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NCT05000294 · ClinicalTrials.gov registry record · Phase 1
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
A Phase 1 study, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT05000294: Recruiting Phase 1 study, sponsored by University of Florida.
NCT05000294 is a Phase 1 study that is actively recruiting participants, run by University of Florida. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05000294, a Phase 1 study, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
To determine the best overall response rate (ORR) of atezolizumab plus tivozanib in subjects with immunologically cold tumors
Interventions
- DRUG Atezolizumab
- DRUG Tivozanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT05000294 shows while recruiting
NCT05000294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT05000294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05000294 about?
NCT05000294 is a clinical study titled "Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types". 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 no...
What is the current status of trial NCT05000294?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2021-12-07. Estimated completion is 2027-06.
What interventions are being tested in trial NCT05000294?
The interventions under investigation include: Atezolizumab (DRUG), Tivozanib (DRUG).
Who is sponsoring clinical trial NCT05000294?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05000294's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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