Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer

Description

PRIMARY OBJECTIVE:

I. To evaluate the effects of Faecalibacterium prausnitzii-containing bacterial strain formulation EXL01 (EXL01) (in combination with nivolumab/ipilimumab) on systemic immunomodulation in patients with mRCC.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of EXL01 (in combination with nivolumab/ipilimumab) in the treatment of patients with mRCC.

II. To evaluate the effect of EXL01 on the clinical efficacy of nivolumab/ipilimumab.

EXPLORATORY OBJECTIVES:

I. To determine the effect of EXL01 on gut microbiome diversity and function. II. To determine the effect of EXL01 on systemic immunodulation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:

CYCLES 1-4: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle and receive EXL01 orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle and EXL01 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo computed tomography (CT) and collection of blood samples throughout the study. Patients may undergo magnetic resonance imaging (MRI) at screening and may undergo bone scan as clinically indicated.

ARM B:

CYCLES 1-4: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo CT and collection of blood samples throughout the study. Patients may undergo MRI at screening and may undergo bone scan as clinically indicated.

After completion of study treatment, patients are followed up within 30 days then every 3 months for up to 2 years.