Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

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 5, 2026

Status verified

Jun 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 ]

Locations (41)

Find similar trials in Fayetteville, AR

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