Clinical Trials

Alternate approaches for clinical stage II or III Estrogen Receptor positive breast cancer Neoadjuvant Treatment (ALTERNATE) in postmenopausal women: a Phase III Study

Disease/Site: Breast
Protocol Number: Alliance A011106
Phase: III

PI/Coordinator: Dr. Mahvish Muzaffar/ Renee Coghill
Open Date: 10/19/2015
Contact Information: 252-744-5723

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Position Sentinel Lymph Node Disease after Neoadjuvant Chemotherapy

Disease/Site: Breast
Protocol Number: Alliance A011202
Phase: III

PI/Coordinator: Dr. Mahvish Muzaffar/ Renee Coghill
Open Date: 5/4/2015
Contact Information: 252-744-5723

IDEA (Individualized Decisions for Endocrine Therapy Alone): A prospective, single arm cohort study of patients receiving endocrine therapy alone (without radiotherapy) after breast conserving surgery for early-stage, post menopausal breast cancer patients whose tumors have favorable biologic features

Disease/Site: Breast
Protocol Number: IDEA
Phase: NA

PI/Coordinator: Dr. Mahvish Muzaffar/ Renee Coghill
Open Date: 3/23/2015
Contact Information: 252-744-5723

Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs Placebo in Combination With Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)

Disease/Site: Breast
Protocol Number: ONT-380-206
Phase: II

PI/Coordinator: Dr. Mahvish Muzaffar/ Renee Coghill
Open Date: 12/19/2016
Contact Information: 252-744-5723

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

Disease/Site: Breast
Protocol Number: NRG-BR003
Phase: III

PI/Coordinator: Dr. Mahvish Muzaffar/ Renee Coghill
Open Date: 4/4/2016
Contact Information: 252-744-5723

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall 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

Disease/Site: Breast
Protocol Number: NSABP B-51
Phase: III

PI/Coordinator: Dr. Mahvish Muzaffar/ Renee Coghill
Open Date: 3/5/2015
Contact Information: 252-744-5723

A Disease Registry for Patients with Chronic Lymphocytic Leukemia

Disease/Site: CLL
Protocol Number: informCLL
Phase:

PI/Coordinator: Dr. Darla Liles/Bolaji Babatunde
Open Date: 2/2/2017
Contact Information: 252-744-0320

The Myelodysplastic Syndromes (MDS) and AML Registry

Disease/Site: AML & MDS
Protocol Number: Connect
Phase: NA

PI/Coordinator: Dr. Darla Liles/ Denise Brigham
Open Date: 11/18/2015
Contact Information: 252-744-4924

PIPER: A Prospective, Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components

Disease/Site: Hematology/ Oncology
Protocol Number: PIPER
Phase: IV

PI/Coordinator: Dr. Darla Liles/Kaitlyn Walker
Open Date: 10/10/2016
Contact Information: 252-744-0456

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST – Genotype Screening component)

Disease/Site: Lung
Protocol Number: Alliance A151216 (ALCHEMIST)
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 7/30/2015
Contact Information: 252-744-1015

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completed Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Disease/Site: Lung
Protocol Number: Alliance A081105 (ALCHEMIST)
Phase: II

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 7/30/2015
Contact Information: 252-744-1015

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

Disease/Site: Lung
Protocol Number: ECOG-Acrin E4512 (ALCHEMIST)
Phase: III

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 7/30/2015
Contact Information: 252-744-1015

Phase II trial regarding the effect of comprehensive symptom management on inflammation and survival in metastatic lung cancer

Disease/Site: Lung
Protocol Number: INSYNC
Phase: -

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 9/24/2014
Contact Information: 252-744-1015

A Phase II Study of Definitive Concurrent Radiation Therapy with Cisplatin and Irinotecan Chemotherapy in Locally Advanced In-Operable Non-Small Cell Lung Cancer

Disease/Site: Lung
Protocol Number: LJCC 2014-01
Phase: II

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 10/16/2014
Contact Information: 252-744-1015

Predictive value of the modified glasgow prognostic score among patients undergoing immunotherapy with PD-1 targeted agents

Disease/Site: Lung
Protocol Number: P-MAIT
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/Amanda Brunni
Open Date: 11/11/2015
Contact Information: 252-744-5687

SNAP: Prognostic Value of the Modified Glasgow Prognostic Score In A North American Population of Thoracic Oncology Patients

Disease/Site: Lung
Protocol Number: SNAP
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/Amanda Brunni
Open Date: 10/20/2015
Contact Information: 252-744-5687

BDX-00146: An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer

Disease/Site: Lung
Protocol Number: BDX-00146
Phase:

PI/Coordinator: Dr. Paul R. Walker/Kaitlyn Walker
Open Date: 10/3/2016
Contact Information: 252-744-0456

