2024
Impact of Latino ethnicity on the gut microbiome composition of patients with metastatic renal cell cancer (mRCC).
Barragán Carrillo R, Dizman N, Ebrahimi H, Meza L, Bergerot P, Dorff T, Hsu J, Zengin Z, Salgia N, Chehrazi-Raffle A, Tripathi A, Castro D, Mercier B, Caporaso G, Lee K, Pal S. Impact of Latino ethnicity on the gut microbiome composition of patients with metastatic renal cell cancer (mRCC). Journal Of Clinical Oncology 2024, 42: 4521-4521. DOI: 10.1200/jco.2024.42.16_suppl.4521.Peer-Reviewed Original ResearchMetastatic renal cell cancerImmune checkpoint inhibitionGut microbiome compositionBeta diversityBacterial speciesANCOM-BCAbundance of bacterial speciesWhole metagenome sequencingF/B ratioRatio of Firmicutes/BacteroidetesStool specimensShannon diversity indexR. inulinivoransE. rectaleRenal cell cancerTaxonomic profilesMetagenomic sequencingAlpha diversityGut microbiotaGut microbiomeMicrobiome compositionBray-CurtisDiversity indexComposition of patientsGut dysbiosis
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 bidNivolumab 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
2021
First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM-588 in patients with metastatic renal cell carcinoma.
Meza L, Dizman N, Bergerot P, Dorff T, Lyou Y, Frankel P, Mira V, Llamas M, Hsu J, Zengin Z, Salgia N, Salgia S, Malhotra J, Chawla N, Chehrazi-Raffle A, Gillece J, Reining L, Trent J, Highlander S, Pal S. First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM-588 in patients with metastatic renal cell carcinoma. Journal Of Clinical Oncology 2021, 39: 4513-4513. DOI: 10.1200/jco.2021.39.15_suppl.4513.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaProgression-free survivalNivolumab/ipilimumabRenal cell carcinomaCBM 588Response rateClinical outcomesWeek 12Cell carcinomaSarcomatoid Metastatic Renal Cell CarcinomaMedian progression-free survivalGut microbiomeGrade 3/4 toxicitiesPhase Ib studyKey eligibility criteriaDiagnosis of sarcomaIMDC criteriaEvaluable patientsPrimary endpointSecondary endpointsICI responseMetastatic diseaseSarcomatoid featuresIntermediate riskMedian age