Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

Sponsor
SWOG Cancer Research Network
Study ID
NCT07383441
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axitinib — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Cabozantinib — DRUG
    Given PO
  • Clostridium butyricum CBM 588 Probiotic Strain — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Lenvatinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV
  • Nivolumab and Recombinant Human Hyaluronidase — DRUG
    Given SC
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Placebo Administration — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 10, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2033
Completion
Jan 31, 2034

Study Design

Enrollment
718 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (MO-03, SOC immunotherapy)
    See Detailed Description
  • Placebo Comparator: Arm 2 (placebo, SOC immunotherapy)
    See Detailed Description

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 5 years ]

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