2024
72 Impact of microbiome modulation on serum cytokine profile in a randomized, phase I trial of cabozantinib/nivolumab (cabo/nivo) with or without CBM588 in pts with metastatic renal cell carcinoma (mRCC)
Li Y, Ebrahimi H, Meza L, Malhotra J, Li X, Dizman N, Dorff T, Frankel P, Llamas-Quitiquit M, Hsu J, Zengin Z, Alcantara M, Castro D, Mercier B, Chawla N, Chehrazi-Raffle A, Barragan-Carrillo R, Gillece J, Trent J, Lee P, Parks T, Takahashi M, Hayashi A, Caporaso J, Lee K, Tripathi A, Pal S. 72 Impact of microbiome modulation on serum cytokine profile in a randomized, phase I trial of cabozantinib/nivolumab (cabo/nivo) with or without CBM588 in pts with metastatic renal cell carcinoma (mRCC). The Oncologist 2024, 29: s36-s37. PMCID: PMC11301871, DOI: 10.1093/oncolo/oyae181.059.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaSerum cytokine profilesCytokine profileClinical outcomesCD8-positive subsetGranulocyte-macrophage colony stimulating factorLevels of IL-12Poor-risk diseasePhase I trialRenal cell carcinomaCirculating cytokine levelsWilcoxon matched-pairs testLevels of cytokinesColony stimulating factorFlow cytometric analysisMatched-pairs testSarcomatoid histologySarcomatoid featuresSystemic immunomodulationCell carcinomaI trialClear cellCytokine levelsInterferon-gIL-13
2022
A phase I trial to evaluate the biologic effect of CBM588 (Clostridium butyricum) in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC).
Meza L, Malhotra J, Zengin Z, Dizman N, Hsu J, Chawla N, Chehrazi-Raffle A, Muddasani R, Govindarajan A, Castro D, Dorff T, Lyou Y, Frankel P, Pal S. A phase I trial to evaluate the biologic effect of CBM588 (Clostridium butyricum) in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2022, 40: tps4606-tps4606. DOI: 10.1200/jco.2022.40.16_suppl.tps4606.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaClinical responseClear cell metastatic renal cell carcinomaTyrosine kinase inhibitor cabozantinibBiologic effectsGut microbiomeImmune checkpoint inhibitor nivolumabOne-sided type I errorPhase I clinical trialFirst-line treatmentProgression-free survivalStudy's primary endpointCheckpoint inhibitor nivolumabPhase I trialPhase 1 trialSubgroup of patientsWeeks of treatmentCytokines/chemokinesDose/scheduleOngoing phase IRenal cell carcinomaImproved clinical benefitBifidobacterium sppEligible patientsPo bid