Study on Pembrolizumab and Axitinib Before Surgery for Kidney Cancer with Tumor in the Main Vein

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05969496

Provider View

This clinical trial is testing whether a combination of two drugs, Pembrolizumab and Axitinib, given before surgery, can reduce the size of a tumor in the main vein (Inferior Vena Cava) in patients with kidney cancer. The goal is to see if this can make surgery safer and improve long-term health outcomes.

Patient Parameters

Program Overview

The main aim of this study is to find out if using Pembrolizumab and Axitinib together before surgery can shrink the tumor in the main vein (Inferior Vena Cava) in patients with kidney cancer. A smaller tumor could lead to fewer surgical complications, better health outcomes for patients, and improved long-term results like longer survival without the cancer getting worse.

Description

Participants in this study will take Axitinib pills twice a day, starting at 5 mg and possibly increasing to 7 mg or 10 mg if tolerated. They will also receive Pembrolizumab through an IV every 21 days. This treatment will last for 12 weeks, which is 4 cycles. After the treatment, a scan will be done to check the tumor's response. Surgery will be scheduled within two weeks after the last scan.

During the study, patients will fill out questionnaires about their health and well-being related to kidney cancer. These will be given during study visits while receiving the treatment before surgery.

Eligibility Criteria

Inclusion Criteria

  • Must be able to sign and date a consent form.
  • Willing to follow all study procedures and be available for the study duration.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of kidney cancer with a clear cell component.
  • Must be a candidate for surgery according to the treating urologist.
  • Must be suitable and willing to undergo kidney surgery.
  • Must have a specific stage of cancer (cT3b, cT3c, cT4) and specific lymph node and metastasis stages (cN0 or cN1, cM0 or cM1).
  • Must have an ECOG performance status of 0 to 2.
  • Must have less than 2+ protein in urine. If 2+ or more, a 24-hour urine test must show less than 2g of protein.
  • Women of childbearing potential must have a negative pregnancy test within 14 days before starting treatment.
  • Must use effective birth control during treatment and for a period after treatment if of reproductive potential.

Exclusion Criteria

  • Currently in or recently participated in another study with an investigational drug or device.
  • Had major surgery within 4 weeks or radiation therapy within 1 week before joining the study.
  • Previously treated with certain immune therapies or VEGF/VEGFR therapies for kidney cancer.
  • History of severe allergic reactions to Axitinib.
  • Have an immune deficiency or are on high-dose steroids or other immunosuppressive treatments.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have another active cancer needing treatment in the last 3 years, except for certain skin or localized cancers.
  • Have active brain metastases or cancer in the brain lining.
  • Have a history of lung inflammation needing steroids.
  • Have liver enzymes (ALT or AST) more than 3 times the normal limit.
  • Received a live vaccine within 30 days before joining the study.
  • Have active gastrointestinal bleeding or conditions increasing the risk of bleeding.
  • Have a heart condition or high blood pressure not well controlled.
  • Have poor wound healing or active bleeding disorders.
  • Use certain medications affecting liver enzymes or heart rhythm.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Have had a solid organ transplant.
  • Are pregnant, breastfeeding, or planning to conceive during the study and for a period after.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.