Study on Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT07383441
This clinical trial is exploring whether adding a live biotherapy called MO-03 to standard immunotherapy treatments can improve outcomes for patients with advanced kidney cancer. The study will compare the effects of MO-03 with a placebo when combined with standard treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
This study aims to find out if adding a live biotherapy, MO-03, to standard immunotherapy treatments can help treat advanced kidney cancer more effectively. The standard treatments include drugs like ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, which help the immune system attack cancer cells and prevent them from growing. MO-03 is believed to support gut health, which may enhance the effectiveness of these treatments. The study will compare the effects of MO-03 with a placebo to see which is more effective in treating advanced or metastatic kidney cancer.
Description
The main goal of this study is to see if adding MO-03 to standard immunotherapy can help patients with advanced kidney cancer live longer without the disease getting worse. The study will also look at the safety of MO-03 when combined with different standard treatments for kidney cancer. Researchers will compare how well the cancer responds to treatment, how long patients live, and any side effects between those receiving MO-03 and those receiving a placebo.
Participants will be randomly assigned to one of two groups. One group will receive MO-03 along with standard immunotherapy, while the other group will receive a placebo with standard immunotherapy. The treatments will be given in cycles, with each cycle lasting 42 days, and can continue for up to 3 years if the cancer does not progress and side effects are manageable.
Standard treatments include combinations of drugs like ipilimumab and nivolumab, axitinib and pembrolizumab, cabozantinib and nivolumab, or lenvatinib and pembrolizumab. These drugs are given either orally or through an IV, depending on the specific regimen.
Throughout the study, participants will undergo regular scans and blood tests to monitor their health and the cancer's response to treatment. After completing the study treatment, participants will have follow-up visits every 6 months for the first 2 years, then once a year for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Must have advanced or metastatic kidney cancer with a clear cell component.
- Cancer must be measurable by standard criteria.
- Must not require immediate treatment for brain metastases.
- Cannot be enrolled in other treatment studies while participating in this study.
- Must not take over-the-counter probiotic supplements during the study.
- Must not have had prior systemic therapy for advanced kidney cancer.
- Must not be on high doses of steroids or have taken antibiotics recently.
- Must be 18 years or older.
- Must have a good performance status and be able to take standard treatments.
- Must be able to swallow pills and have no digestive issues affecting absorption.
- Must have acceptable blood and organ function test results.
- Must not have uncontrolled high blood pressure or other serious health issues.
- Must not have autoimmune diseases that prevent immune therapy use.
- Must not be pregnant or nursing and must agree to use effective contraception.
- Must be willing to participate in specimen banking and complete questionnaires if applicable.
- Must provide informed consent to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group - Fayetteville | 72703 | Fayetteville | Arkansas |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Illinois CancerCare-Bloomington | 61704 | Bloomington | Illinois |
| Illinois CancerCare-Canton | 61520 | Canton | Illinois |
| Illinois CancerCare-Carthage | 62321 | Carthage | Illinois |
| Cancer Care Specialists of Illinois - Decatur | 62526 | Decatur | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| Illinois CancerCare-Eureka | 61530 | Eureka | Illinois |
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