Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer (NCT07383441)
Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]
๐ฉบ Plain-English Summary (8th-Grade Level)
This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group - Fayetteville โ Fayetteville, Arkansas
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- Highlands Oncology Group - Fayetteville โ Fayetteville, Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro โ Jonesboro, Arkansas
- Highlands Oncology Group - Rogers โ Rogers, Arkansas
- Highlands Oncology Group โ Springdale, Arkansas
- Illinois CancerCare-Bloomington โ Bloomington, Illinois
- Illinois CancerCare-Canton โ Canton, Illinois
- Illinois CancerCare-Carthage โ Carthage, Illinois
- Cancer Care Specialists of Illinois - Decatur โ Decatur, Illinois
- Decatur Memorial Hospital โ Decatur, Illinois
- Illinois CancerCare-Eureka โ Eureka, Illinois
- Illinois CancerCare-Galesburg โ Galesburg, Illinois
- Illinois CancerCare-Kewanee Clinic โ Kewanee, Illinois
- Illinois CancerCare-Macomb โ Macomb, Illinois
- Illinois CancerCare-Ottawa Clinic โ Ottawa, Illinois
- Illinois CancerCare-Pekin โ Pekin, Illinois
- Illinois CancerCare-Peoria โ Peoria, Illinois
- Illinois CancerCare-Peru โ Peru, Illinois
- Illinois CancerCare-Princeton โ Princeton, Illinois
- Southern Illinois University School of Medicine โ Springfield, Illinois
- Illinois CancerCare - Washington โ Washington, Illinois
- Mercy Hospital โ Cedar Rapids, Iowa
- Oncology Associates at Mercy Medical Center โ Cedar Rapids, Iowa
- Lahey Hospital and Medical Center โ Burlington, Massachusetts
- Lahey Medical Center-Peabody โ Peabody, Massachusetts
- Trinity Health IHA Medical Group Hematology Oncology - Brighton โ Brighton, Michigan
๐ Contact the Study Coordinator
Phone: (479) 872-8100
Email: research@hogonc.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Clear Cell Renal Cell Carcinoma
- CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer โ Duarte, California
- Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer โ Tampa, Florida
- RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy โ Duarte, California
- VSV-IFNฮฒ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma โ Rochester, Minnesota
- Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer โ Duarte, California
- Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study โ Duarte, California
Explore by condition: All Advanced Clear Cell Renal Cell Carcinoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.