Clinical trial NCT05661578: 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
Official title: A Phase II, Single-Arm, Open-Label Study Evaluating 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: PD-L1-selected Solid Tumors
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Area Under the Concentration Time Curve (AUC) of Tiragolumab
timeFrame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15
measure: AUC of Atezolizumab
timeFrame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15
measure: Maximum Serum Concentration (Cmax) of Tiragolumab
timeFrame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15
measure: Cmax of Atezolizumab
timeFrame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
timeFrame: 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)
measure: Percentage of Participants With ADAs to Atezolizumab
timeFrame: Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12, 16 and TD visit (up to approximately 24 months)
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Chongqing City
country: China
facility: Chongqing Sanxia Central Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Pula
country: Croatia
facility: General Hospital Pula
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb
city: Lemesos
country: Cyprus
facility: German Oncology Center
city: Strovolos
country: Cyprus
facility: Bank Of Cyprus Oncology Centre
city: Marousi
country: Greece
facility: IASO Obstetrics Gynecology Clinic
city: Panorama
country: Greece
facility: Agios Loucas Clinic SA
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Belgrade
country: Serbia
facility: Oncomed-System
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: L?Hospitalet De Llobregat
country: Spain
facility: ICO l?Hospitalet ? Hospital Duran i Reynals
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
city: Madrid
country: Spain
facility: START MADRID_Hospital Universiario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga ? Hospital General
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology
city: Alt?nova
country: Turkey
facility: Namik Kemal University
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Istanbul
country: Turkey
facility: Memorial Sisli Private Hospital
city: Malatya
country: Turkey
facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center
city: Seyhan
country: Turkey
facility: Medical Park Seyhan Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: