Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types (NCT05000294) | Clinical Trial Compass
RecruitingPhase 1/2
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
United States29 participantsStarted 2021-12-07
Plain-language summary
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.
Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.
Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.
Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
. Subjects 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 study.
. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines atezolizumab, an immunotherapy drug, with tivozanib, a targeted therapy, specifically for tumors described as 'immunologically cold' — can you explain what that means for my specific cancer type, and whether my tumor would actually be considered 'cold' based on my pathology results?
2Since this is a Phase 1/Phase 2 trial, the combination of atezolizumab and tivozanib is still being studied for safety and effectiveness in these tumor types — what is currently known about the side effect profile of these two drugs together, and are there risks I should be especially aware of given my overall health?
3The trial covers several very different cancer types, from pancreatic adenocarcinoma to soft tissue sarcoma — does the treatment approach or dosing differ depending on which cancer type I have, or would I be treated the same way as patients with completely different diagnoses?
4The primary goal of this trial is to measure objective response rate, meaning whether tumors actually shrink — given where my cancer currently stands, is there a standard treatment option that already has a known response rate I could compare this trial against before deciding?
5My cancer type is listed among the eligible conditions, but how would you weigh the potential benefit of trying this experimental combination now versus pursuing other established therapies first, especially since this trial is still in an early phase?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.