Open-to-Accrual Therapeutic Trials - Phase III


Phase III

Protocol ID

Official Title

PI Name

Lead CRC

Disease Site

Phase

EA6141  ClinicalTrials.gov:   NCT02339571

Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma S. Ghamande Inquiries Melanoma II/III

NRG-GY009  ClinicalTrials.gov  NCT02839707

A Randomized, Phase II/III Study of Pegylated Lipsomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer S. Ghamande Melissa James Ovarian Cancer II/III

NRG-LU002 ClinicalTrials.gov:  NCT03137771

Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial S. Ghamande Kelly Adams Non-Small Cell Lung Cancer II/III

RTOG-1216  ClinicalTrials.gov:   NCT01810913

Randomized Phase II/III Trials of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Celuximab for High-Risk Squamous Cell Cancer of the Head and Neck S. Ghamande Inquiries Head and Neck Squamous Cell Cancer II/III

A011106  ClinicalTrials.gov:   NCT01953588

ALTernate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast Cancer NeoAdjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study S. Ghamande Inquiries Breast Cancer III

A011202  ClinicalTrials,gov:   NCT01901094

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3N1) Who have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy S. Ghamande Inquiries  Breast Cancer III

A051301  ClinicalTrials.gov:   NCT02443077

A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-cell Subtype S. Ghamande Inquiries Large C-Cell Lymphoma III

A081105 (ALCHEMIST)  ClinicalTrials.gov:   NCT02193282

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) S. Ghamande Inquiries Non-Small Cell Lung Cancer III

AHOD1331  ClinicalTrials.gov:   NCT02166463

A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents Protocol C. McDonough Robin Dobbins

Kimberly Gray
Classical Hodgkin Lymphoma III

AVA-CIT-330 ClinicalTrials.gov: NCT03471078

A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers Protocol Type: Interventional S. Ghamande Donna Wheatley Non-Hematological Cancers III

BGB-3111-305  ClinicalTrials.gov:  NCT03734016

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma L. Bryan Kelly Adams Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma III

BMT-CTN-1506  ClinicalTrials.gov:   NCT02997202

(2215-CL-0304) A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML J. Pantin Connie Edwards Acute Myeloid Leukemia III

CALGB-80702  ClinicalTrials,gov:   NCT01150045

A Phase III Trials of 6 Versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer S. Ghamande Kelly Adams Colon Cancer III

CLOVIS  ClinicalTrials.gov:   NCT02855944

A Phase 3 Milticenter, Open-label, Randomized Study of Rucaparib versus Weekly Paclitaxel in Patients with BRCA-like Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer S. Ghamande Donna Wheatley Ovarian, Fallopian Tube, or Primary Peritoneal Cancer III

EA4151  ClinicalTrials.gov:   NCT03267433

A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission S. Ghamande Sandra Wall  Mantle Cell Lymphoma III

E4512 (Alchemist)  ClinicalTrials.gov:   NCT02201992

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein S. Ghamande Inquiries  Non-Small Cell Lung Cancer III

EA5142  ClinicalTrials.gov:   NCT02595944

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers S. Ghamande Inquiries Non-Small Cell Lung Cancer III

EA6134  ClinicalTrials.gov:   NCT02224781

A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma S. Ghamande Inquiries Melanoma III

GOG-0213  ClinicalTrials.gov  NCT00565851

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912) Protocol S. Ghamande Inquiries Ovarian, Primary Peritoneal, and Fallopian Tube Cancer III

GOG-3020/CO-338-087 ClinicalTrials.gov:  NCT03522246

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy) S. Ghamande Melissa James Ovarian Cancer III

GOG-3025/DUO-O  ClinicalTrials.gov:  NCT03737643

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients S. Ghamande Melissa James Ovarian Cancer III

IDR-OM-02  ClinicalTrials.gov:  NCT03237325

A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck A. Guddati Kelly Adams Head and Neck Squamous Cell Cancer III

INCB-39110-309  ClinicalTrials.gov:  NCT03584516

A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease V. Kota Connie Edwards Chronic Graft-Versus-Host Disease III

MK3475-775  ClinicalTrials.gov  NCT03517449

A Multicenter, Open-Label, Randomized, Phase 3 Trial to compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab Versus Treatment of Physician's Choice in Participants with Advanced Endometrial Cancer S. Ghamande Donna Wheatley Endometrial Cancer III

NRG-BR003  ClinicalTrials.gov:   NCT02488967

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer S. Ghamande Inquiries Breast Cancer III

NSABP-B-51  ClinicalTrials.gov:   NCT01872975

A Randomized Phase III Clinical Trial Evaluating Post-Masectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy S. Ghamande Inquiries Breast Cancer III

NSABP-B-52  ClinicalTrials,gov:   NCT02003209

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation S. Ghamande Inquiries Breast Cancer  III

NSABP-B-55  ClinicalTrials.gov:   NCT02032823

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA 1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy S. Ghamande Inquiries Breast Cancer III

S1207  ClinicalTrials.gov:   NCT01674140

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy Plus or Minus One Year of Everolimus in Patients with High Risk, Hormone Receptor-Positive and Her2/neu Negative Breast Cancer S. Ghamande Inquiries Breast Cancer III

S1418  ClinicalTrials.gov#   NCT02954874

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 Chemotherapy S. Ghamande Sandra Wall Breast Cancer III

SOLO 3  ClinicalTrials.gov:   NCT02282020

A Phase III, Open Label, Randomized, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations  S. Ghamande Melissa James Ovarian Cancer III