2023
Assessment of short-chain fatty acid (SCFA) and circulating cytokine trends in a clinical trial of nivolumab/ipilimumab and CBM588 in metastatic renal cell carcinoma (mRCC).
Dizman N, Pathak K, Alcantara M, Meza L, Bergerot P, Willey M, Dorff T, Hsu J, Zengin Z, Castro D, Ebrahimi H, Chehrazi-Raffle A, Tripathi A, Trent J, Takahashi M, Oka K, Higashi S, Kortylewski M, Pirrotte P, Pal S. Assessment of short-chain fatty acid (SCFA) and circulating cytokine trends in a clinical trial of nivolumab/ipilimumab and CBM588 in metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2023, 41: 4556-4556. DOI: 10.1200/jco.2023.41.16_suppl.4556.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaNivolumab/ipilimumabObjective response rateShort-chain fatty acidsPlasma short-chain fatty acidsImmune checkpoint blockadeCheckpoint blockadeCytokine levelsSCFA levelsClinical trialsRandomized phase I clinical trialSarcomatoid Metastatic Renal Cell CarcinomaPhase I clinical trialStool SCFA levelsAcid levelsTreatment-naïve patientsAltered amino acid metabolismRenal cell carcinomaIpilimumab armNaïve patientsButyric acid levelsSerum cytokinesClinical outcomesCell carcinomaBiologic rationale
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