A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
- Conditions
- PD-L1-selected Solid Tumors
- Interventions
- Registration Number
- NCT05661578
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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 from previous therapy, excluding alopecia
- For female participants of childbearing potential, negative serum pregnancy test within 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 refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab 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 an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options 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 for programmed death-1 (PD-L1) evaluation prior to enrollment
- PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 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 of need for a major surgical procedure during the study
- Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
- History of autoimmune disease
- Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence 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/oral or 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 to initiation 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 proposed Day 1 of Cycle 1
- Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
- Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
- Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred </=6 months prior to Day 1 of Cycle 1
- Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
- Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tiragolumab and Atezolizumab IV FDC Tiragolumab and Atezolizumab IV FDC Participants will receive tiragolumab and atezolizumab as an intravenous fixed dose combination (IV FDC) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to approximately 24 months
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12, 16 and treatment discontinuation (TD) visit (up to approximately 24 months) Cmax of Atezolizumab Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 Area Under the Concentration Time Curve (AUC) of Tiragolumab Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 AUC of Atezolizumab Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 Maximum Serum Concentration (Cmax) of Tiragolumab Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 Percentage of Participants With ADAs to Atezolizumab Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12, 16 and TD visit (up to approximately 24 months)
Trial Locations
- Locations (38)
Medical Oncology Associates
🇺🇸Spokane, Washington, United States
Chongqing Sanxia Central Hospital
🇨🇳Chongqing City, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
General Hospital Pula
🇭🇷Pula, Croatia
Klinicki bolnicki centar Zagreb
🇭🇷Zagreb, Croatia
German Oncology Center
🇨🇾Lemesos, Cyprus
Bank Of Cyprus Oncology Centre
🇨🇾Strovolos, Cyprus
IASO Obstetrics Gynecology Clinic
🇬🇷Marousi, Greece
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
🇪🇸Madrid, Spain
Agios Loucas Clinic SA
🇬🇷Panorama, Greece
University General Hospital of Patras
🇬🇷Patras, Greece
Interbalkan Medical Center of Thessaloniki
🇬🇷Thessaloniki, Greece
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Oncomed-System
🇷🇸Belgrade, Serbia
University Hospital Medical Center Bezanijska kosa
🇷🇸Belgrade, Serbia
Oncology Institute of Vojvodina
🇷🇸Sremska Kamenica, Serbia
ICO l?Hospitalet ? Hospital Duran i Reynals
🇪🇸L?Hospitalet De Llobregat, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
C.H. Regional Reina Sofia - PPDS
🇪🇸Cordoba, Spain
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga ? Hospital General
🇪🇸Malaga, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
TAIPEI VETERANS GENERAL HOSPITAL, Urology
🇨🇳Taipei, Taiwan
Namik Kemal University
🇹🇷Alt?nova, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Memorial Ankara Hastanesi
🇹🇷Ankara, Turkey
Memorial Sisli Private Hospital
🇹🇷Istanbul, Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center
🇹🇷Malatya, Turkey
Medical Park Seyhan Hospital
🇹🇷Seyhan, Turkey