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Study identifier: NCT07383441 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

Condition: Advanced Clear Cell Renal Cell Carcinoma · Metastatic Clear Cell Renal Cell Carcinoma · Stage III Renal Cell Cancer AJCC v8  ·  Sponsor: SWOG Cancer Research Network

PhasePhase 3
Planned participants718
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (41)

Highlands Oncology Group - FayettevilleFayetteville, Arkansas, United StatesRecruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas, United StatesRecruiting
Highlands Oncology Group - RogersRogers, Arkansas, United StatesRecruiting
Highlands Oncology GroupSpringdale, Arkansas, United StatesRecruiting
Illinois CancerCare-BloomingtonBloomington, Illinois, United StatesRecruiting
Illinois CancerCare-CantonCanton, Illinois, United StatesRecruiting
Illinois CancerCare-CarthageCarthage, Illinois, United StatesRecruiting
Cancer Care Specialists of Illinois - DecaturDecatur, Illinois, United StatesRecruiting
Decatur Memorial HospitalDecatur, Illinois, United StatesRecruiting
Illinois CancerCare-EurekaEureka, Illinois, United StatesRecruiting
Illinois CancerCare-GalesburgGalesburg, Illinois, United StatesRecruiting
Illinois CancerCare-Kewanee ClinicKewanee, Illinois, United StatesRecruiting

+ 29 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07383441