Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

Related Clinical Trial
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab A Study of RC48-ADC in Patients With HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Carcinoma Multimodal Spectroscopy to Detect Urothelial Cancer in Urine A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas A Study of ICP-192 in Patients With Advanced Solid Tumors Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma Fear of Cancer Recurrence in Genitourinary Cancer Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV A Multicenter Cancer Biospecimen Collection Study Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications LITT and Pembrolizumab in Recurrent Brain Metastasis Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s) Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma A Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers A Study of ZN-c3 in Participants With Solid Tumors Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors TPST-1120 as Monotherapy and in Combination With (Nivolumab, Docetaxel or Cetuximab) in Subjects With Advanced Cancers SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors GEN1046 Safety Trial in Patients With Malignant Solid Tumors Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors Study of the CD40 Agonistic Monoclonal Antibody APX005M A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian Cancer Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer B-Receptor Signaling in Cardiomyopathy Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Development of Diagnostics and Treatment of Urological Cancers Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response A Study of Personalized Neoantigen Cancer Vaccines A Study Combining the M3814 Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer Patients A Study Evaluating MM-310 in Patients With Solid Tumors MV-NIS or Investigator’s Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer Study of INBRX-106 in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) Study of INBRX-105 in Patients With Solid Tumors, Hodgkin or Non-Hodgkin Lymphoma Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery or Gynecological Cancers The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR) Water Versus Saline as Irrigation Fluid for Ureteroscopy A Study of a Personalized Neoantigen Cancer Vaccine Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies. QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients With Advanced Cancer Prospective Trial for Examining Hematuria Using Computed Tomography Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer Trial of CRLX101, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial Expressing Personalized Tumor Antigens Study Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors The Efficacy and Safety of UGN-102 as a Primary Chemoablative Therapy in Patients With LG NMIBC at Intermediate Risk of Recurrence A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors ( PIVOT-02 ) A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects Relationship of Ochratoxin A to Upper Urologic Cancers Patient-reported Outcomes in Bladder Cancer Confocal Laser Endomicroscopy in the Lower Urinary Tract Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Select Advanced or Metastatic Solid Tumors A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer CHEckpoint Inhibition in Combination With an Immunoboost of External Body Radiotherapy in Solid Tumors QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer A Study of RC48-ADC(Antibody Drug Conjugate) and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer Derazantinib and Atezolizumab in Patients With Urothelial Cancer Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer Predictive Factorsfor Final Pathologic Ureteral Sections The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function A Study of BBI503 in Adult Patients With Advanced Urologic Malignancies The Cxbladder Hematuria Clinical Utility Study Cabozantinib for Advanced Urothelial Cancer A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT) Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 (Cetrelimab), an Anti-PD-1 Monoclonal Antibody, in Participants With Metastatic or Locally Advanced Urothelial Cancer With Selected FGFR Gene Alterations PF-03446962 in Relapsed or Refractory Urothelial Cancer Improve Checkpoint-blockade Response in Advanced Urothelial Cancer Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer Efficacy and Safety of UGN-101 in Recurrent Patients Prospective Multicentric Evaluation of a Bladder Preservation Strategy Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy ADAPT-BLADDER: Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder Evaluation of NanoDoce® in Participants With Urothelial Carcinoma Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma SAbR Induced Innate Immunity in Urothelial Carcinoma, Melanoma, and Cervical Carcinoma Single Agent Abraxane as Second Line Therapy in Bladder Cancer KYN-175 in Patients With Advanced or Metastatic Solid Tumors and Urothelial Carcinoma A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer JAVLOR® Online Non-Interventional Trial A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce) Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma Alisertib in Chemotherapy-pretreated Urothelial Cancer Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence Study of Sitravatinib and Nivolumab in Urothelial Carcinoma Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence Biological Effect of Vitamin D in Patients With Urothelial Carcinoma Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma Arsenic Methylation Enzymes, Cigarette Metabolites, DNA Repair Enzymes, Inflammatory Factors and Urothelial Carcinoma Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma A Study on Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Urothelial Carcinoma Study of Tipifarnib in Patients With Previously-Treated, Advanced, HRAS Mutant Urothelial Carcinoma First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma Four Cycles Versus Six Cycles of Cisplatin-based Chemotherapy in Metastatic Urothelial Carcinoma Study of Pembrolizumab and Ramucirumab in Pts With Progressive TCC After Treatment With an Immune Checkpoint Inhibitor A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC) Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC Weekly TP-HDFL in the Treatment of Advanced TCC Detecting Transitional Cell Carcinoma From Haematuria Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU) Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma Vasculogenic Mimicry in Urothelial Carcinoma Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma DNA Methylation and Urothelial Carcinoma JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin DNA Methylation and Arsenic-associated Urothelial Carcinoma Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Brief Title

Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

Official Title

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

Brief Summary

      The purpose of this study is to evaluate the efficacy and safety of lenvatinib
      (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of
      cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined
      Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing
      chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma
      (UC).

