Clinical trial NCT05329766: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Tract Malignancies
Keywords: Domvanalimab
Quemliclustat
Zimberelimab
Esophageal adenocarcinoma
Gastric adenocarcinoma
Gastric cancer
Gastroesophageal junction cancer
Anti-PD-1 antibody
Anti-CD73
anti-TIGIT antibody
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2022-04-15
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 18 months
measure: Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 18 months
Secondary outcomes:
measure: Objective Response Rate (ORR) as measured by PD-L1 Expression Level
timeFrame: Up to 18 months
measure: Overall survival (OS)
timeFrame: From date of first dose until the date of death due to any cause (approximately 18 months)
measure: Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 18 months
measure: Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks
timeFrame: Up to 18 months
measure: Duration of response (DOR) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 18 months
measure: Plasma concentration of domvanalimab
timeFrame: Up to 18 months
measure: Plasma concentration of zimberelimab
timeFrame: Up to 18 months
measure: Plasma concentration of quemliclustat
timeFrame: Up to 18 months
measure: Percentage of participants with anti-drug antibodies to domvanalimab
timeFrame: Up to 18 months
measure: Percentage of participants with anti-drug antibodies to zimberelimab
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Derby
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialist - South
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist - North
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: OU - Stephenson Cancer Center
state: Oklahoma
city: Nashville
country: United States
facility: SCRI Tennessee Oncology - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Toronto
country: Canada
facility: UHN - Princess Margaret Cancer Centre
city: Las Condes
country: Chile
facility: Clínica San Carlos de Apoquindo
city: Recoleta
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA
city: Talca
country: Chile
facility: Clínica Universidad Católica del Maule
city: Bordeaux
country: France
facility: Institut Bergonié _ Bordeaux
city: Brest
country: France
facility: CHU de Brest_Brest
city: Caen Cedex 5
country: France
facility: Centre Baclesse - CAEN
city: Lille Cedex
country: France
facility: Centre Oscar Lambret _ LILLE
city: Lyon
country: France
facility: Centre Léon Bérard _ Lyon
city: Marseille
country: France
facility: Hôpital Timone - Marseille
city: Montpellier Cedex 5
country: France
facility: Institut de Recherche en Cancerologie de Montpellier
city: Plerin
country: France
facility: Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie
city: Poitiers
country: France
facility: Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse_Oncopole
city: Villejuif
country: France
facility: Gustave Roussy - Villejuif
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Cancer Center
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital, The Catholic University of Korea
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Belgrade
country: Serbia
facility: MSB - Medicinski Sistem Beograd
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Hospital Medical Center (KBC) Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute of Oncology of Vojvodina
Study officials:
affiliation: Arcus Biosciences, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: