2023
Association Between Time-of-Day of Immune Checkpoint Blockade Administration and Outcomes in Metastatic Renal Cell Carcinoma
Dizman N, Govindarajan A, Zengin Z, Meza L, Tripathi N, Sayegh N, Castro D, Chan E, Lee K, Prajapati S, Feng M, Loo V, Pace M, O'Brien S, Bailey E, Barragan-Carrillo R, Chehrazi-Raffle A, Hsu J, Li X, Agarwal N, Pal S. Association Between Time-of-Day of Immune Checkpoint Blockade Administration and Outcomes in Metastatic Renal Cell Carcinoma. Clinical Genitourinary Cancer 2023, 21: 530-536. PMID: 37495481, DOI: 10.1016/j.clgc.2023.06.004.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaObjective response rateTreatment failureRenal cell carcinomaHazard ratioOverall survivalCell carcinomaMultivariate analysisHigh Cut-OffNivolumab/ipilimumabProspective Randomized StudyBaseline characteristicsRandomized studyClinical outcomesMedian timePreclinical evidenceUnivariate analysisPatientsResponse rateImmune systemInfusion timeStatistical significanceOutcomesCarcinomaInfusionUltrasensitive Circulating Tumor DNA Pilot Study Distinguishes Complete Response and Partial Response With Immunotherapy in Patients With Metastatic Renal Cell Carcinoma
Chehrazi-Raffle A, Muddasani R, Dizman N, Hsu J, Meza L, Zengin Z, Malhotra J, Chawla N, Dorff T, Contente-Cuomo T, Dinwiddie D, McDonald B, McDaniel T, Trent J, Baehner F, Murtaza M, Pal S. Ultrasensitive Circulating Tumor DNA Pilot Study Distinguishes Complete Response and Partial Response With Immunotherapy in Patients With Metastatic Renal Cell Carcinoma. JCO Precision Oncology 2023, 7: e2200543. PMID: 37027813, PMCID: PMC10309555, DOI: 10.1200/po.22.00543.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaPartial responseComplete responseVariant allele fractionRenal cell carcinomaCell carcinomaCtDNA analysisImmune checkpoint inhibitor therapyCheckpoint inhibitor therapyDiscontinuation of immunotherapyDepth of responseICI therapyNivolumab monotherapyEligible patientsRadiographic progressionInhibitor therapyPeripheral bloodDisease progressionCtDNA assessmentSubsequent progressionPatientsMultiple indicationsSingle time pointPatient-specific mutationsSecondary objective
2022
Nivolumab 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