      The primary hypotheses for this study are that:

        1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
           Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version
           1.1 (RECIST 1.1) by blinded independent central review (BICR), and

        2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
           Overall Survival (OS).
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary Outcome

 Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)

Condition

Urothelial Carcinoma

Intervention

Pembrolizumab

Study Arms / Comparison Groups

 Pembrolizumab+Lenvatinib
Description:  Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. Lenvatinib may be continued past 35 cycles until a discontinuation criterion is met.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

694

Start Date

May 6, 2019

Completion Date

October 31, 2023

Primary Completion Date

October 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Has a histologically or cytologically confirmed diagnosis of advanced/unresectable
             (inoperable) or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter
             (upper urinary tract), bladder, or urethra.

          -  Has ≥1 measurable target lesion per RECIST 1.1 as assessed by the local site
             investigator/radiologist.

          -  Has provided an archival tumor tissue sample or newly obtained core or excisional
             biopsy of a tumor lesion not previously irradiated and adequate for Programmed
             Death-Ligand 1 (PD-L1) evaluation.

          -  Has received no prior systemic chemotherapy for advanced or metastatic UC with the
             following exceptions:

          -  Neoadjuvant (prior to surgery) platinum-based chemotherapy for treatment of
             muscle-invasive bladder cancer with recurrence >12 months from completion of the
             therapy is permitted.

          -  Adjuvant (following surgery) platinum-based chemotherapy following radical cystectomy,
             with recurrence >12 months from completion of the therapy, is permitted.

          -  Meets criteria for either option a or option b (below):

          -  a. Has a tumor(s) with PD-L1 combined positive score (CPS) ≥10 and is considered
             ineligible to receive cisplatin-based combination therapy, based on 1 of the
             following:

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7
             days prior to randomization

          -  National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
             Version 4.0 Grade ≥2 audiometric hearing loss

          -  NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy OR

          -  b. In the opinion of the investigator, is considered ineligible to receive any
             platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:

          -  ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following:

          -  Documented visceral metastatic disease

          -  NCI CTCAE Version 4.0 Grade ≥2 audiometric hearing loss

          -  NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy

          -  Other reason for the participant's being unable to receive both cisplatin and
             carboplatin safely. Additional criteria for platinum ineligibility will be considered
             and allowed on a case-by-case basis, following consultation with the Sponsor. Note:
             Participants considered ineligible for any platinum-based chemotherapy are eligible
             for this study regardless of their tumor PD-L1 status.

          -  Has ECOG PS 0, 1, or 2 within 7 days prior to randomization and a life expectancy of
             ≥3 months.

          -  Male participants are eligible to participate if they agree to the following during
             the treatment period and for ≥30 days after the last dose of pembrolizumab or
             lenvatinib/placebo:

          -  Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and
             agree to remain abstinent, OR

          -  Must agree to use contraception unless confirmed to be azoospermic (vasectomized or
             secondary to medical cause as detailed below:

          -  Agrees to use a male condom plus partner use of an additional contraceptive method
             when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP)
             who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must
             agree to remain abstinent from penile-vaginal intercourse or use a male condom during
             each episode of penile-vaginal penetration.

          -  A female participant is eligible to participate if she is not pregnant or
             breastfeeding and if she is not a WOCBP OR is a WOCBP and is using a contraceptive
             method that is highly effective (with a failure rate of <1% per year) with low user
             dependency, or is abstinent from heterosexual intercourse as her preferred and usual
             lifestyle during the intervention period and for ≥120 days post pembrolizumab or ≥30
             days post lenvatinib/placebo.

          -  Has adequately controlled blood pressure (BP) with or without antihypertensive
             medications, defined as BP ≤150/90 mm Hg at screening and no change in
             antihypertensive medications within 1 week prior to randomization.

          -  Has adequate organ function.

        Exclusion Criteria:

          -  Has disease that is suitable for local therapy administered with curative intent (e.g.
             chemotherapy and radiation for Stage 3 disease).

          -  Has tumor with any neuroendocrine or small cell component.

          -  Has a history of a gastrointestinal condition or procedure (e.g. gastric bypass,
             malabsorption) that, in the opinion of the investigator, may affect oral drug
             absorption.

          -  Has had major surgery within 3 weeks prior to the first dose of study treatment

          -  Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.

          -  Has radiographic evidence of major blood vessel invasion/infiltration, or has had
             clinically significant hemoptysis (≥0.5 teaspoon of bright red blood) or tumor
             bleeding within 2 weeks prior to the first dose of study treatment.

          -  Has had significant cardiovascular impairment within 12 months of the first dose of
             study treatment, such as history of New York Heart Association (NYHA) >Class II
             congestive heart failure, unstable angina, myocardial infarction or cerebrovascular
             accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia
             associated with hemodynamic instability.

          -  Has known intolerance or severe hypersensitivity (Grade ≥3) to pembrolizumab or
             lenvatinib or any of their excipients

          -  Has received lenvatinib as monotherapy or in combination with a programmed cell
             death-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitor or has previously been
             enrolled in a clinical study evaluating lenvatinib for bladder cancer, regardless of
             the treatment received.

          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 inhibitor,
             indoleamine-pyrrole 2,3 dioxygenase (IDO1) inhibitor, or agent directed to another
             stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated
             antigen 4 [CTLA-4], OX 40, CD137), or any other antibody or drug targeting T-cell
             costimulatory pathways in the adjuvant or advanced/metastatic setting.

          -  Has received prior radiotherapy to a metastatic site without the use of chemotherapy
             radiosensitization within 3 weeks of the first dose of study treatment, with the
             exception of palliative radiotherapy to bone lesions, which is allowed if completed 2
             weeks before the start of study treatment. Participants must have recovered from all
             radiation-related toxicities, and must not require corticosteroids.

          -  Has received a live vaccine within 30 days prior to the first dose of study treatment.

          -  In the investigator's judgment, has not recovered from toxicity or other complications
             from any major surgery prior to starting study treatment.

          -  Is currently participating in or has participated in a study of an investigational
             agent or has used an investigational device within 4 weeks prior to the first dose of
             study treatment. Note: Participants who have entered the follow-up phase of an
             investigational study may participate as long as it has been 4 weeks after the last
             dose of the previous investigational agent.

          -  Has history or presence of an abnormal electrocardiogram (ECG) that, in the
             investigator's opinion, is clinically meaningful.

          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a
             dose exceeding 10 mg daily of prednisone equivalent) or any other form of
             immunosuppressive therapy within 7 days prior to randomization.

          -  Has had an active malignancy (except locally advanced or metastatic UC) within the
             past 36 months. Note: Participants with basal cell carcinoma of the skin, squamous
             cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical
             cancer in situ) who have undergone potentially curative therapy are not excluded.

          -  Has a history of prostate cancer (T2NXMX or lower with Gleason score ≤7) treated with
             definitive intent (surgically or with radiation therapy) ≥1 year prior to study entry
             is acceptable, provided that the participant is considered prostate cancer-free.

          -  Has central nervous system (CNS) metastases, unless the participant has completed
             local therapy (e.g. whole brain radiation therapy, surgery, or radiosurgery) and has
             discontinued use of corticosteroids for this indication for ≥4 weeks before starting
             study treatment. Any signs (e.g. radiologic) or symptoms of CNS metastases must be
             stable for ≥4 weeks before starting study treatment.

          -  Has an active autoimmune disease that has required systemic treatment in the past 2
             years (i.e, with disease-modifying agents, corticosteroids, or immunosuppressive
             drugs).

          -  Has a history of (non-infectious) pneumonitis that required systemic steroids, or
             current pneumonitis.

          -  Has an active infection requiring systemic therapy.

          -  Has a known history of human immunodeficiency virus (HIV) infection.

          -  Has a known history of or is positive for active hepatitis B virus (HBV) or has active
             hepatitis C virus (HCV).

          -  Has active tuberculosis (TB).

          -  Is receiving hemodialysis.

          -  Is pregnant or breastfeeding or expecting to conceive or father children within the
             projected duration of the study, starting with the screening visit through 120 days
             after the last dose of pembrolizumab and lenvatinib/placebo.

          -  Has had an allogeneic tissue/solid organ transplant.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Director, 1-888-577-8839, [email protected]

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03898180

Organization ID

7902-011

Secondary IDs

2018-003752-21

Responsible Party

Sponsor

Study Sponsor

Merck Sharp & Dohme Corp.

Collaborators

 Eisai Inc.

Study Sponsor

Medical Director, Study Director, Merck Sharp & Dohme Corp.


Verification Date

June 2021