A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

NCT ID: NCT04933227

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-06
• Study Completion Date: 2023-11-17

Brief Summary

This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ AC).

Conditions

Stomach Neoplasms; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atezo + Tira + XELOX

Atezolizumab plus tiragolumab in combination with XELOX (oxaliplatin and capecitabine) will be administered during Cycles 1-4 (each cycle is 21 days). During Cycle 5 and beyond atezolizumab and tiragolumab will be administered on Day 1 of each 21-day cycle. Participants will receive study treatment until disease progression, unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.

Tiragolumab

Intervention Type: DRUG

Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 130 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.

Capecitabine

Intervention Type: DRUG

Capecitabine 1000 mg/m\^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.

Interventions

Atezolizumab

Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Tiragolumab

Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 130 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.

Intervention Type: DRUG

Capecitabine

Capecitabine 1000 mg/m\^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.

Intervention Type: DRUG

Other Intervention Names

Tecentriq

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed (by enrolling center) gastric cancer or adenocarcinoma of GEJ (Siewert I-III)
• Unresectable locally advanced, unresectable recurrent, or metastatic disease that meets the following criteria: a) No prior systemic treatment for advanced disease, b) For patients receiving prior chemoradiotherapy or chemotherapy in the adjuvant or neoadjuvant setting, with an interval of at least 6 months between the final treatment and the diagnosis of advanced disease
• Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as determined by investigator assessment
• Availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT expression
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy >/=3 months
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to refrain from heterosexual intercourse or use contraception, and agreement to refrain from donating eggs
• For men: agreement to refrain from heterosexual intercourse or use contraceptive methods, and agreement to refrain from donating sperm.

Exclusion Criteria

• HER2-positive by local review, defined as either immunohistochemistry (IHC) score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed based on pretreatment tumor tissues
• Use of Chinese herbal medicine or Chinese patent medicines to control cancer within 7 days prior to initiation of study treatment
• Higher risk of bleeding or fistula caused by GEJ Siewert I invading adjacent organs
• Symptomatic, untreated, or actively progressing CNS metastases
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Uncontrolled or symptomatic hypercalcemia
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
• Severe chronic or active infection within 4 weeks prior to initiation of study treatment
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
• Any other disease, medical condition, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination finding, clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
• Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-TIGIT therapeutic antibodies
• Treatment with systemic immunostimulatory agents or any investigational therapy within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
• Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
• Known allergy or hypersensitivity to any component of atezolizumab, tiragolumab, capecitabine or oxaliplatin formulations
• Pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing Cancer Hospital

Beijing, , China

Jilin Cancer Hospital

Changchun, , China

Hunan Cancer Hospital

Changsha, , China

Changzhou First People's Hospital

Changzhou, , China

The First Affiliated Hospital of College of Medicine, Zhejiang University; Medical Oncology

Hangzhou, , China

The First Affiliated Hospital of Anhui Medical University

Hefei, , China

Anhui Province Cancer Hospital

Hefei, , China

Liaoning cancer Hospital & Institute

Shenyang, , China

Tianjin Cancer Hospital

Tianjin, , China

Hubei Cancer Hospital

Wuhan, , China

The First Affiliated Hospital of Xiamen University

Xiamen, , China

Countries

China

Other Identifiers

ML42913

Identifier Type: -

Identifier Source: org_study_id