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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04933227
Other study ID # ML42913
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 6, 2021
Est. completion date November 17, 2023

Study information

Verified date March 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date November 17, 2023
Est. primary completion date November 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab
Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.
Tiragolumab
Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.
Oxaliplatin
Oxaliplatin 130 mg/m^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.
Capecitabine
Capecitabine 1000 mg/m^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing
China Jilin Cancer Hospital Changchun
China Hunan Cancer Hospital Changsha CITY
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 City
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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population Up to approximately 20 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change from Baseline in EORTC QLQ-C30 in the FAS Population Up to approximately 20 months
Secondary Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire in Gastric Cancer (EORTC QLQ-STO22) in the FAS Population Up to approximately 20 months
Secondary Change from Baseline in EORTC QLQ-STO22 in the FAS Population Up to approximately 20 months
Secondary ORR in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression Up to approximately 20 months
Secondary Duration of Response (DOR) in Responders of a Subgroup Population With PD-L1 and/or TIGIT Positive Expression 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
Secondary Progression-free Survival (PFS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression 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
Secondary Overall Survival (OS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression The time from initiation of study treatment to death due to any cause up to approximately 20 months
Secondary Number of Participants With Adverse Events Up to approximately 20 months
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