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
2022
FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy
Choueiri T, Kluger H, George S, Tykodi S, Kuzel T, Perets R, Nair S, Procopio G, Carducci M, Castonguay V, Folefac E, Lee C, Hotte S, Miller W, Saggi S, Lee C, Desilva H, Bhagavatheeswaran P, Motzer R, Escudier B. FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy. Journal For ImmunoTherapy Of Cancer 2022, 10: e005780. PMID: 36328377, PMCID: PMC9639138, DOI: 10.1136/jitc-2022-005780.Peer-Reviewed Original ResearchConceptsAdvanced renal cell carcinomaObjective response rateDuration of responseIO therapyImmuno-oncology therapiesRenal cell carcinomaOverall survivalCell carcinomaAnti-PD-1/PD-L1 therapyImmune-mediated adverse eventsMedian DORProgression-free survival ratesTreatment-related deathsManageable safety profileMedian overall survivalPD-L1 therapyDurable clinical benefitKarnofsky performance statusPrimary outcome measureHigh unmet needExploratory endpointsIpilimumab armPFS ratesStable diseaseAdverse eventsNivolumab/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 study
2017
A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): Preliminary safety and efficacy of the ipilimumab arms.
Tarhini A, Lee S, Hodi F, Rao U, Cohen G, Hamid O, Hutchins L, Sosman J, Kluger H, Sondak V, Koon H, Lawrence D, Kendra K, Minor D, Lee C, Albertini M, Flaherty L, Petrella T, Kirkwood J. A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): Preliminary safety and efficacy of the ipilimumab arms. Journal Of Clinical Oncology 2017, 35: 9500-9500. DOI: 10.1200/jco.2017.35.15_suppl.9500.Peer-Reviewed Original ResearchHigh-dose interferon-alfaHigh-risk melanomaAdverse eventsAdjuvant therapyRFS analysisHigh-dose interferon alfa-2bThree-year RFS ratesTreatment related adverse eventsRelative safetyDiscontinuation of treatmentInterferon alfa-2bRelated adverse eventsCo-primary endpointsRegulatory approvalAdjuvant ipilimumabAdult ptsInoperable melanomaIpilimumab armInterferon alfaAlfa-2bRFS ratesPreliminary safetyDose levelsRecent approvalMelanoma
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