PD-L1-selected Solid Tumors
Conditions
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.
Interventions
DRUGTiragolumab and Atezolizumab IV FDC
Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 30.5 months | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1 | Up to Day 21 of Cycle 1 (1 cycle=21 days) | day\*µg/mL=day-micrograms per milliliter. |
| Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| AUC0-21d of Atezolizumab at Cycle 1 | Up to Day 21 of Cycle 1 (1 cycle=21 days) | — |
| AUC0-inf of Atezolizumab at Cycle 1 | 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days) | — |
| Maximum Concentration (Cmax) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| Cmax of Atezolizumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| Minimum Concentration (Cmin) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| Cmin of Atezolizumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| Total Body Clearance (CL) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| CL of Atezolizumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) | — |
| Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab | Up to approximately 14.9 months | Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. |
| Number of Participants With ADAs to Atezolizumab | Up to approximately 14.9 months | Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. |
Countries
China, Croatia, Greece, Serbia, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 64 adult participants with histologically-confirmed programmed death-ligand 1 (PD-L1)-selected locally advanced, recurrent, or metastatic solid tumors, took part in the study at 27 investigative sites across 8 countries from 04 May 2023 to 26 December 2025.
Pre-assignment details
Participants received a fixed dose combination (FDC) of tiragolumab and atezolizumab. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 34 / 63 |
| other Total, other adverse events | 50 / 63 |
| serious Total, serious adverse events | 23 / 63 |
Outcome results
None listed