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A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

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ClinicalTrials.gov Identifier: NCT05329766
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : May 2, 2024
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Gastrointestinal Tract Malignancies Drug: Domvanalimab Drug: Quemliclustat Drug: Zimberelimab Drug: Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)
Actual Study Start Date : June 10, 2022
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A1: First Line - Treatment Naïve Participants
Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Fluorouracil
Administered as specified in the treatment arm

Drug: Leucovorin
Administered as specified in the treatment arm

Drug: Oxaliplatin
Administered as specified in the treatment arm
Experimental: A2: First Line - Treatment Naïve Participants
Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W
 Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Fluorouracil
Administered as specified in the treatment arm

Drug: Leucovorin
Administered as specified in the treatment arm

Drug: Oxaliplatin
Administered as specified in the treatment arm
Experimental: A3 First Line - Treatment Naïve Participants

Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W.

After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W

 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Fluorouracil
Administered as specified in the treatment arm

Drug: Leucovorin
Administered as specified in the treatment arm

Drug: Oxaliplatin
Administered as specified in the treatment arm
Experimental: A4 First Line - Treatment Naïve Participants
Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
 Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Fluorouracil
Administered as specified in the treatment arm

Drug: Leucovorin
Administered as specified in the treatment arm

Drug: Oxaliplatin
Administered as specified in the treatment arm
Experimental: B1: Second Line or greater Checkpoint Inhibitor Naïve Participants
Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm
Experimental: B2: Second Line or greater Checkpoint Inhibitor Naïve Participants
Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion
 Drug: Quemliclustat
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm
Experimental: Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants
Domvanalimab and zimberelimab Q3W administered by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 18 months ]
  2. Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 18 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) as measured by PD-L1 Expression Level [ Time Frame: Up to 18 months ]
  2. Overall survival (OS) [ Time Frame: From date of first dose until the date of death due to any cause (approximately 18 months) ]
  3. Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 [ Time Frame: Up to 18 months ]
  4. Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks [ Time Frame: Up to 18 months ]
  5. Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 [ Time Frame: Up to 18 months ]
  6. Plasma concentration of domvanalimab [ Time Frame: Up to 18 months ]
  7. Plasma concentration of zimberelimab [ Time Frame: Up to 18 months ]
  8. Plasma concentration of quemliclustat [ Time Frame: Up to 18 months ]
  9. Percentage of participants with anti-drug antibodies to domvanalimab [ Time Frame: Up to 18 months ]
  10. Percentage of participants with anti-drug antibodies to zimberelimab [ Time Frame: Up to 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
  • Eastern cooperative oncology group (ECOG) Performance Score of 0-1
  • At least one measurable target lesion per RECIST v1.1.
  • Adequate organ and marrow function
  • Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing

Key Exclusion Criteria:

  • Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
  • Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
  • Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
  • Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
  • History of trauma or major surgery within 28 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05329766


Contacts
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Contact: Medical Director +1-510-462-3330 ClinicalTrials@arcusbio.com

Locations
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Sponsors and Collaborators
Arcus Biosciences, Inc.
Gilead Sciences
Investigators
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Study Director: Medical Director Arcus Biosciences, Inc.
More Information
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Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05329766    
Other Study ID Numbers: ARC-21
2021-006291-16 ( EudraCT Number )
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
URL: https://trials.arcusbio.com/our-transparency-policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcus Biosciences, Inc.:
Domvanalimab
Quemliclustat
Zimberelimab
Esophageal adenocarcinoma
Gastric adenocarcinoma
 Gastric cancer
Gastroesophageal junction cancer
Anti-PD-1 antibody
Anti-CD73
anti-TIGIT antibody
Additional relevant MeSH terms:
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Neoplasms
Leucovorin
Oxaliplatin
Fluorouracil
Quemliclustat
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological