West Cancer Center

RENAL CELL: METASTATIC: 1st Line: BioFront Trial

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]

Title

SWOG S2419 Renal Cell microbiome

Study Title

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]

Site Link

NCT07383441

Malignancy

Renal cell cancer, kidney cancer, RCC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Clostridium butyricum CBM 588 Probiotic strain

Drug Class

Microbiome modulator

Brad Somer, MD

Sponsor

SWOG

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically confirmed RCC with clear cell component unresectable or metastatic
Measurable or evaluable disease. Bone scan only or pleural effusion only disease are considered evaluable
No active CNS mets
No over the counter probiotics
1st line
ECOG PS 0-2

Objective

PRimary
- PFS
Secondary
- OS
- 12 and 24 mo PFS
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Clear cell

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes