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New treatment option for Bile Duct Cancer
Official title Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
ClinicalTrials.gov ID: NCT05000294
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bile duct cancer.
Also referred to as Tecentriq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- people must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has...
- An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal...
- people must not have more than one malignancy at the time of enrollment
- Adult people ≥ eighteen years of age
- A clinical diagnosis consistent with stage IV "immunogenically cold" or otherwise incurable cancer of one of the following histologies: i) bile duct...
You likely can't join if
- people with known MSI-H or dMMR tumor status
- people with severe uncontrolled hypertension as defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg
- people who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
- Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and...
- Females who are pregnant or breastfeeding
- History of leptomeningeal disease
See the full eligibility criteria
Who can join
- people must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart...
- An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.
- people must not have more than one malignancy at the time of enrollment
- Adult people ≥ eighteen years of age
- A clinical diagnosis consistent with stage IV "immunogenically cold" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative...
- Adequate hematologic and end-organ function
- people receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative HIV test at screening with the following exceptions: people with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have...
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \<1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of...
- Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study...
- Measurable disease by RECIST criteria
- A life expectancy of ≥ 12 weeks
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
- Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.
- If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease
- Subject must be able to swallow capsules
What rules you out
- people with known MSI-H or dMMR tumor status
- people with severe uncontrolled hypertension as defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg
- people who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
- Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug
- Females who are pregnant or breastfeeding
- History of leptomeningeal disease
- Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more...
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- people with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- people with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- people with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., people with psoriatic arthritis are excluded) are eligible for the study provided all of following...
- Rash must cover \<10% of body surface area
- Disease is well controlled at baseline and requires only lowpotency topical corticosteroids
- There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Active tuberculosis
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment...
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g...
- Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could...
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: people receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive...
- Prior allogeneic stem cell or solid organ transplantation
- Current treatment with anti-viral therapy for hepatitis B virus (HBV)
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following...
- people who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the...
- people who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or...
- Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detained for treatment of either a psychiatric or physical illness.
- people with Tumor Mutation Burden (TMB) ≥10
- Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start
- people with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. people with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30...
- people with autoimmune diseases requiring current treatment and people with history of severe autoimmune diseases, people with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy...
- Inability to discontinue use of medications contraindicated by the study treatment
- Proteinuria \> 2.5 g/24 hours or 3+ with urine dipstick
- QTc interval \> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.