Study on Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for Treating Kidney Cancer After Surgery

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07037004

Provider View

This clinical trial is testing whether adding a special probiotic called CBM588 to the immunotherapy drug pembrolizumab can help prevent kidney cancer from coming back after surgery. Pembrolizumab is already used to treat kidney cancer by helping the immune system attack cancer cells. Researchers believe that CBM588 might improve the effectiveness of pembrolizumab by changing the bacteria in the body.

Patient Parameters

Program Overview

The purpose of this study is to see if adding a probiotic called CBM588 to the cancer treatment pembrolizumab can help stop kidney cancer from returning after surgery. Pembrolizumab is a type of immunotherapy that helps the immune system fight cancer. The study will compare the effects of pembrolizumab alone versus pembrolizumab with CBM588 to see if the combination is more effective in preventing cancer recurrence.

Description

The main goal of this study is to find out if the probiotic CBM588 can increase the production of a protein called interleukin-12, which may help the immune system fight cancer in patients with high-risk kidney cancer who have had surgery.

Other goals include:

  • Seeing if CBM588 can help patients live longer without the cancer coming back.
  • Checking if CBM588 can improve overall survival rates.
  • Studying changes in the bacteria in the gut and immune system markers in patients receiving pembrolizumab with or without CBM588.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take CBM588 by mouth twice a day and receive pembrolizumab through an IV every 21 or 42 days for up to a year, as long as the cancer does not progress or cause severe side effects. Blood samples and CT scans will be collected during the study.

  • Group 2: Will receive pembrolizumab through an IV every 21 or 42 days for up to a year, with the same conditions as Group 1. Blood samples and CT scans will also be collected.

After finishing the treatment, participants will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide informed consent.
  • Have a confirmed diagnosis of kidney cancer with specific characteristics.
  • Have a certain stage of cancer after surgery.
  • No previous immunotherapy for kidney cancer.
  • Be in good general health with a performance status of less than 2.
  • Be 18 years or older.
  • Any ethnicity or race.
  • Have good kidney and liver function based on specific blood tests.
  • Have adequate blood cell counts.
  • Women of childbearing potential and female partners of male participants must agree to use effective birth control during treatment and for at least 5 months after the last dose.

Exclusion Criteria

  • Previous radiation or certain immunotherapies for kidney cancer.
  • Active or recent autoimmune diseases requiring treatment with steroids or immunosuppressive drugs, except for certain conditions like vitiligo or type I diabetes.
  • Lung diseases requiring steroid treatment.
  • Low oxygen levels in the blood.
  • Use of probiotics or certain supplements within 2 weeks before starting treatment.
  • Conditions requiring steroid treatment within 14 days before starting the study drug.
  • Uncontrolled adrenal insufficiency.
  • Medical conditions that could increase risks or interfere with the study.
  • Not recovered from side effects of previous treatments.
  • Pregnant or breastfeeding women.
  • History of serious heart conditions or recent heart attack.

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