RecruitingInterventional · Phase 2NCT04143724 ↗A Phase 2a Study to Evaluate the Safety and Pharmacokinetics of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-ThalassemiaSujit ShethPIInterventionDrug: ACE-536DatesNov 2019 – Jan 2028 (est.)
Active, not recruitingInterventional · Phase 2/3NCT04150068 ↗A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug ResistanceSorana Segal-MaurerPIInterventionDrug: Oral Lenacapavir · Drug: Oral Lenacapavir Placebo · Drug: Subcutaneous Lenacapavir · Drug: Failing ARV Regimen · Drug: Optimized Background Regimen (OBR)DatesNov 2019 – Oct 2020· Results postedSponsorGilead Sciences, Inc.HIV-1-infection
RecruitingInterventional · Phase 1/2NCT04150497 ↗Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)Gail J RobozPIInterventionBiological: UCART22 · Biological: CLLS52DatesOct 2019 – Jun 2026 (est.)SponsorCellectis, IncB-cell Acute Lymphoblastic Leukemia
Active, not recruitingInterventional · Phase 1NCT04150887 ↗An Open-label, Multicenter, Phase 1b Study of OV-1001 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid LeukemiaGail J RobozPIInterventionDrug: Cusatuzumab · Drug: Azacitidine · Drug: VenetoclaxDatesDec 2019 – May 2027 (est.)SponsorJanssen Research & Development, LLCLeukemia, Myeloid, Acute
Active, not recruitingInterventional · Not applicableNCT04153292 ↗SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal AccessShmuel ChenPIInterventionDevice: SAPIEN M3 valve and dockDatesNov 2020 – Oct 2027 (est.)SponsorEdwards Lifesciences Corp.Mitral RegurgitationMitral Valve Insufficiency
Active, not recruitingInterventional · Phase 2NCT04164082 ↗Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder CancerCora SternbergPIInterventionProcedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Cystoscopy · Drug: Gemcitabine Hydrochloride · Procedure: Magnetic Resonance Imaging · Biological: Pembrolizumab · Procedure: Transurethral Resection of Bladder TumorDatesMar 2020 – Dec 2026 (est.)SponsorAlliance for Clinical Trials in OncologyBladder Flat Urothelial Carcinoma In SituNon-Muscle Invasive Bladder Urothelial CarcinomaStage 0a Bladder Cancer AJCC v8+2 more
RecruitingInterventional · Phase 1NCT04167969 ↗Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica NanoparticlesMichelle S. BradburyPIInterventionDrug: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer · Diagnostic test: PET/MRI/fluorescence imaging · Other: Blood and urine sampling · Procedure: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection · Drug: 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dotsDatesFeb 2021 – Nov 2027 (est.)SponsorMemorial Sloan Kettering Cancer CenterProstate Cancer
Active, not recruitingInterventional · Phase 1/2NCT04172532 ↗A Phase 1/2 Study of M3814 (Peposertib) in Combination With Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic AdenocarcinomaAllyson J OceanPIInterventionProcedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Radiation: Hypofractionated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Drug: Peposertib · Other: Placebo AdministrationDatesJan 2021 – Aug 2027 (est.)SponsorNational Cancer InstituteLocally Advanced Pancreatic AdenocarcinomaStage III Pancreatic Cancer AJCC v8
Active, not recruitingInterventional · Phase 3NCT04175210 ↗Prospective Randomized Study of Accelerated Radiation Therapy (PRART) : A Non-Inferiority Trial to Compare Breast Cosmesis and Local Control After Concomitant Boost Breast Radiotherapy With Fifteen Fractions in Three Weeks (Arm 1, Standard) Versus Ten Fractions in Two Weeks (Arm 2, Experimental)Silvia Chiara FormentiPIInterventionRadiation: Radiation therapy - 3 weeks · Radiation: Radiation therapy - 2 weeksDatesNov 2019 – Jul 2025· Results postedSponsorWeill Medical College of Cornell UniversityBreast Cancer
RecruitingInterventional · Phase 1/2NCT04176198 ↗A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary MyelofibrosisJoseph M ScanduraPIInterventionDrug: Nusivertib · Drug: Ruxolitinib · Drug: MomelotinibDatesDec 2019 – Apr 2027 (est.)SponsorSumitomo Dainippon Pharma Oncology, IncMyelofibrosis
Active, not recruitingInterventional · Phase 1NCT04190862 ↗An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal FistulasJeffrey W MilsomPIInterventionDrug: E-CEL UVECDatesJan 2020 – Dec 2026 (est.)SponsorWeill Medical College of Cornell UniversityAnal Fistula
Active, not recruitingInterventional · Not applicableNCT04192591 ↗A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)Neel MehtaPIInterventionDevice: Superion™ IDS deviceDatesJan 2020 – Feb 2038 (est.)SponsorBoston Scientific CorporationLumbar Spinal Stenosis
Active, not recruitingInterventional · Phase 1/2NCT04194554 ↗A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate CancerScott T. TagawaPIInterventionDrug: Niraparib · Drug: Leuprolide · Drug: Abiraterone Acetate · Radiation: Stereotactic body radiotherapy (SBRT)DatesNov 2020 – May 2027 (est.)SponsorUniversity of MichiganProstate Cancer
RecruitingInterventional · Not applicableNCT04197921 ↗A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Abuse Disorders (SUDs)Michael G KaplittPIInterventionDevice: Exablate Model 4000 Type 2.0/2.1DatesNov 2019 – Dec 2026 (est.)SponsorInSightecOpioid-use DisorderSubstance Use Disorders
Active, not recruitingInterventional · Phase 3NCT04199689 ↗A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of AgeGrant EllsworthPIInterventionBiological: 9vHPV Vaccine · Other: Placebo (Saline for Injection)DatesFeb 2020 – Jan 2027 (est.)SponsorMerck Sharp & Dohme CorpPapillomavirus Infections
Active, not recruitingInterventional · Phase 3NCT04214067 ↗A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial CancerEvelyn CantilloPIInterventionProcedure: Biospecimen Collection · Radiation: Brachytherapy · Procedure: Computed Tomography · Radiation: External Beam Radiation Therapy · Procedure: Magnetic Resonance Imaging · Biological: Pembrolizumab · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: X-Ray ImagingDatesApr 2020 – Dec 2025SponsorNRG OncologyEndometrial Endometrioid AdenocarcinomaStage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Active, not recruitingInterventional · Phase 3NCT04214262 ↗A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLCHani Lamie AshamallaPIInterventionDrug: Atezolizumab · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Fludeoxyglucose F-18 · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Body Radiation TherapyDatesAug 2020 – Aug 2024· Results postedSponsorSWOG Cancer Research NetworkLung Non-Small Cell CarcinomaStage I Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8
RecruitingInterventional · Phase 2NCT04220476 ↗CIMER: Combined Immunotherapies in Metastatic ER+ Breast CancerSilvia Chiara FormentiPIInterventionRadiation: Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions) · Drug: Letrozole 2.5Mg Tab · Drug: Palbociclib 125mgDatesMar 2020 – Dec 2025 (est.)SponsorWeill Medical College of Cornell UniversityBreast Cancer
Active, not recruitingInterventional · Phase 3NCT04224493 ↗Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular LymphomaErin MulveyPIInterventionDrug: Tazemetostat · Drug: Placebo oral tablet · Combination product: Lenalidomide · Combination product: RituximabDatesJun 2020 – Feb 2027 (est.)SponsorEpizymeRelapsed/Refractory Follicular LymphomaFollicular LymphomaRefractory Follicular Lymphoma
Active, not recruitingInterventional · Not applicableNCT04226547 ↗Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral AnticoagulantsGeoffrey W BergmanPIInterventionDevice: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) · Drug: Non-Vitamin K Oral AntagonistsDatesJul 2020 – Jan 2029 (est.)SponsorAbbott Cardiovascular Systems, Inc.Atrial FibrillationStrokeBleeding