PD-L1-selected Solid TumorsPhase 2SKYSCRAPER-11NCT05661578
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
A Phase 2 study testing Tiragolumab and Atezolizumab IV FDC in people with PD-L1-selected Solid Tumors, run by Hoffmann-La Roche at 32 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD-L1-selected Solid Tumors
- What is being tested?
- Tiragolumab and Atezolizumab IV FDC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 4 May 2023to 26 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
Spain9 sites
Hospital del Mar
Barcelona, 08003
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 8035
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
ICO l?Hospitalet ? Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, 28040
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
Madrid, 28050
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, 29010
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Clinico Universitario de Valencia
Valencia, 46010
Turkey (Türkiye)7 sites
Namik Kemal University
Alt?nova, 59100
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
Gazi University Medical Faculty
Ankara, 06500
Memorial Ankara Hastanesi
Ankara, 06520
Memorial Sisli Private Hospital
Istanbul, 34385
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, 44280
Medical Park Seyhan Hospital
Seyhan, 01060
Taiwan4 sites
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 70457
National Taiwan University Hospital
Taipei, 10002
TAIPEI VETERANS GENERAL HOSPITAL, Urology
Taipei, 11217
Greece3 sites
IASO Obstetrics Gynecology Clinic
Marousi, 151 23
University General Hospital of Patras
Pátrai, 265 00
St. Luke's Hospital
Thessaloniki, 552 36
South Korea3 sites
National Cancer Center
Goyang-si, 10408
Seoul National University Bundang Hospital
Seongnam-si, 13605
Asan Medical Center - PPDS
Seoul, 05505
Croatia2 sites
General Hospital Pula
Pula, 52000
Klinicki bolnicki centar Zagreb
Zagreb, 10000
Serbia2 sites
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
Oncology Institute of Vojvodina
Kamenitz, 21204
United States1 site
Medical Oncology Associates
Spokane, Washington, 99208
About this study
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
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.
- Conditions
- PD-L1-selected Solid Tumors
- Being tested
- Tiragolumab and Atezolizumab IV FDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiragolumab and Atezolizumab IV FDCDrug
Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Tiragolumab and Atezolizumab IV FDC | Experimental | 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. Receives: Drug: Tiragolumab and Atezolizumab IV FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
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.
Measured: Up to approximately 30.5 months
Secondary outcomes (12)
Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1
day*µg/mL=day-micrograms per milliliter.
Measured: Up to Day 21 of Cycle 1 (1 cycle=21 days)
Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
AUC0-21d of Atezolizumab at Cycle 1
Measured: Up to Day 21 of Cycle 1 (1 cycle=21 days)
AUC0-inf of Atezolizumab at Cycle 1
Measured: 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days)
Maximum Concentration (Cmax) of Tiragolumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Cmax of Atezolizumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Minimum Concentration (Cmin) of Tiragolumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Cmin of Atezolizumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Total Body Clearance (CL) of Tiragolumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
CL of Atezolizumab at Cycle 1
Measured: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
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.
Measured: Up to approximately 14.9 months
Number of Participants With ADAs to Atezolizumab
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.
Measured: Up to approximately 14.9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start4 May 2023
- Primary completion26 Dec 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PD-L1-selected Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661578
- Sponsor's protocol ID
- GO44096
- Other IDs
- 2022-001157-23, 2023-508489-14-00, 2023
- Acronym
- SKYSCRAPER-11
- Status last verified
- May 2026
- First submitted
- 15 Dec 2022
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05661578
- Acronym / sponsor ID
- SKYSCRAPER-11 / GO44096
- Conditions
- PD-L1-selected Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Posted 18 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tiragolumab and Atezolizumab IV FDC | Experimental | Drug: Tiragolumab and Atezolizumab IV FDCParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiragolumab and Atezolizumab IV FDCIntravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W). | Drug | Tiragolumab and Atezolizumab IV FDC |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 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.
12 secondary outcomes
Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1
Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)
Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
AUC0-21d of Atezolizumab at Cycle 1
Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)
AUC0-inf of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days)
Maximum Concentration (Cmax) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Cmax of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Minimum Concentration (Cmin) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Cmin of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Total Body Clearance (CL) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
CL of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Time frame: Up to approximately 14.9 months
Number of Participants With ADAs to Atezolizumab
Time frame: Up to approximately 14.9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiragolumab and Atezolizumab IV FDC in people with PD-L1-selected Solid Tumors, run by Hoffmann-La Roche at 32 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Turkey (Türkiye), Taiwan, Greece, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to approximately 30.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.