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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 is a Phase 1 study that is actively recruiting participants, run by University of Florida. The registered enrollment target is 29 participants.

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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.

Interventions

  • DRUG Atezolizumab
  • DRUG Tivozanib

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2021-12-07
Est. Completion 2027-06
Phase Phase 1

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT05000294

The ClinicalTrials.gov registry entry for NCT05000294 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.

NCT05000294 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.