Trial record 1 of 1 for:
GO44096
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 (SKYSCRAPER-11)
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| ClinicalTrials.gov Identifier: NCT05661578 |
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Recruitment Status :
Recruiting
First Posted : December 22, 2022
Last Update Posted : April 12, 2024
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| PD-L1-selected Solid Tumors | Drug: Tiragolumab and Atezolizumab IV FDC | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 4, 2023 |
| Estimated Primary Completion Date : | February 14, 2025 |
| Estimated Study Completion Date : | February 14, 2025 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Tiragolumab and Atezolizumab IV FDC
Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W). |
Primary Outcome Measures :
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]
Secondary Outcome Measures :
- Area Under the Concentration Time Curve (AUC) of Tiragolumab [ Time Frame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 ]
- AUC of Atezolizumab [ Time Frame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 ]
- Maximum Serum Concentration (Cmax) of Tiragolumab [ Time Frame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 ]
- Cmax of Atezolizumab [ Time Frame: Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15 ]
- Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: 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) ]
- Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12, 16 and TD visit (up to approximately 24 months) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05661578
Contacts
| Contact: Reference Study ID Number: GO44096 https://forpatients.roche.com/ | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
Locations
Show 55 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT05661578 |
| Other Study ID Numbers: |
GO44096 2022-001157-23 ( EudraCT Number ) 2023-508489-14-00 ( Registry Identifier: EU CT ) |
| First Posted: | December 22, 2022 Key Record Dates |
| Last Update Posted: | April 12, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasms Atezolizumab Immune Checkpoint Inhibitors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents |