2024
1968P Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (CIS)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC)
Rosenberg J, Petrylak D, Flaig T, Hoimes C, Gupta S, O'Donnell P, Mar N, Friedlander T, Tagawa S, Bilen M, Brown J, McKay R, Merchan J, Srinivas S, Shetty A, Moreno B, Davis G, Wirtz H, Zhu Y, Milowsky M. 1968P Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (CIS)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC). Annals Of Oncology 2024, 35: s1139-s1140. DOI: 10.1016/j.annonc.2024.08.2053.Peer-Reviewed Original ResearchImpact of Prior Chemotherapy on Response to Second-line Pembrolizumab in Urothelial Cancer: Exploratory Analysis of the Phase 3 KEYNOTE-045 Trial
de Wit R, Vaughn D, Fradet Y, Fong L, Climent M, Necchi A, Petrylak D, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Bajorin D, Choueiri T, Xu J, Imai K, Homet Moreno B, Bellmunt J, Lee J. Impact of Prior Chemotherapy on Response to Second-line Pembrolizumab in Urothelial Cancer: Exploratory Analysis of the Phase 3 KEYNOTE-045 Trial. European Urology 2024 PMID: 39174409, DOI: 10.1016/j.eururo.2024.07.015.Peer-Reviewed Original ResearchPlatinum-based chemotherapyDuration of responseFirst-line platinum-based chemotherapySecond-line pembrolizumabUrothelial carcinomaProgressive diseaseOverall survivalResponse to first-line platinum-based chemotherapyMedian duration of responsePlatinum-based combination chemotherapyStandard first-line treatmentStandard-of-care treatmentAdvanced urothelial carcinomaAvelumab maintenance therapyResponse to pembrolizumabSolid Tumors versionResponse Evaluation CriteriaEfficacy of pembrolizumabSecond-line treatmentFirst-line treatmentPost hoc analysisAdvanced UCMedian OSPembrolizumab monotherapyPrior chemotherapyA phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design.
Sadeghi S, Plets M, Lara P, Tangen C, Berg S, Brown J, Bangs R, Nakagawa D, Daneshmand S, Ian M. Jr., Flaig T, Petrylak D, Lerner S. A phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design. Journal Of Clinical Oncology 2024, 42: tps4617-tps4617. DOI: 10.1200/jco.2024.42.16_suppl.tps4617.Peer-Reviewed Original ResearchProgression free survivalMetastatic urothelial carcinomaMedian progression free survivalStandard of careOverall survivalEnfortumab vedotinSacituzumab govitecanFree survivalCisplatin-ineligible metastatic urothelial carcinomaPhase III randomized trialMedian overall survivalStudies of eribulinEndpoint of OSFGFR alterationsLiver metastasesSystemic therapyEligible ptsUrothelial carcinomaPrimary endpointGenitourinary cancersTreatment changesEribulinResponse rateActivity of EORRAvelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with histological subtypes.
Loriot Y, Gupta S, Powles T, Grivas P, Petrylak D, Tyroller K, Jacob N, Hoffman J, Bellmunt J. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with histological subtypes. Journal Of Clinical Oncology 2024, 42: 4567-4567. DOI: 10.1200/jco.2024.42.16_suppl.4567.Peer-Reviewed Original ResearchAdvanced urothelial carcinomaTreatment-related adverse eventsPlatinum-based chemotherapyProgression-free survivalBSC-alone armHistological subtypesLong-term outcomesOverall survivalPost hoc analysisTreatment guidelinesAnalysis of long-term outcomesStandard-of-care treatmentMedian follow-upOverall populationLong-term efficacyInternational treatment guidelinesLong-term safetyJAVELIN BladderMetastatic UCSafety populationData cutoffEligible ptsUrothelial carcinomaFirst-linePrimary endpointTROPHY-U-01, a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors: updated safety and efficacy outcomes
Loriot Y, Petrylak D, Kalebasty A, Fléchon A, Jain R, Gupta S, Bupathi M, Beuzeboc P, Palmbos P, Balar A, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zhou H, Grivas P, Barthélémy P, Tagawa S. TROPHY-U-01, a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors: updated safety and efficacy outcomes. Annals Of Oncology 2024, 35: 392-401. PMID: 38244927, DOI: 10.1016/j.annonc.2024.01.002.Peer-Reviewed Original ResearchAssociated with increased adverse eventsMetastatic urothelial carcinomaProgression-free survivalPlatinum-based chemotherapySacituzumab govitecanUGT1A1 statusFollow-upCohort 1Checkpoint inhibitorsOverall survivalUrothelial carcinomaAccelerated US Food and Drug Administration approvalPhase II open-label studyTreated with platinum-based chemotherapyMedian progression-free survivalUS Food and Drug Administration approvalActive metabolite of irinotecanFood and Drug Administration approvalIrinotecan-based therapyTreatment-related discontinuationsUridine diphosphate glucuronosyltransferase 1A1Metabolite of irinotecanInhibitor-based therapyDrug Administration approvalAntibody-drug conjugatesEfficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review
Grant M, Stockhammer P, Austin M, Nemeth Z, Petrylak D. Efficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review. Bladder Cancer 2024, 10: 9-23. PMID: 38993528, PMCID: PMC11181835, DOI: 10.3233/blc-230070.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaAntibody-drug conjugatesClinical trialsUrothelial carcinomaCombination regimensDrug conjugatesSystematic reviewAnti-PD-1 agentsProspective therapeutic clinical trialsCochrane Central TrialsClinical trial cohortObjective response rateTherapeutic clinical trialsMeta-Analyses (PRISMA) statementNon-duplicated articlesPreferred Reporting ItemsComprehensive systematic reviewPotent cytotoxic payloadTrial cohortEnfortumab vedotinOvid EmbaseSacituzumab govitecanADC targetImpressive efficacyOvid MEDLINE
2023
Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma
Petrylak D, Eigl B, George S, Heath E, Hotte S, Chism D, Nabell L, Picus J, Cheng S, Appleman L, Sonpavde G, Morgans A, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu E. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clinical Cancer Research 2023, 30: of1-of11. PMID: 37861407, PMCID: PMC10767306, DOI: 10.1158/1078-0432.ccr-22-3627.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaObjective response rateDose-limiting toxicityAntibody-drug conjugatesUrothelial carcinomaCommon treatment-emergent adverse eventsInvestigational antibody-drug conjugateTreatment-emergent adverse eventsI dose-escalation studyDose-expansion cohortsCheckpoint inhibitor therapyPhase II doseDose-escalation studyDose-proportional mannerMultiple-dose administrationBest overall responseMonomethyl auristatin ECytotoxic drug monomethyl auristatin EPrior chemotherapyAdverse eventsDose escalationInhibitor therapyPeripheral neuropathyOcular toxicityExpansion trialAvelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance
Sridhar S, Powles T, Climent Durán M, Park S, Massari F, Thiery-Vuillemin A, Valderrama B, Ullén A, Tsuchiya N, Aragon-Ching J, Gupta S, Petrylak D, Bellmunt J, Wang J, Laliberte R, di Pietro A, Costa N, Grivas P, Sternberg C, Loriot Y. Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance. European Urology 2023, 85: 154-163. PMID: 37714742, DOI: 10.1016/j.eururo.2023.08.001.Peer-Reviewed Original ResearchBest supportive careProgression-free survivalAdvanced urothelial carcinomaFirst-line chemotherapyPlatinum-based chemotherapyOverall survivalFirst-line maintenanceChemotherapy durationMaintenance treatmentUrothelial carcinomaFirst-line platinum-based chemotherapyAnalysis of OSAdvanced urothelial cancerPhase 3 trialAnalysis of subgroupsAdvanced UCPrior chemotherapyProspective trialSafety findingsSupportive careHazard ratioUrothelial cancerDisease progressionChemotherapyOverall populationEV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefitA phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2023, 41: tps4608-tps4608. DOI: 10.1200/jco.2023.41.16_suppl.tps4608.Peer-Reviewed Original ResearchStandard of careMedian overall survivalObjective response rateProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersAvelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial
Grivas P, Park S, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullén A, Loriot Y, Sridhar S, Yamamoto Y, Petrylak D, Sternberg C, Gupta S, Huang B, Costa N, Laliberte R, di Pietro A, Valderrama B, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. European Urology 2023, 84: 95-108. PMID: 37121850, DOI: 10.1016/j.eururo.2023.03.030.Peer-Reviewed Original ResearchConceptsBest supportive careProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyOverall survivalHazard ratioUrothelial carcinomaAnalysis of OSFirst-line maintenance therapyRelevant subgroupsCox proportional hazards modelClinical subgroup analysisPhase 3 trialKaplan-Meier methodProportional hazards modelFirst-line maintenanceMetastatic UCMaintenance therapyStable diseaseSupportive careComplete responsePartial responseAdvanced cancerPD-L1Maintenance treatmentA phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2023, 41: tps581-tps581. DOI: 10.1200/jco.2023.41.6_suppl.tps581.Peer-Reviewed Original ResearchStandard of careObjective response rateMedian overall survivalProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancers
2022
Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆
Balar A, Castellano D, Grivas P, Vaughn D, Powles T, Vuky J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Necchi A, Petrylak D, Plimack E, Xu J, Imai K, Moreno B, Bellmunt J, de Wit R, O’Donnell P. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆. Annals Of Oncology 2022, 34: 289-299. PMID: 36494006, DOI: 10.1016/j.annonc.2022.11.012.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaBlinded independent central reviewCisplatin-ineligible patientsObjective response rateRECIST version 1.1Years of followUrothelial carcinomaKEYNOTE-045KEYNOTE-052Primary endpointMost treatment-related adverse eventsResponse rateSurvival rateConfirmed objective response rateTreatment-related adverse eventsProgression-free survival ratesFurther safety concernsPlatinum-containing chemotherapyFirst-line therapyImmune checkpoint inhibitorsNew safety signalsProgression-free survivalDurability of responseFirst-line pembrolizumabOverall survival rateFORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. Journal Of Clinical Oncology 2022, 41: 629-639. PMID: 36240478, PMCID: PMC9870218, DOI: 10.1200/jco.21.02303.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaUrothelial carcinomaOverall survivalComparable efficacyPan-fibroblast growth factor receptor inhibitorPhase II/III studyPrior platinum-containing regimenPhase II/IIIMRNA overexpressionGrowth factor receptor inhibitorsFGFR-directed therapiesGrade 3/4 eventsMedian overall survivalPlatinum-containing regimenPrimary end pointAdvanced urothelial carcinomaOpen-label trialDNA alterationsVersus ChemotherapyIII studyManageable safetyPlatinum chemotherapyResponse rate analysisReceptor inhibitorsInterim analysisA phase III randomized trial of eribulin (E) with or without gemcitabine versus standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine versus standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2022, 40: tps4608-tps4608. DOI: 10.1200/jco.2022.40.16_suppl.tps4608.Peer-Reviewed Original ResearchStandard of careMedian overall survivalObjective response rateProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersLong-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma.
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. Journal Of Clinical Oncology 2022, 40: 4516-4516. DOI: 10.1200/jco.2022.40.16_suppl.4516.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalStandard chemotherapyUrothelial carcinomaInterim analysisInvestigator-assessed progression-free survivalLong-term clinical profilesPrior platinum-containing chemotherapyTreatment-related adverse eventsPrespecified interim analysisRobust clinical benefitTolerable safety profileAdvanced urothelial carcinomaMedian overall survivalMetastatic urothelial carcinomaPlatinum-containing chemotherapyNew safety signalsPhase 3 trialRate of gradeLonger overall survivalLong-term outcomesStandard of careAntibody-drug conjugatesConsistent survival advantageOS benefitPD10-02 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: LONG-TERM FOLLOW-UP RESULTS FROM THE JAVELIN BLADDER 100 TRIAL
Grivas P, Bellmunt J, Park H, Voog E, Caserta C, Valderrama B, Gurney H, Loriot Y, Sridhar S, Tsuchiya N, Sternberg C, Aragon-Ching J, Petrylak D, Blake-Haskins J, Laliberte R, Wang J, Costa N, Powles T. PD10-02 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: LONG-TERM FOLLOW-UP RESULTS FROM THE JAVELIN BLADDER 100 TRIAL. Journal Of Urology 2022, 207: e183. DOI: 10.1097/ju.0000000000002536.02.Peer-Reviewed Original ResearchAvelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial.
Powles T, Park H, Voog E, Caserta C, Pérez-Valderrama B, Gurney H, Loriot Y, Sridhar S, Tsuchiya N, Sternberg C, Bellmunt J, Aragon-Ching J, Petrylak D, Blake-Haskins A, Laliberte R, Wang J, Costa N, Grivas P. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. Journal Of Clinical Oncology 2022, 40: 487-487. DOI: 10.1200/jco.2022.40.6_suppl.487.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaProgression-free survivalPlatinum-containing chemotherapyUrothelial carcinomaOverall survivalPD-L1Metastatic urothelial carcinomaNew safety signalsLonger overall survivalLong-term followStandard of careLong-term safetyFirst-line maintenanceAnticancer drug therapyOS benefitProlonged OSMonotherapy studiesPrimary endpointSecondary endpointsAlone armPrespecified subgroupsSupportive careTreatment guidelinesDrug therapyImpact of primary tumor location on efficacy and safety of pembrolizumab (pembro) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials.
O'Donnell P, Balar A, Castellano D, De Wit R, Vaughn D, Powles T, Vuky J, Lee J, Fradet Y, Bellmunt J, Fong L, Petrylak D, Gerritsen W, Quinn D, Culine S, Bajorin D, Xu J, Imai K, Moreno B, Grivas P. Impact of primary tumor location on efficacy and safety of pembrolizumab (pembro) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials. Journal Of Clinical Oncology 2022, 40: 516-516. DOI: 10.1200/jco.2022.40.6_suppl.516.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPrimary tumor locationKEYNOTE-045KEYNOTE-052Urothelial carcinomaTumor locationRECIST v1.1Primary tumorSafety of pembrolizumabSimilar clinical activityWithdrawal of consentMeasurable diseaseData cutoffManageable safetyUnacceptable toxicitySystemic therapyPD-L1Positive tumorsRenal pelvisDisease progressionPembroSimilar efficacyClinical activityGrade 3UT groupRandomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011).
Sonpavde G, Plets M, Liss M, Meeks J, Petrylak D, Cole S, McKay R, Gupta S, Hita S, Pereira T, Bangs R, Tangen C, Thompson I, Lerner S. Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011). Journal Of Clinical Oncology 2022, 40: tps591-tps591. DOI: 10.1200/jco.2022.40.6_suppl.tps591.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaMuscle-invasive bladder cancerUpper tract urothelial carcinomaImmune checkpoint inhibitorsWeeks x 4 cyclesPathologic complete remissionEvent-free survivalPhase II trialUpfront surgeryUrothelial carcinomaDay 1II trialNeoadjuvant therapyOverall survivalHigh-risk upper tract urothelial carcinomaCisplatin-ineligible metastatic urothelial carcinomaNeoadjuvant cisplatin-based combination chemotherapyOpen-label phase II trialHigh grade upper tract urothelial carcinomaNeoadjuvant immune checkpoint inhibitorsRandomized phase II trialCisplatin-based combination chemotherapyCisplatin-eligible patientsMetastatic urothelial carcinomaPD-L1 inhibitors