such as Optimox2, are exploring strategies to reduce treatment cycles and toxicity while maintaining efficacy, alongside promising new targeted therapies against EGFR and VEGF, which could further enhance treatment options.
[Reflexion on a good strategy of use of oxaliplatine with 5-fluorouracil and its derivatives in patients with advanced colorectal cancer].Tournigand, C., de Gramont, A.[2018]
In a study of 11 patients with advanced or metastatic colorectal cancer, the FOLFOX4 regimen showed a 0% response rate, while mFOLFOX6 had a 71% response rate as a first-line therapy, indicating that mFOLFOX6 is more effective.
Patients who responded to FOLFOX4/mFOLFOX6 or FOLFIRI had significantly longer survival times (7 to 27 months) compared to those who did not respond (4 to 8 months), suggesting that these treatments can be effective for improving outcomes in this patient population.
Efficacy and toxicity of fluorouracil, leucovorin plus oxaliplatin (FOLFOX4 and modified FOLFOX6) followed by fluorouracil, leucovorin plus irinotecan(FOLFIRI)for advanced or metastatic colorectal cancer--case studies.Ohtani, H., Arimoto, Y., Nishio, K., et al.[2016]
In a phase III study involving 220 previously untreated patients with metastatic colorectal cancer, both treatment sequences (FOLFIRI followed by FOLFOX6 and vice versa) resulted in similar median survival rates of approximately 21.5 months and 20.6 months, indicating comparable efficacy.
The study revealed distinct toxicity profiles for each treatment sequence, with FOLFIRI causing more mucositis and nausea/vomiting, while FOLFOX6 was associated with higher rates of neutropenia and neurosensory toxicity.
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study.Tournigand, C., André, T., Achille, E., et al.[2023]

Citations

[Reflexion on a good strategy of use of oxaliplatine with 5-fluorouracil and its derivatives in patients with advanced colorectal cancer]. [2018]
Efficacy and toxicity of fluorouracil, leucovorin plus oxaliplatin (FOLFOX4 and modified FOLFOX6) followed by fluorouracil, leucovorin plus irinotecan(FOLFIRI)for advanced or metastatic colorectal cancer--case studies. [2016]
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. [2023]
FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study. [2023]
The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study. [2021]
Cetuximab is associated with excessive toxicity when combined with bevacizumab Plus mFOLFOX6 in metastatic colorectal carcinoma. [2021]
Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. [2019]
[FOLFOX]. [2013]
S-1 for the treatment of gastrointestinal cancer. [2022]
Doxifluridine as palliative treatment in advanced gastric and pancreatic cancer patients. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
New drugs in the treatment of colorectal carcinoma. [2019]
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