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NCT07383441 · ClinicalTrials.gov registry record · Phase 3
Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 718
- Enrollment target
NCT07383441: Recruiting Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT07383441 is a Phase 3 study that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 718 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07383441, a Phase 3 study, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 718 participants
- Enrollment target
Study Summary
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.
Primary Outcome
A Cox model will be used to test the treatment hazard ratio with stratification factors in the model as covariates for the futility and efficacy interim analyses and the final analysis.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Scan
- DRUG Cabozantinib
- DRUG Axitinib
- DRUG Clostridium butyricum CBM 588 Probiotic Strain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2026-06-05 |
| Est. Completion | 2034-01-31 |
| Phase | Phase 3 |
What NCT07383441 shows while recruiting
NCT07383441 is an interventional study that assigns participants to a tested intervention. The registered 718 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07383441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07383441 about?
NCT07383441 is a clinical study titled "Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer". 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 ...
What is the current status of trial NCT07383441?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 718 participants. The study started on 2026-06-05. Estimated completion is 2034-01-31.
What interventions are being tested in trial NCT07383441?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Scan (PROCEDURE), Cabozantinib (DRUG), Axitinib (DRUG), Clostridium butyricum CBM 588 Probiotic Strain (DRUG).
Who is sponsoring clinical trial NCT07383441?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07383441's enrollment target sits among peer trials
718 498th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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