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

Related Clinical Trial
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis. A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study) Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) En Bloc TURBT With Collins Loop vs Conventional TURBT Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors 89Zr-girentuximab PET in Urothelial Cancer Patients Urothelial Tumor Risk Genes Detection With Genetron Uro V1 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

A Study Combining the Peposertib (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

Official Title

A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum - Resistant or Ineligible Ovarian and Related Cancers With Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)

Brief Summary

      This phase I trial studies the side effects and best dose of peposertib when given together
      with pegylated liposomal doxorubicin hydrochloride in treating patients with high or low
      grade ovarian cancer that has come back (recurrent). Peposertib may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,
      such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the
      growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
      stopping them from spreading. Giving peposertib and pegylated liposomal doxorubicin
      hydrochloride may work better in treating patients with ovarian cancer compared to pegylated
      liposomal doxorubicin hydrochloride alone.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. To determine the safety and tolerability of peposertib (M3814) in combination with
      pegylated liposomal doxorubicin hydrochloride (PLD) and determine the recommended phase 2
      dose (RP2D) of the combination in women with recurrent ovarian cancer.

      SECONDARY OBJECTIVES:

      I. To observe and record anti-tumor activity. II. To evaluate the pharmacokinetics of M3814
      when given in combination with PLD.

      EXPLORATORY OBJECTIVE:

      I. To correlate response to treatment (as defined by response rate and progression free
      survival) with PLD exposure (in area under the curve [AUC]) and PLD associated toxicities in
      women with recurrent high grade serous and low grade serous ovarian cancer treated in the
      expansion cohorts.

      OUTLINE: This is a dose-escalation study of peposertib followed by a dose-expansion study.

      Patients receive peposertib orally (PO) twice daily (BID) on days 1-21 or days 1-28 and
      pegylated liposomal doxorubicin hydrochloride intravenously (IV) on day 1. Cycles repeat
      every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 30 days.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of adverse events

Secondary Outcome

 Pharmacokinetics (PK) parameters of nedisertib

Condition

Fallopian Tube Clear Cell Adenocarcinoma

Intervention

Pegylated Liposomal Doxorubicin Hydrochloride

Study Arms / Comparison Groups

 Treatment (peposertib, PLD)
Description:  Patients receive peposertib PO BID on days 1-21 or days 1-28 and pegylated liposomal doxorubicin hydrochloride IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Drug

Estimated Enrollment

49

Start Date

February 24, 2020

Completion Date

September 1, 2022

Primary Completion Date

September 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  DOSE ESCALATION PHASE: Women with recurrent or persistent epithelial ovarian,
             fallopian tube or primary peritoneal cancer are eligible. This includes, but is not
             limited to, the following histologic types: serous adenocarcinoma (grade 1,2, or 3/
             high grade or low grade), endometrioid adenocarcinoma, mucinous adenocarcinoma,
             undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial
             adenocarcinoma, transitional cell carcinoma, or adenocarcinoma not otherwise specified

          -  EXPANSION PHASE: The expansion phase will simultaneously accrue to 2 cohorts, low
             grade serous ovarian cancer (LGSOC) and high grade serous ovarian cancer (HGSOC)

               -  Patients accrued to the LGSOC cohort will have recurrent or persistent low grade
                  serous ovarian cancer or grade 1 serous ovarian cancer

               -  Patients accrued to the HGSOC cohort will have recurrent or persistent high grade
                  serous ovarian cancer

          -  Patients must have measurable disease by defined Response Evaluation Criteria in Solid
             Tumors (RECIST) 1.1 criteria

          -  Prior therapy:

               -  Patients must have received at least one prior line of platinum-based
                  chemotherapy

               -  Patients can have received an unlimited number of additional lines of
                  chemotherapy, targeted therapy, biologic therapy, or hormonal therapy

               -  Any prior therapy directed at the malignant tumor, including chemotherapy,
                  biologic/targeted therapy, immunotherapy, or hormonal therapy must be
                  discontinued at least 4 weeks, one cycle, or 5 half-lives (whichever is shortest)
                  prior to study treatment initiation

          -  Patients with platinum-sensitive ovarian cancer are eligible for only the dose
             expansion phase if their provider feels that PLD would be an appropriate treatment
             option for them. Patients with platinum-sensitive ovarian cancer should also be
             offered any higher priority studies for which they are potentially eligible and/or
             platinum based chemotherapy or a PARP inhibitor if they are eligible for such therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Patients must have a cardiac ejection fraction >= the institutional lower limit of
             normal (LLN)

          -  Hemoglobin >= 9 g/dL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 3 x institutional ULN

          -  Alkaline phosphatase =< 2.5 x institutional ULN

          -  Creatinine clearance > 30 ml/min

          -  Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
             therapy with undetectable viral load within 6 months are eligible for this trial

          -  For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
             load must be undetectable on suppressive therapy, if indicated

          -  Patients with a history of hepatitis C virus (HCV) infection must have been treated
             and cured. For patients with HCV infection who are currently on treatment, they are
             eligible if they have an undetectable HCV viral load

          -  Patients with treated brain metastases are eligible if follow-up brain imaging after
             central nervous system (CNS)-directed therapy shows no evidence of progression. The
             patient must be off steroids and clinically stable

          -  Female patients of childbearing potential must have a negative urine or serum
             pregnancy test within 72 hours prior to receiving the first dose of study medication.
             If the urine test is positive or cannot be confirmed as negative, a serum pregnancy
             test will be required

               -  The effects of peposertib (M3814) and liposomal doxorubicin on the developing
                  human fetus are unknown and there is the potential for teratogenic or
                  abortifacient effects. For this reason, women and men of child-bearing potential
                  must agree to use adequate contraception (hormonal or barrier method of birth
                  control; abstinence) prior to study entry, for the duration of study treatment,
                  and for 6 months after completion of peposertib (M3814) administration. Should a
                  woman become pregnant or suspect she is pregnant while she or her partner is
                  participating in this study, she should inform her treating physician
                  immediately. Because there is an unknown but potential risk for adverse events in
                  nursing infants secondary to treatment of the mother with peposertib (M3814),
                  breastfeeding should be discontinued if the mother is treated with peposertib
                  (M3814)

          -  Patients with a prior or concurrent malignancy whose natural history or treatment does
             not have the potential to interfere with the safety or efficacy assessment of the
             investigational regimen are eligible for this trial

          -  Patients with known history or current symptoms of cardiac disease, or history of
             treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
             function using the New York Heart Association Functional Classification. To be
             eligible for this trial, patients should be class 2B or better

          -  Ability to understand and the willingness to sign a written informed consent document.
             Participants with impaired decision-making capacity (IDMC) who have a
             legally-authorized representative (LAR) and/or family member available will also be
             eligible

          -  Archival formalin-fixed paraffin-embedded (FFPE) tissue collected within the past 36
             months prior to registration must be available for submission for deoxyribonucleic
             acid (DNA)/ribonucleic acid (RNA) analysis

        Exclusion Criteria:

          -  Patients are excluded from the dose-escalation phase of the study if they are eligible
             for any available therapies known to confer clinical benefit

          -  Inability to swallow and/or absorb oral medication (patients with a drainage peg are
             ineligible)

          -  Patients may not have received prior anthracyclines (doxorubicin or pegylated
             liposomal doxorubicin) for treatment of their ovarian cancer

          -  Patients who have not recovered from adverse events due to prior anti-cancer therapy
             (i.e., have residual toxicities > grade 1) with the exception of alopecia, thyroid
             dysfunction, or neuropathy

          -  Patients who are receiving any other investigational agents within 28 days prior to
             start of treatment

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to peposertib (M3814) or pegylated liposomal doxorubicin

          -  Patients who cannot discontinue concomitant medications or herbal supplements that are
             strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4/5 and
             CYP2C19. Concomitant use of CYP3A4/5 substrates with a narrow therapeutic index,
             potent CYP2D6 inhibitor/inducer, P-gp inhibitor, BCRP inhibitor, or potent CYP2C9
             inhibitor/inducers are also prohibited are also excluded and may not be taken when on
             study treatment. Patients may confer with the study doctor to determine if alternative
             medications can be used. The following categories of medications and herbal
             supplements must be discontinued for at least the specified period of time before the
             patient can be treated:

               -  Strong inducers of CYP3A4/5 and CYP2C19: >= 3 weeks prior to study treatment

               -  Strong inhibitors of CYP3A4/5 and CYP2C19: >=1 week prior to study treatment

               -  Substrates of CYP3A4/5 with a narrow therapeutic index: >=1 day prior to study
                  treatment

               -  Because the lists of these agents are constantly changing, it is important to
                  regularly consult a frequently-updated medical reference. As part of the
                  enrollment/informed consent procedures, the patient will be counseled on the risk
                  of interactions with other agents, and what to do if new medications need to be
                  prescribed or if the patient is considering a new over-the-counter medicine or
                  herbal product. Patient Drug Interactions Handout and Wallet Card should be
                  provided to patients

          -  Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs). Patients
             may confer with the study doctor to determine if such medications can be discontinued.
             These must be discontinued >= 5 days prior to study treatment. Patients do not need to
             discontinue calcium carbonate

          -  Patients receiving sorivudine or any chemically related analogues (such as brivudine)
             are excluded

          -  Patients who have received a live attenuated vaccine within 30 days of dosing with
             peposertib (M3814)

          -  Patients with uncontrolled intercurrent illness, including but not limited to ongoing
             or active infection

          -  Patients with psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because peposertib (M3814) is DNA-PK
             inhibitor agent with the potential for teratogenic or abortifacient effects. Because
             there is an unknown but potential risk for adverse events in nursing infants secondary
             to treatment of the mother with peposertib (M3814), breastfeeding should be
             discontinued if the mother is treated with peposertib (M3814). These potential risks
             may also apply to other agents used in this study

          -  Patients with significant (uncontrolled) cardiac conduction abnormalities are excluded
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rachel N Grisham, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04092270

Organization ID

NCI-2019-06123

Secondary IDs

NCI-2019-06123

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Rachel N Grisham, Principal Investigator, JHU Sidney Kimmel Comprehensive Cancer Center LAO


Verification Date

August 2021