We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05329766
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : May 17, 2023
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a Phase 2, open-label, parallel 3-cohort, multicenter study 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-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 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and any Clinically meaningful trends in safety parameters [ 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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.

Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Medical Director +1-510-462-3330 ClinicalTrialInquiry@arcusbio.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
Arcus Biosciences, Inc.
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Medical Director Arcus Biosciences, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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 17, 2023
Last Verified: May 2023
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.
URL: https://trials.arcusbio.com/our-transparency-policy

Layout table for additional information
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:
Layout table for MeSH terms
Neoplasms
Leucovorin
Fluorouracil
Oxaliplatin
Quemliclustat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological