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A clinical trial to test the safety of tiragolumab and atezolizumab when combined and given from a single bottle, and to understand the way the body processes these drugs in people with cancer that has advanced in nearby cells (locally advanced), has come back (recurring), or that has spread to other parts of the body (metastatic)
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
- PD-L1-selected Solid Tumors
Trial Status:
Recruiting
This trial runs in
Countries
- South Korea
- United States
Trial Identifier:
NCT05661578 2022-001157-23 GO44096
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 investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05661578 , GO44096 , 2022-001157-23
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
1. Why is the SKYSCRAPER-11 clinical trial needed?
Cancer can be difficult to treat if it spreads to other organs in the body. However new medicines, such as cancer immunotherapies, have shown encouraging results for the treatment of cancer.
Cancer immunotherapies, such as tiragolumab and atezolizumab, use the body’s own immune system to destroy cancerous cells. However, this is the first time that the combination of tiragolumab and atezolizumab in one bottle will be administered to patients. This combination is being explored to try and simplify the administration of the two drugs and reduce the time that patients spend in the clinic.
This trial will look at the side effects (unexpected medical problems that occur while on treatment) that people may experience after being given the treatment of tiragolumab and atezolizumab combined into one bottle.
2. How does the SKYSCRAPER-11 clinical trial work?
This clinical trial is recruiting people who have cancer that has advanced in nearby cells (locally advanced), has come back (recurring), or that has spread to other parts of the body (metastatic).
The purpose of this clinical trial is to test the safety and effects (good or bad) of tiragolumab in combination with atezolizumab, as well as understand the way the body processes these drugs in people with cancer that has advanced in nearby cells (locally advanced), has come back (recurring), or that has spread to other parts of the body (metastatic). Participants who take part in this clinical trial will receive tiragolumab plus atezolizumab.
Participants will be given the clinical trial treatment tiragolumab plus atezolizumab until their cancer gets worse or they have unacceptable side effects. Participants will be seen by the clinical trial doctor every 3 weeks. These hospital visits will include checks to see how the participants are responding to the treatment and any side effects they may be having. After the participants have completed or stopped treatment, the clinical trial doctor will ask them to visit the hospital or clinic for a follow-up examination within 30 days after the final dose of clinical trial treatment.
The clinical trial doctor will continue to check in with the participants through telephone calls, clinic visits or medical records roughly every 3 months, for as long as they agree to it.
Participants’ total time in the clinical trial will depend on how their cancer responds to treatment. This could range from 1 day to more than 4 months. Participants are free to stop trial treatment and leave the clinical trial at any time.
3. What are the main endpoints of the SKYSCRAPER-11 clinical trial?
The main clinical trial endpoint (the main result that is measured in the trial to see if the medicine has worked) is to assess the number and seriousness of any side effects.
The other clinical trial endpoints include to understand the way the body processes tiragolumab and atezolizumab when given together from a single bottle, and how the body responds to these medicines.
4. Who can take part in this clinical trial?
People can take part in this trial if they are at least 18 years old and have been diagnosed with either locally advanced, recurring, or metastatic cancer that is positive for a protein known as PD-L1. Participants should also be willing to allow a tumour sample to be taken to see if their tumour is positive for PD-L1.
People may not be able to take part in this trial if they have certain other medical conditions such as heart and liver disease, have previously received certain treatments including but not limited to checkpoint inhibitor therapies (for example, anti-PD-L1/PD-1), are/planning to become pregnant, or are breastfeeding.
5. What treatment will participants be given in this clinical trial?
This is an open-label trial, which means everyone involved, including the participants and the doctors, know which medicine is being used. Everyone who joins this clinical trial will be given:
● Tiragolumab plus atezolizumab, as an injection into a vein (intravenous) every 3 weeks
The dose of tiragolumab and atezolizumab will be the same for all participants, meaning it will not vary based on weight or other factors.
6. Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to participants, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.
Risks associated with the clinical trial drugs
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe and even life-threatening and can vary from person to person.
Tiragolumab and atezolizumab
Potential participants will be told about the known side effects of tiragolumab and atezolizumab, and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs.
Tiragolumab and atezolizumab will be given as an injection into a vein (intravenous). Participants will be told about any known side effects of intravenous injections.
Potential benefits associated with the clinical trial
Participants' health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.
For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT05661578
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 investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05661578 , GO44096 , 2022-001157-23
Trial Identifier
Tiragolumab and Atezolizumab IV FDC
Treatments
PD-L1-selected Solid Tumors
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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 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
For the latest version of this information please go to www.forpatients.roche.com