Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Related Clinical Trial
Phase I BLASST-3 Trial Bio Clinical Collection of Urothelial Carcinoma Glycosylation of Exosomes in Prostate and Urothelial Carcinoma Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression Efficacy and Utility of Cxbladder Tests in Hematuria Patients Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies 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

Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Official Title

Pilot Evaluation of Focused Ultrasound Ablation and Focused Ultrasound Ablation Plus PD-1 Antibody Blockade in Advanced Solid Tumors

Brief Summary

      This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with
      and without PD-1 blockade and with and without imiquimod. A device called the Echopulse will
      be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their
      disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving
      PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who
      discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent
      systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response.
      The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with imiquimod, which is
      a topical TLR7 agonist.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

To assess the safety and toxicity of FUSA administered alone or in combination with PD-1 antibody blockade.

Secondary Outcome

 To estimate the proportion of patients with increased CD8+ T cell infiltration, after spot FUSA, in untreated metastasis, when available.

Condition

Melanoma

Intervention

Echopulse

Study Arms / Comparison Groups

 Cohort 1, primary regimen (Regimen 1a)
Description:  FUSA therapy and standard of care PD-1 blockade. FUSA therapy will be administered on day 8.

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

Device

Estimated Enrollment

32

Start Date

November 21, 2019

Completion Date

May 30, 2023

Primary Completion Date

November 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥18 years.

          2. Advanced solid tumor with measurable disease in regional and/or distant metastases.

          3. Subject must have failed or have contraindication to standard therapies

          4. For Cohort 1, primary regimen (Regimen 1a): Patients with advanced solid malignancy
             for which PD1 or PDL1 antibody monotherapy administered on a 3-week schedule is
             FDA-approved for treatment, who have one or more tumor deposits that are accessible to
             focused ultrasound treatment, and who are eligible to receive (or to continue to
             receive) PD1 or PDL1 blockade therapy. Uveal melanoma patients are not eligible for
             Regimen 1a.

             Note: These patients may receive the primary protocol therapy (Regimen 1a) concurrent
             with PD1/PDL1 antibody therapy even if they may be eligible for other effective
             FDA-approved therapies in the following settings:

             Patients with stable disease after 12 weeks of PD1/PDL1 therapy per RECIST criteria
             may be eligible for Regimen 1a if their disease has remained stable on therapy and if
             their treating physician would normally continue PD1/PDL1 therapy even if they were
             not treated on this trial.

          5. For Cohort 1, secondary regimen (Regimen 2a): For those patients treated with primary
             regimen 1a, select participants may be enrolled in a secondary regimen. This would
             include participants in the following scenarios:

               -  Stable disease.

               -  Response in lesion treated in regimen 1, but persistent disease or progression in
                  a separate lesion.

               -  Initial partial response but still persistent disease at the treated lesion.

               -  Initial response followed by progression at treated lesion or separate site,
                  after discontinuation of PD-1/PD-L1 antibody. If there is a response and then
                  progression at the site treated in Regimen 1 and the residual tumor meets
                  inclusion criteria, this lesion may be re-treated on the secondary regimen. For
                  participants who progress at a site unique from the treated lesion, they may
                  enroll in Regimen 2 and have this new lesion treated, as long as they meet all
                  inclusion criteria requirements.

             The patient must have a treatable tumor deposit in the dermis. The lesion to be FUSA
             treated in regimen 2 does not need to be the same lesion targeted in regimen 1. The
             patient must remain eligible for PD1/PDL1 Ab therapy. The length between the FUSA
             treatments in primary regimen and secondary regimen should be no less than 6 weeks.
             Patients who experienced an unanticipated device effect in the primary regimen are not
             eligible for the secondary regimen.

          6. For Cohort 2, primary regimen (Regimen 1b): The following patient subsets would be
             eligible for the Cohort 2 primary regimen, as long as they have failed (progressed or
             not tolerated) or are not eligible for all effective available approved therapies
             known to confer clinical benefit:

               -  Patients with advanced solid malignancy for which PD1 or PDL1 blockade is not
                  FDA-approved.

               -  Patients with metastatic uveal melanoma

               -  Patients with advanced solid malignancies for which PD1 or PDL1 blockade is FDA
                  approved but who are not eligible to receive that therapy because of prior
                  failure, toxicity, baseline autoimmune disease, or frailty.

               -  Patients who previously responded to PD1/PDL1 therapy but then progressed, if
                  there are no other systemic therapies available to them.

             Patients who were previously undergoing PD-1 blockade therapy must not have received a
             dose within 4 weeks prior to FUSA treatment.

          7. For Cohort 2, secondary regimen (Regimen 2b): For those patients treated with primary
             regimen 1a or 1b, select participants may be enrolled in a secondary regimen. This
             would include participants in the following scenarios:

               -  Stable disease.

               -  Response in lesion treated in regimen 1, but persistent disease or progression in
                  a separate lesion.

               -  Initial partial response but still persistent disease at the treated lesion.

               -  Initial response followed by progression at the treated lesion or a separate site
                  after discontinuation of PD-1/PD-L1 antibody. If there is a response and then
                  progression at the site treated in Regimen 1 and the residual tumor meets
                  inclusion criteria, this lesion may be re-treated on the secondary regimen. For
                  participants who progress at a site unique from the treated lesion, they may
                  enroll in Regimen 2 and have this new lesion treated, as long as they meet all
                  inclusion criteria requirements.

             Patients enrolling to Regimen 2b must have a treatable tumor deposit in the dermis.
             The lesion to be FUSA treated in regimen 2 does not need to be the same lesion
             targeted in regimen 1. Crossover from primary regimen 1a is allowed if the patient is
             no longer eligible for continued PD1/PDL1 Ab therapy (e.g. due to autoimmune
             toxicity), and if there is no other effective systemic therapy option. The length
             between the FUSA treatments in regimen 1 and regimen 2 should be no less than 6 weeks.
             Patients who experienced an unanticipated device effect in the primary regimen are not
             eligible for the secondary regimen.

          8. One or more dermal, subcutaneous or nodal metastases from an advanced solid tumor. The
             metastases need to be accessible for FUSA and for biopsy.

             For FUSA:

             The targeted lesion(s) must be visible by ultrasound imaging and meet the following
             criteria. Brain lesions may not be targeted for treatment.

               -  Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be
                  treated with FUSA.

               -  The target treatment area needs to be contained within a region at least 5 mm
                  from the skin surface and less than or equal to 23 mm from the skin surface.

               -  The target treatment area must be at a safe distance from all critical
                  structures, including but not limited to ribs or other bony structures, vital
                  organs, named blood vessels or nerves.

               -  The critical structures, with the exception of the skin, will not be in the
                  pre-focal ultrasound path.

               -  The anterior-posterior dimension of the treatment area by US should be no less
                  than 9mm.

             For Biopsies:

             Biopsies may be completed with or without image guidance.

          9. Lesions that have been selected for focused ultrasound or lesions that have been
             selected for biopsies as untreated controls may have been previously radiated
             provided:

               -  The tumor site that was previously radiated has progressed.

               -  A baseline biopsy of the tumor site is obtained following progression and prior
                  to study entry.

         10. ECOG performance status 0-2.

         11. Subjects with brain metastases may participate if all of the following are true:

               -  There has been no evident growth of any brain metastasis since the most recent
                  treatment

               -  No brain metastasis is > 2 cm in diameter at the time of registration.

               -  Neurologic symptoms have returned to baseline,

               -  There is no evidence of new or enlarging brain metastases,

               -  Subjects are not using steroids for at least 7 days prior to registration.
                  Regardless of dose, however, subjects who are on a steroid taper for management
                  of brain metastases are not eligible until 7 days after completion of that
                  steroid taper.

               -  Brain metastases will not be targeted for FUSA treatment.

         12. Adequate organ function

         13. Ability and willingness to give informed consent.

        Exclusion Criteria:

        A subject will be excluded from participating in the trial if the subject:

          1. Has received the following medications or treatments at any time within 3 weeks of
             study day 1:

               1. Immune therapies including:

                    -  interferon (e.g. Intron-A®),

                    -  checkpoint blockade therapies other than anti-PD-1/PD-L1 antibodies,

                    -  antibodies to costimulatory molecules (e.g. CD27, CD137),

                    -  small molecule immune therapies (e.g. IDO1 inhibitor)

               2. Cytotoxic chemotherapy for cancer

          2. Has received the following medications or treatments at any time within 4 weeks of
             study day 1:

               1. Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be
                  used ≥ 1 week prior to registration)

               2. Allergy desensitization injections

               3. High doses of systemic corticosteroids, with the following qualifications and
                  exceptions:

                    -  Daily doses of 10 mg or less prednisone (or equivalent) per day administered
                       parenterally or orally are allowed in patients with normal adrenal and
                       pituitary function.

                    -  In patients with adrenal or pituitary insufficiency replacement steroid
                       doses are allowed.

                    -  Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low
                       doses (less than 500 mcg fluticasone per day, or equivalent)

                    -  Topical and nasal corticosteroids are acceptable.

               4. Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)

               5. Interleukins (e.g. Proleukin®)

               6. Any investigational medication

               7. Targeted therapies specific for mutated BRAF or for MEK

               8. Live vaccine

          3. Has a known addiction to alcohol or drugs and is actively taking those agents, or has
             recently (within 1 year) taken these agents or has ongoing illicit IV drug use.

          4. Is HIV positive or has evidence of active Hepatitis B or C virus (testing to be done
             within 6 months of study entry).

          5. Is currently receiving nitrosoureas or has received this therapy within the preceding
             6 weeks

          6. Is pregnant or breastfeeding. Female participants of childbearing potential must have
             a negative pregnancy test obtained within 2 weeks prior to registration. Males and
             females must agree, in the consent form, to use effective birth control methods during
             the course of treatment and following treatment in accordance with the labeling
             guidelines for each approved therapy.

          7. Has a medical contraindication or potential problem in complying with the requirements
             of the protocol in the opinion of the investigator.

          8. Has an active infection requiring systemic therapy.

          9. Has Class III or IV heart disease as classified according to the New York Heart
             Association.

         10. Has had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy,or
             autoimmune disorders with visceral involvement. Participants with an active autoimmune
             disorder requiring these therapies are also excluded.

             Note: The following are not exclusionary:

               -  The presence of laboratory evidence of autoimmune disease (e.g. positive ANA
                  titer) without symptoms

               -  Clinical evidence of vitiligo

               -  Other forms of depigmenting illness

               -  Mild arthritis requiring NSAID medications

               -  A history of immune-related adverse events with immune therapy, if the
                  immune-related adverse events have resolved completely.

         11. History of another cancer

             Note: the following diagnoses are exceptions and are permitted as long as they have
             been treated successfully and without clinical evidence of disease:

               -  Any cancer that has been treated successfully, without evidence of subsequent
                  recurrence or metastasis for over 5 years

               -  Any cancer without distant metastasis that has been treated successfully, without
                  evidence of recurrence or metastasis for over 2 years

               -  Squamous cell cancer of the skin without known metastasis

               -  Basal cell cancer of the skin without known metastasis

               -  Carcinoma in situ of the breast (DCIS or LCIS)

               -  Carcinoma in situ of the cervix

         12. Has a history of (non-infectious) pneumonitis that required steroids or current
             evidence of interstitial lung disease or pneumonitis.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lynn Dengel, MD, MSc, 14349826714, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04116320

Organization ID

21850


Responsible Party

Sponsor-Investigator

Study Sponsor

Craig L Slingluff, Jr

Collaborators

 Theraclion

Study Sponsor

Lynn Dengel, MD, MSc, Principal Investigator, University of Virginia


Verification Date

November 2020