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
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 studyCharacterizing IMDC prognostic groups in contemporary first-line combination therapies for metastatic renal cell carcinoma (mRCC).
Ernst M, Navani V, Wells J, Donskov F, Basappa N, Labaki C, Pal S, Meza L, Wood L, Ernst D, Szabados B, McKay R, Parnis F, Suárez C, Yuasa T, Kapoor A, Alva A, Bjarnason G, Choueiri T, Heng D. Characterizing IMDC prognostic groups in contemporary first-line combination therapies for metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2022, 40: 308-308. DOI: 10.1200/jco.2022.40.6_suppl.308.Peer-Reviewed Original ResearchInternational mRCC Database ConsortiumMetastatic renal cell carcinomaVascular endothelial growth factor-targeted therapyIpi-nivoImmuno-oncology agentsOverall survivalCombination therapyComplete responseFirst-lineFirst-line treatment of metastatic renal cell carcinomaTreatment of metastatic renal cell carcinomaInternational mRCC Database Consortium criteriaClinical trialsFirst-line combination therapyEfficacy of combination therapyNon-clear cell histologyTherapy to deathFirst-line treatmentLog-rank testRenal cell carcinomaReal-world survivalCell histologySarcomatoid featuresOS outcomesLiver metastases
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