Breast Cancer Clinical Trial

A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Summary

A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Gastric Cancer Cohorts Inclusion Criteria:

Age >/= 18 years;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Life expectancy >/= 3 months, as determined by the investigator;
Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma of gastric or gastroesophageal junction; (for the 1L Gastric Cancer Cohort: no prior systemic therapy for the locally advanced or metastatic disease; for the 2L Gastric Cancer Cohort: disease progression during or following a first-line platinum-containing or fluoropyrimidine-containing chemotherapy regimen);
Availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT levels by IHC and/or additional biomarker status by means of retrospective central testing;
Only for the 1L Gastric Cancer Cohort: human epidermal growth factor receptor 2 (HER2)-negative tumors;
Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1);
Adequate hematologic and end organ function based on laboratory results obtained within 14 days prior to initiation of study treatment;
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm;
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm.

Esophageal Cancer Cohort Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus in locally advanced or metastatic disease;
No prior systemic treatment for esophageal cancer, with the following exception:

For patients treated with chemotherapy in the locally advanced setting: occurrence of metastasis after 6 months from the last dose of chemotherapy;

For patients with adenocarcinoma: absence of HER2 expression;
Life expectancy >/=3 months as determined by the investigator;
Measurable disease per RECIST v1.1;
Adequate hematologic and end-organ function;
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs;
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm;
ECOG Performance Status of 0, 1, or 2.

Exclusion Criteria:

Exclusion criteria for the 2L Gastric Cancer Cohort:

Urinary protein is > 1 + on dipstick and the required following 24-hour urine collection shows urinary protein > 2000 mg;
Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to initiation of study treatment;
History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment;
Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea;
Uncontrolled arterial hypertension >/= 150/ >/= 90 millimeter of mercury (mmHg) despite standard medical management;
Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet agents.

Gastric Cancer Exclusion Criteria:

Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy;
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
History of leptomeningeal disease;
Active or history of autoimmune disease or immune deficiency;
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan;
Positive test for human immunodeficiency virus (HIV) at screening;
Active hepatitis B virus (HBV) or hepatitis C (HCV) infection;
Severe infection within 4 weeks prior to initiation of study treatment;
Significant cardiovascular disease;
Significant bleeding disorder;
Prior allogeneic stem cell or solid organ transplantation;
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;
Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar agents for therapeutic purposes;
History of malignancy other than gastric or gastroesophageal junction carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death;
Known allergy or hypersensitivity to any of the study drugs or their excipients.

Esophageal Cancer Cohort Exclusion Criteria:

High risk for developing esophageal fistula by clinical assessment or imaging;
Symptomatic, untreated, or actively progressing central nervous system (CNS) Metastases;
Positive EBV viral capsid antigen IgM test at screening;
History of leptomeningeal disease;
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 (CT) scan;
Active tuberculosis;
Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina;
History of malignancy other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death;
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

410

Study ID:

NCT03281369

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 41 Locations for this study

See Locations Near You

Mayo Clinic Cancer Center
Scottsdale Arizona, 85259, United States
Uni of Southern California; Norris Comprehensive Cancer Ctr
Los Angeles California, 90033, United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago Illinois, 60637, United States
University of Kentucky
Lexington Kentucky, 40536, United States
Dana-Farber Cancer Institute - Gastrointestinal Cancer Treatment Center
Boston Massachusetts, 02111, United States
Mayo Clinic - Rochester; Breast Cancer Center
Rochester Minnesota, 55905, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Froedtert and The Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Blacktown Hospital
Blacktown New South Wales, 2148, Australia
Monash Medical Centre-Moorabbin Campus
Clayton Victoria, 3168, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne Victoria, 3000, Australia
Gustave Roussy Cancer Campus
Villejuif , 94805, France
Universitätsklinikum Essen; Innere Klinik (Tumorforschung)
Essen , 45147, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt am Main , 60488, Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg , 69120, Germany
Ben-Gurion University of the Negev - Soroka University Medical Center
Beer Sheva , 84101, Israel
Rambam Health Care Campus; Oncology
Haifa , 31096, Israel
Hadassah University Medical Center
Jerusalem , , Israel
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva , 49414, Israel
Sourasky Medical Centre
Tel-Aviv , 64239, Israel
Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center; Cancer Metastasis Research Center
Seodaemun-Gu , 03722, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital (SNUH) - Medical Oncology Center
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu , 05505, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
Suwon-si, , 442-7, Korea, Republic of
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
Pamplona Navarra, 31008, Spain
Hospital Universitari Vall dHebron; Oncology
Barcelona , 08035, Spain
National Cheng Kung University Hospital
Tainan , 70457, Taiwan
Taipei Veterans General Hospital
Taipei City , 11217, Taiwan
National Taiwan University Hospital (NTUH) - Cancer Research Center
Zhongzheng Dist. , 10051, Taiwan
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM
London , 0, United Kingdom
The Royal Marsden
London , SW7 3, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

410

Study ID:

NCT03281369

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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