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
Characterization of the microbial resistome in a prospective trial of CBM588 in metastatic renal cell carcinoma (mRCC) offers mechanism for interplay between antibiotic (abx) use and immune checkpoint inhibitor (ICI) activity.
Dizman N, Meza L, Bergerot P, Dorff T, Lyou Y, Frankel P, Llamas M, Hsu J, Zengin Z, Malhotra J, Govindarajan A, Castro D, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Highlander S, Pal S. Characterization of the microbial resistome in a prospective trial of CBM588 in metastatic renal cell carcinoma (mRCC) offers mechanism for interplay between antibiotic (abx) use and immune checkpoint inhibitor (ICI) activity. Journal Of Clinical Oncology 2022, 40: 4510-4510. DOI: 10.1200/jco.2022.40.16_suppl.4510.Peer-Reviewed Original ResearchNivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial
Dizman N, Meza L, Bergerot P, Alcantara M, Dorff T, Lyou Y, Frankel P, Cui Y, Mira V, Llamas M, Hsu J, Zengin Z, Salgia N, Salgia S, Malhotra J, Chawla N, Chehrazi-Raffle A, Muddasani R, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Kortylewski M, Highlander SK, Pal SK. Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nature Medicine 2022, 28: 704-712. PMID: 35228755, PMCID: PMC9018425, DOI: 10.1038/s41591-022-01694-6.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaProgression-free survivalRenal cell carcinomaCell carcinomaCheckpoint inhibitorsResponse rateGut microbiomePoor-risk diseaseTreatment-naive patientsSingle-center studyPhase 1 trialRandomized phase 1 trialSignificant differencesBifidobacterium sppMechanism of actionNivolumab-ipilimumabSarcomatoid histologyPrimary endpointSecondary endpointsImmune compartmentStudy armsClinical outcomesClear cellsClinical observationsPatients