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)

NCT04933227 | Terminated Phase 2 FDA Drug

• 1 other identifier: ML42913
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population

  Up to approximately 20 months

Secondary Outcomes (12)

• Duration of Response (DOR) in Responders of the FAS Population

  The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months

• Progression-free Survival (PFS) in the FAS Population

  The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months

• Overall Survival (OS) in the FAS Population

  The time from initiation of study treatment to death due to any cause up to approximately 20 months

• Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the FAS Population

  Up to approximately 20 months

• Change from Baseline in EORTC QLQ-C30 in the FAS Population

  Up to approximately 20 months

Study Arms (1)

Atezo + Tira + XELOX

EXPERIMENTAL

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.

Drug: Atezolizumab; Drug: Tiragolumab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq

Atezo + Tira + XELOX

Tiragolumab DRUG

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

Atezo + Tira + XELOX

Oxaliplatin DRUG

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

Atezo + Tira + XELOX

Capecitabine DRUG

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

Atezo + Tira + XELOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Jilin Cancer Hospital

Changchun, 132013, China

Location

Hunan Cancer Hospital

Changsha, 410013, China

Location

Changzhou First People's Hospital

Changzhou, 213003, China

Location

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

Hangzhou, 310003, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

Location

Anhui Province Cancer Hospital

Hefei, 230031, China

Location

Liaoning cancer Hospital & Institute

Shenyang, 110042, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Hubei Cancer Hospital

Wuhan, 430079, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, 361003, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

atezolizumab; Tiragolumab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 21, 2021
• Study Start: August 6, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (11)