2022
Nivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: A randomized phase Ib study and the evolution of the functionality of microbial communities with treatment.
Dizman N, Meza L, Bergerot P, Alcantara M, Dorff T, Lyou Y, Frankel P, Llamas M, Hsu J, Zengin Z, Malhotra J, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Highlander S, Pal S. Nivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: A randomized phase Ib study and the evolution of the functionality of microbial communities with treatment. Journal Of Clinical Oncology 2022, 40: 371-371. DOI: 10.1200/jco.2022.40.6_suppl.371.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaNivolumab/ipilimumabRenal cell carcinomaClinical outcomesIpilimumab armCell carcinomaTissue next-generation sequencingPhase Ib studyProtocol-based therapyHigh-risk diseaseGut microbial compositionGut microbiome functionalityGut microbiome functionPrior nephrectomyObjective responseSarcomatoid featuresMedian ageRisk diseaseWeek 12Body of evidenceIpilimumabStool samplesClear cellsTreatment responseIb studyIntestinal microbiome associated with development of grade 3/4 adverse in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab (N/I) and probiotic support: Results from a phase Ib study.
Meza L, Dizman N, Bergerot P, Dorff T, Lyou Y, Frankel P, Llamas M, Hsu J, Zengin Z, Salgia N, Malhotra J, Chawla N, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Highlander S, Pal S. Intestinal microbiome associated with development of grade 3/4 adverse in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab (N/I) and probiotic support: Results from a phase Ib study. Journal Of Clinical Oncology 2022, 40: 374-374. DOI: 10.1200/jco.2022.40.6_suppl.374.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaSetting of mRCCStool microbiome compositionPhase Ib studyWeeks of therapyFirst-line treatmentLung cancer patientsRenal cell carcinomaMicrobiome compositionDevelopment of treatmentsB. thetaiotamicronMedian followMRCC patientsAdverse eventsData cutoffOverall cohortIntervention armLine treatmentCell carcinomaCancer patientsTRAEsStool samplesStool specimensIntestinal microbiomeLarge cohort
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