Phase
Condition
Neoplasms
Treatment
Tiragolumab and Atezolizumab IV FDC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy >=12 weeks
Adequate hematologic and end organ function
Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities fromprevious therapy, excluding alopecia
For female participants of childbearing potential, negative serum pregnancy testwithin 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrainfrom donating eggs during the treatment period and for 5 months after the final doseof tiragolumab and atezolizumab IV FDC
For male participants: agreement to remain abstinent (refrain from heterosexualintercourse) or use a condom, and agree to refrain from donating sperm during thetreatment period and for 90 days after the final dose of tiragolumab andatezolizumab IV FDC to avoid exposing the embryo
Cancer-Specific Inclusion Criteria:
Histologic documentation of locally advanced, recurrent, or metastatic malignancy,ineligible for definitive local therapy, for which a clinical trial of aninvestigational agent in combination with an anti-PD-L1 antibody is considered anacceptable treatment option. Participant must be informed of all standard of careoptions available for his/her cancer.
No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Submittal of archival tumor and/or fresh tumor tissue to the central laboratory forprogrammed death-1 (PD-L1) evaluation prior to enrollment
PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263)immunohistochemistry (IHC) assay
Exclusion
Exclusion Criteria:
Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 5 months after the final dose of tiragolumab and atezolizumab IV FDC
Significant cardiovascular disease
Known clinically significant liver disease
Poorly controlled Type 2 diabetes mellitus
Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation ofneed for a major surgical procedure during the study
Any other diseases, metabolic dysfunction, physical examination finding, and/orclinical laboratory finding giving reasonable suspicion of a disease or conditionthat contraindicates the use of an investigational drug or that may affect theinterpretation of the results or may render the participant at high risk fromtreatment complications
History of autoimmune disease
Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1of Cycle 1
History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, orevidence of active pneumonitis on screening chest computed tomography (CT) scan
Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oralor IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
Cancer-Specific Exclusion Criteria:
Any anti-cancer therapy, whether investigational or approved within 3 weeks prior toinitiation of study treatment
Prior treatment with immune checkpoint inhibitors (CPIs)
Less than 5 drug-elimination half-lives (~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
Less than 6 weeks between the last dose of prior immunomodulators and the proposedDay 1 of Cycle 1
Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of priortreatment with cancer vaccines and/or cytokines have elapsed between the last doseand the proposed Cycle 1, Day 1
Any history of an immune-mediated Grade 4 adverse event attributed to prior cancerimmunotherapy
Any history of an immune-mediated Grade 3 adverse event attributed to prior cancerimmunotherapy that resulted in permanent discontinuation of the priorimmunotherapeutic agent and/or occurred </=6 months prior to Day 1 of Cycle 1
Any immune-mediated adverse events related to prior cancer immunotherapy must haveresolved completely to baseline
Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
Study Design
Connect with a study center
Princess Margaret Cancer Centre
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaSite Not Available
Chongqing Sanxia Central Hospital
Chongqing City, 404000
ChinaActive - Recruiting
Tianjin Cancer Hospital
Tianjin, 300060
ChinaActive - Recruiting
General Hospital Pula
Pula, 52000
CroatiaCompleted
Klinicki bolnicki centar Zagreb
Zagreb, 10000
CroatiaSite Not Available
German Oncology Center
Lemesos, 3096
CyprusSite Not Available
Bank Of Cyprus Oncology Centre
Strovolos, 2006
CyprusSite Not Available
Cancer Research Centre
Tbilisi, 0159
GeorgiaSite Not Available
LLC Todua Clinic
Tbilisi, 0112
GeorgiaSite Not Available
Ltd Israel-Georgia Medical Research Clinic Helsicore
Tbilisi, 0112
GeorgiaSite Not Available
University of Athens Medical School - Regional General Hospital Alexandra
Athens, 115 28
GreeceSite Not Available
University of Athens, Hematological Clinic,
Athens, 115 28
GreeceSite Not Available
University of Athens, Hematological Clinic,; First Department of Propaedeutic Medicine
Athens, 115 28
GreeceSite Not Available
IASO Obstetrics Gynecology Clinic
Marousi, 151 23
GreeceCompleted
Agios Loucas Clinic SA
Panorama, 552 36
GreeceSite Not Available
University General Hospital of Patras
Patras, 265 00
GreeceSite Not Available
Euromedica PPDS
Thessaloniki, 546 45
GreeceSite Not Available
Interbalkan Medical Center of Thessaloniki
Thessaloniki, 546 39
GreeceSite Not Available
National Cancer Center
Goyang-si, 10408
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13605
Korea, Republic ofSite Not Available
Asan Medical Center - PPDS
Seoul, 05505
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali, BAJA California 21200
MexicoSite Not Available
Health Pharma Professional Research
Cdmx, Mexico CITY (federal District) 03100
MexicoSite Not Available
Institute for Oncology and Radiology of Serbia
Belgrade, 11000
SerbiaSite Not Available
Oncomed-System
Belgrade, 11000
SerbiaSite Not Available
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
SerbiaSite Not Available
Health Center Kladovo
Kladovo, 19320
SerbiaSite Not Available
Institute of Lung Diseases Vojvodina
Sremska Kamenica, 21204
SerbiaSite Not Available
Oncology Institute of Vojvodina
Sremska Kamenica, 21204
SerbiaSite Not Available
ICO l?Hospitalet ? Hospital Duran i Reynals
L?Hospitalet De Llobregat, Barcelona 08908
SpainCompleted
Hospital Universitario Virgen Macarena
Seville, Sevilla 41071
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
C.H. Regional Reina Sofia - PPDS
Cordoba, 14004
SpainSite Not Available
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
Madrid, 28050
SpainCompleted
Hospital Regional Universitario de Malaga ? Hospital General
Malaga, 29010
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanCompleted
National Cheng Kung University Hospital
Tainan, 70457
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanCompleted
TAIPEI VETERANS GENERAL HOSPITAL, Urology
Taipei, 11217
TaiwanSite Not Available
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 1370
TurkeySite Not Available
Namik Kemal University
Alt?nova, 59100
TurkeySite Not Available
Ankara Bilkent City Hospital
Ankara, 06490
TurkeySite Not Available
Gazi University Medical Faculty
Ankara, 06500
TurkeySite Not Available
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
TurkeySite Not Available
Memorial Ankara Hastanesi
Ankara, 06520
TurkeySite Not Available
Memorial Sisli Private Hospital
Istanbul, 34385
TurkeySite Not Available
Memorial Sisli Private Hospital; Urology
Istanbul, 34385
TurkeySite Not Available
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722
TurkeySite Not Available
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, 44280
TurkeySite Not Available
Medical Park Seyhan Hospital
Seyhan, 01060
TurkeySite Not Available
Pikeville Medical Center
Pikeville, Kentucky 41501
United StatesSite Not Available
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesSite Not Available
The Center for Cancer and Blood Disorders - PPDS
Fort Worth, Texas 76104-4611
United StatesSite Not Available
Medical Oncology Associates
Spokane, Washington 99208
United StatesSite Not Available
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