Study on Atezolizumab and Tivozanib for Treating Certain Hard-to-Treat Cancers

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05000294

Provider View

This clinical trial is exploring a new treatment combination of atezolizumab and tivozanib to see if it can help treat cancers that typically do not respond well to immunotherapy, such as prostate cancer and pancreatic cancer.

Patient Parameters

Program Overview

This study is testing a new combination of drugs, atezolizumab and tivozanib, to see if they can work together to treat certain cancers that are usually hard to treat with immunotherapy alone. These cancers include prostate cancer, biliary tract cancers, soft tissue sarcomas, and others. The study aims to find out if blocking a protein called VEGF can help the immune system better attack these cancers when combined with atezolizumab, an immune checkpoint inhibitor.

Eligibility Criteria

Inclusion Criteria

  • Must have had at least one previous treatment for advanced or metastatic cancer that cannot be removed by surgery.
  • Must be in relatively good health, with a performance status score of 1 or less for phase 1B, and 2 or less for phase 2.
  • Must not have more than one type of cancer at the time of joining the study.
  • Must be 18 years or older.
  • Must have a diagnosis of stage IV or incurable cancer from a specific list, including bile duct cancer, certain types of breast cancer, neuroendocrine cancer, ovarian cancer, pancreatic cancer, soft tissue sarcoma, prostate cancer, or vulvar cancer.
  • Must have good blood and organ function.
  • If on blood thinners, must be on a stable dose for at least 2 weeks before starting the study treatment.
  • Must test negative for hepatitis B and HIV, unless HIV is well-controlled.
  • Women who can become pregnant must use effective birth control during the study and for 160 days after the last dose.
  • Men with partners who can become pregnant must use effective birth control during the study and for 160 days after the last dose.
  • Must have measurable cancer by specific criteria.
  • Must have a life expectancy of at least 12 weeks.
  • Must agree to provide a tissue sample for research purposes.
  • Must be able to swallow capsules.

Exclusion Criteria

  • Cannot have tumors with certain genetic markers (MSI-H or dMMR).
  • Cannot have uncontrolled high blood pressure.
  • Cannot have had previous treatment with certain cancer drugs (VEGFR tyrosine kinase inhibitors).
  • Cannot be pregnant or breastfeeding.
  • Cannot have a history of certain diseases, like leptomeningeal disease or severe autoimmune diseases, unless well-controlled.
  • Cannot have active infections or significant heart disease.
  • Cannot have had major surgery within 4 weeks before starting the study.
  • Cannot have had another type of cancer within the last 5 years, except for certain low-risk cancers.
  • Cannot have had severe infections or be on certain medications that affect the immune system within a specified time before the study.
  • Cannot have had a stem cell or organ transplant.
  • Cannot have had certain treatments or vaccines within a specified time before the study.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot have any condition that might interfere with the study or increase the risk of complications.

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