Study on Neoadjuvant HIF-Inhibitor Immunotherapy for Kidney Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07397611

Provider View

This clinical trial is testing the safety and effectiveness of the drug casdatifan, alone or with zimberelimab, in patients with clear cell renal cell carcinoma (ccRCC) that can be surgically removed.

Patient Parameters

Program Overview

The study aims to find out if the drug casdatifan, either by itself or combined with zimberelimab, is safe and effective for treating clear cell renal cell carcinoma (ccRCC) that can be surgically removed. Casdatifan is a HIF-2α inhibitor, and zimberelimab is a monoclonal antibody. The trial involves various tests and procedures, including blood tests, scans, and in-clinic visits. About 32 participants are expected to join this study, which is supported by Arcus Biosciences, Inc.

Description

This study involves two groups of participants with clear cell renal cell carcinoma (ccRCC) that can be surgically removed. Participants will be randomly assigned to one of two groups: one receiving casdatifan alone and the other receiving casdatifan with zimberelimab. Random assignment means participants are placed into groups by chance, like flipping a coin.

The study will include screening for eligibility, in-clinic visits, blood and urine tests, and imaging scans like CT, MRI, or PET scans. The U.S. Food and Drug Administration (FDA) has not yet approved casdatifan or zimberelimab for treating ccRCC.

Arcus Biosciences, Inc. is providing the study drugs for this research. The trial will involve about 32 participants.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Confirmed diagnosis of clear cell renal cell carcinoma (ccRCC) through a biopsy.
  • Specific stages of kidney cancer that require surgery.
  • Must have a measurable tumor that can be accurately measured by scans.
  • Planned for surgical removal of the kidney tumor.
  • Good overall health with an ECOG performance status of 0-1.
  • Adequate organ and bone marrow function based on specific lab tests.
  • No significant drop in blood oxygen levels during a 6-minute walk test.
  • No active lung inflammation or severe lung disease.
  • Normal heart function as shown by an echocardiogram or MUGA scan.
  • Negative pregnancy test for women of childbearing potential.
  • Agree to use effective contraception during and after the study.
  • Ability to understand and sign a consent form.
  • Ability to swallow tablets.

Exclusion Criteria

  • Previous systemic therapy for kidney cancer.
  • Recent radiation therapy within 4 weeks before starting the study.
  • Evidence of cancer spread to distant parts of the body.
  • Active lung inflammation or concern for lung disease.
  • Use of complementary medicines to treat the cancer within 2 weeks before starting the study.
  • Other active cancers within the past year, except for certain curable cancers.
  • Heart rhythm issues or recent major heart events.
  • Significant uncontrolled medical conditions.
  • Active infections requiring treatment.
  • Recent major surgery or incomplete healing from surgery.
  • Use of certain medications that affect the liver enzyme CYP3A4.
  • History of psychiatric or substance use disorders that may interfere with the study.
  • Recent use of live vaccines.
  • Current breastfeeding.
  • Known allergy to study drugs.
  • Use of supplemental oxygen therapy.
  • Any other condition that may compromise safety or study completion.

Locations

FACILITYZIPCITYSTATE
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Brigham and Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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