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A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction

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ClinicalTrials.gov Identifier: NCT04661150
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a phase II, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of perioperative trastuzumab+XELOX with / without atezolizumab in participants eligible for surgery with locally advanced HER2-positive gastric cancer or adenocarcinoma of GEJ.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Adenocarcinoma Drug: Atezolizumab Drug: Trastuzumab Drug: Capecitabine Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) and Trastuzumab in Combination With Capecitabine and Oxaliplatin (Xelox) in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction (GEJ)
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Arm A: Atezolizumab plus Trastuzumab with XELOX (Capecitabine + Oxaliplatin)
Participants will receive atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, patrticipants will receive 5 further cycles of this regimen.
Drug: Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 3 cycles prior to surgery and 5 cycles after surgery.
Other Name: Tecentriq

Drug: Trastuzumab
Trastuzumab will be administered as an 8 mg/kg IV loading dose and then 6 mg/kg IV on Day 1 of a 21-day cycle for 3 cycles before surgery, and administration will continue after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.
Other Name: Herceptin

Drug: Capecitabine
Capecitabine 1000 mg/m^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.

Drug: Oxaliplatin
Oxaliplatin 130 mg/m^2 will be administered by IV on Day 1 of a 21-day cycle.

Active Comparator: Arm B: Trastuzumab with XELOX (Capecitabine + Oxaliplatin)
Participants will receive trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants will receive 5 further cycles of this regimen.
Drug: Trastuzumab
Trastuzumab will be administered as an 8 mg/kg IV loading dose and then 6 mg/kg IV on Day 1 of a 21-day cycle for 3 cycles before surgery, and administration will continue after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.
Other Name: Herceptin

Drug: Capecitabine
Capecitabine 1000 mg/m^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.

Drug: Oxaliplatin
Oxaliplatin 130 mg/m^2 will be administered by IV on Day 1 of a 21-day cycle.




Primary Outcome Measures :
  1. Pathological Complete Regression (pCR) Rate [ Time Frame: Completion of neoadjuvant systemic therapy (up to approximately 16 months) ]
    pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist..


Secondary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: Randomization to the first documented disease recurrence, unequivocal tumor progression or death from any cause, whichever occurs first (up to approximately 52 months) ]
    Event-free survival (EFS), defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.

  2. Disease-Free Survival (DFS) [ Time Frame: Surgery to first documented disease recurrence or death from any cause, whichever occurs first (up to approximately 52 months) ]
    Disease-free survival (DFS), defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first.

  3. Overall survival (OS) [ Time Frame: Randomiation to death from any cause (up to approximately 52 months) ]
    Overall survival (OS), defined as the time from randomization to death from any cause in all patients.

  4. Major Pathologic Response (MPR) [ Time Frame: Randomization up to approximately 16 months ]
    Major pathologic response (MPR), defined as < 10% residual tumor per tumor bed based on evaluation of the resected primary esophagogastric specimen by a local pathologist.

  5. Objective Response Rate (ORR) [ Time Frame: Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months) ]
    Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) during NAST, as determined by the investigator according to RECIST v1.1.

  6. R0 Resection Rate [ Time Frame: Surgery ]
    R0 resection rate, defined as the proportion of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed and/or sampled regional lymph nodes based on evaluation by the local pathologist.

  7. Percentage of Participants With Adverse Events [ Time Frame: Baseline through the end of study (approximately 52 months) ]


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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed gastric cancer or adenocarcinoma of GEJ
  • HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed by local review based on pretreatment endoscopic biopsies.
  • Clinical stage at presentation: cT3/T4a/T4b, or N+, M0 as determined by AJCC staging system, 8th edition
  • Availability of pretreatment tumor specimen for biomarker analysis by central lab
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy >= 12 weeks
  • Adequate hematologic and end-organ function
  • For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception during the treatment period and to continue its use for at least i) 5 months after the last dose of atezolizumab, ii) 7 months after the last dose of trastuzumab, or iii) 6 months after the last dose of capecitabine or oxaliplatin, whichever is longer.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Stage IV (metastatic) or unresectable gastric/GEJ cancer determined by investigators
  • Prior systemic therapy for treatment of gastric cancer
  • History of malignancy other than GC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Cardiopulmonary dysfunction
  • Dyspnea at rest
  • Active or history of autoimmune disease or immune deficiency with the following exceptions: (a) Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid-replacement hormone are eligible for the study. (b) Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. (c) Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided allof following conditions are met: (i) Rash must cover < 10% of body surface area (ii) Disease is well controlled at baseline and requires only low-potency topical corticosteroids (iii) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Active tuberculosis
  • Patients with active hepatitis B
  • Patients with active hepatitis C

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): NCT04661150


Contacts
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Contact: Reference Study ID Number: ML42058 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
West China Hospital, Sichuan University; Department of Breast Recruiting
Chengdu, China, 610041
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, China, 510515
Sir Run Run Shaw Hospital Recruiting
Hangzhou, China, 310016
Harbin Medical University Cancer Hospital Recruiting
Harbin, China, 150081
Fudan University Shanghai Cancer Center; Medical Oncology Recruiting
Shanghai City, China, 201315
Zhongshan Hospital Fudan University Recruiting
Shanghai, China, 200032
Liaoning Provincial Cancer Hospital Recruiting
Shengyang, China, 110042
First Hospital of China Medical University; Surgery Recruiting
Shenyang City, China, 110001
Tianjin Medical University Cancer Institute & Hospital Recruiting
Tianjing, China, 300060
Zhejiang Cancer Hospital Recruiting
Zhejiang, China, 310022
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04661150    
Other Study ID Numbers: ML42058
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Trastuzumab
Atezolizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological