Clinical Trials

Title Start Date Principal Name
[1005180-2] A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of DigiFab® in Antepartum Subjects with Severe Preeclampsia   Brian Brocato, D.O. 
[1031505-3] A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)   Moh'd Khushman, M.D. 
[1032154-1] Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer; S1513   Moh'd Khushman , MD 
[286271-13] AALL0932, Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)   Felicia Wilson, M.D. 
[289315-21] AAML1031, A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD   Felicia Wilson, M.D. 
[360626-14] AALL1131- A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B- ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Phlike Tyrosine Kinase Inhibitor (TKI) Sensitive Mutation   Felicia Wilson, M.D. 
[433957-19] Cardiovascular Inflammation Reduction Trial (CIRT): A randomized, double-blind, placebo-controlled, event-driven trial of weekly low-dose methotrexate (LDM) in the prevention of cardiovascular events among stable coronary artery disease patie   Ghazanfar Qureshi, M.D. 
[493322-9] A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial (ANZGOG 0902/GOG-0274/RTOG 1174)   Rodney Rocconi, M.D. 
[526659-9] A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant ChemotherapyWho Convert to Pathologically Nega   Weisi Yan, M.D. 
[527707-13] A Randomized, Double Blind, Multicenter, Parallel-Group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy   David Clarkson, M.D. 
[552027-11] ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study (Alliance A011106)   Donna L. Dyess, M.D. 
[556164-14] Androgen Deprivation Therapy and High Dose Radiotherapy with or without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial   Weisi Yan, M.D. 
[595286-17] A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study)   Carole Norden, M.D. 
[606906-11] A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma   Thomas Butler, M.D. 
[654939-10] Collection of Whole Blood Specimens from Pregnant Women at Increased Risk for Fetal Chromosomal Abnormality for use in Development of a Noninvasive Prenatal Test in Detection of the Relative Quantity of Chromosomal Material in Circulating Cel   Susan Baker, M.D. 
[677751-4] ANBL1232 Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma. A Groupwide Historically Controlled Phase III Study   Felicia Wilson, M.D. 
[752645-5] AEWS1221: Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma   Felicia Wilson, M.D. 
[794424-7] A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy   Donna L. Dyess, M.D. 
[794424] - A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy   Lynn Dyess M.D. 
[813731-4] A Randomized Double-Blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in Patients with Prelabor Premature Rupture of Membranes   Brian Brocato, D.O. 
[819237-6] A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mes   Moh'd Khushman, M.D. 
[824258-5] Protocol AALL1231 A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)   Felicia Wilson, M.D. 
[839470-3] A MultiCenter, Double Blind, Randomized, Single Dose, Active-Controlled Study To Investigate The Efficacy And Safety Of Synthetic Surfactant (CHF 5633) In Comparison To Porcine Surfactant (Poractant Alfa, Curosurf) In The Treatment Of Preterm   Fabien Eyal, M.D. 
[849584-12] A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in   William Taylor, M.D. 
[904698-2] Aerosol Delivery of Infasurf to Spontaneously Breathing RDS Patients   Fabien Eyal, M.D. 
[921786-3] PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growt   Carole Norden, M.D. 
[923977-5] Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)   Carole Norden, M.D. 
[940957-4] Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer - AIM2CERV   Jennifer Scalici, M.D. 
A phase 1B/2 multi-center, double-blind (principal investigators and study subjects blinded, sponsor unblinded), placebo-controlled, randomized, single-ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subje   Steve Cordina, M.D. 
A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethinedrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain 09/12/2017  Botros Rizk, MD 
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (NASH)   Phillip Henderson, D.O. 
A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Skin Structure Infections   Haidee Custodio,, MD 
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease (156-13-211) 11/11/2014  Michael Culpepper, MD 
A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer   Clayton Smith, , MD 
A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable PancreaticAdenocarcinoma   Marcus Tan, MD 
A Randomized Placebo Controlled Phase II Trial of Metformin in Conjunction with Chemotherapy Followed by Metformin Maintenance Therapy in Advanced Stage Ovarian, Fallopian Tube and Primary Peritoneal Cancer 09/12/2017  Rodney Rocconi, MD 
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo 01/10/2018  Lynn Dyess MD 
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL) - (CL-PT   Rodney Rocconi, M.D. 
A Randomized, Double-Blind, Placebo-Controlled study to Assess the Effects of Bempedoic Acid (ETC-1002) on the occurrence of Major Cardiovascular Events in Patients with, or at High Risk for Cardiovascular Disease who are Statin-Intolerant   Omar, Bassam, MD 
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency 07/21/2017  Christopher Malozzi, DO 
A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Pl   Moh'd Khushman, , MD 
A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemothera   Carole Norden, M.D. 
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation versus an FDA-approved Comparator in Adult Subjects prior to Colonoscopy 12/12/2017  Reynaldo Rodriguez D.O. 
A Single Arm Open-Label Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women with Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer 03/05/2018  Rodney Rocconi MD 
AAML1331 A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid A COG Groupwide Phase III Study 02/05/2018  Felicia Wilson, M.D. 
AGCT1531 A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors 01/02/2018  Felicia Wilson, M.D. 
AHEP0731 Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus (IND#122782, NSC#683864) Added to High Risk Stratum Treatment A Phase III Study, An Intergroup Study for Participation by COG and the Japanese Study Group for Pediatric   Felicia L. Wilson, , M.D. 
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Therapy of Investigator's Choice Chemotherapy in Recurrent or Metastatic Platinum-Refractory Cervical Carcinoma 08/11/2017  Rodney Rocconi, MD 
CO39722 A Phase III, Open-Label, Multicenter, Two-Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizuman in Patients with Previously Untreated Advanced BRAF V600 Wild-Type Melanoma 08/31/2017  Arthur Frankel MD 
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients   Fabien Eyal, , MD 
CX-1158-101 Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor CB-1158 as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid Tumors 08/17/2017  Sachin Pai, MD 
DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors   Sachin Pai, MD 
EA1131: EA1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy 09/08/2015  Carole Norden, MD 
Neuroform Atlas Stent System 01/04/2018  Steve Cordina, M.D. 
NRG-HN004: Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin 01/24/2018  Sachin Pai, M.D. 
NRG-LU002; Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial   Weisi Yan, M.D. 
NRG-LU002; Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial   Weisi Yan, MD 
Phase II study of pembrolizumab and ipilimumab following initial anti-PD1/L1 antibody 12/27/2017  Arthur Frankel, M.D. 
Phase iii open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of stratagraft® skin tissue in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns 09/12/2017  Steven Kahn, MD 
Pilot, prospective, randomized, controlled, multicenter, technical feasibility clinical study comparing standard anastomosis closure technique to standard closure techniques plus Sylys Surgical Sealant   Paul Rider, MD 
Preoperative Extended Chemotherapy Vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas   Moh'd Khushman, , MD 
Prospective Evaluation of the ReCell Autologous Cell Harvesting Device for Specific Compassionate use cases   Steven Kahn, MD 
Randomized, Open-label, Phase 3 Trial of Nivolumab plus Brentuximab vedotin versus Brentuximab vedotin alone in Participants with Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma   Thaddeus Beeker MD 

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