Trends of Circulating Tumor DNA Levels in Patients Treated with Immune Therapy

Disease/Site: Lung
Protocol Number: CLIP-IT
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/Amanda Brunni
Open Date: 4/10/2017
Contact Information: 252-744-5687

Identification of Biomarkers in Lung Cancer Patients Treated with Immunotherapy

Disease/Site: Lung
Protocol Number: Yang
Phase: NA

PI/Coordinator: Dr. Li Yang/Amanda Brunni
Open Date: 8/30/2016
Contact Information: 252-744-5687

Carolina Senior: UNC Registry For Older Patients

Disease/Site: Cancer Registry
Protocol Number: LCCC0916
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/Any Available
Open Date: 7/23/2013
Contact Information: 252-744-1015

A Phase II, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Disease/Site: AIHA
Protocol Number: C-935788-053
Phase: II

PI/Coordinator: Dr. Darla Liles/ Amanda Wetherington
Open Date: 5/27/2016
Contact Information: 252-744-0320

AFT-25-Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial

Disease/Site: Breast
Protocol Number: COMET
Phase: III

PI/Coordinator: Dr. Jan Wong/Renee Coghill
Open Date: 07/10/2017
Contact Information: 252-744-5712

Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-interventional Study

Disease/Site: Breast
Protocol Number: POLARIS
Phase: NA

PI/Coordinator: Dr. Mahvish Muzaffar/Renee Coghill
Open Date: 07/10/2017
Contact Information: 252-744-5723

Studying Interventions for Managing Patients with Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-year Prospective Cohort Study (Simplicity)

Disease/Site: CML
Protocol Number: SIMPLICITY
Phase: NA

PI/Coordinator: Dr. Darla Liles/Bolaji Babatunde
Open Date: 06/01/2018
Contact Information: 252-744-0320

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects 18 years of age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutatoin

Disease/Site: AML
Protocol Number: AG120-C-009
Phase: III

PI/Coordinator: Dr. Darla Liles/Denise Brigham
Open Date: 08/23/2017
Contact Information: 252-744-4924

A Phase II, Randomized, Biomarker-driven, Clinical Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML

Disease/Site: AML
Protocol Number: TOLERO
Phase: II

PI/Coordinator: Dr. Darla Liles/Denise Brigham
Open Date: 11/14/2018
Contact Information: 252-744-4924

OP-103 OCEAN: A Randomized, Controlled, Open-Label, Phase III Study of Melflufen/Dexamethasone Compared with Pomalidomide/Dexamethasone for Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Lenalidomide.

Disease/Site: Multiple Myeloma
Protocol Number: OP-103
Phase: III

PI/Coordinator: Dr. Darla Liles/Denise Brigham
Open Date: 10/25/2017
Contact Information: 252-744-4924

BMS CA209-812: Randomized, Open-Label, Phase III 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 (CheckMate 812: CHECKpoint Pathway and NivoluMAb Clinical Trial Evaluation 812)

Disease/Site: Hodgkin's Lymphoma
Protocol Number: BMS CA209-812
Phase: III

PI/Coordinator: Dr. Darla Liles/Denise Brigham
Open Date: 12/06/2017
Contact Information: 252-744-4924

AFT-28: Direct Oral Anticoagulants (DOACS) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

Disease/Site: NA
Protocol Number: CANVAS
Phase: NA

PI/Coordinator: Dr. Darla Liles/Denise Brigham
Open Date: 09/15/2017
Contact Information: 252-744-4924

Smoking Cessation Prior to Surgery to Reduce Surgical Complications

Disease/Site: Lung
Protocol Number: A211401
Phase: III

PI/Coordinator: Dr. Jim Speicher/Amanda Brunni
Open Date: 10/4/2017
Contact Information: 252-744-5687

A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)

Disease/Site: Lung
Protocol Number: M16-298
Phase: III

PI/Coordinator: Dr. Paul R. Walker/Amanda Brunni
Open Date: 06/28/2017
Contact Information: 252-744-5687

Biomarkers of Immunotherapy Related Thromboembolic Events

Disease/Site: Lung
Protocol Number: NA
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/Amanda Brunni
Open Date: 03/07/2018
Contact Information: 252-744-5687

Trans(Intra)-Arterial Gemcitabine vs. Continuation of IV Gemcitabine and Nab-Paclitaxel following Radiotherapy for Locally Advanced Pancreatic Cancer

Disease/Site: Pancreas
Protocol Number: TIGeR-Pac
Phase: NA

PI/Coordinator: Dr. Emmanuel Zervos/Kaitlyn Walker
Open Date: 3/28/2016
Contact Information: 252-744-0456

Feasibility Trial for Treatment of Resectable Pancreatic Cancer with the Permanently Implantable LDR CivaSheet.

Disease/Site: Pancreas
Protocol Number: CT005
Phase: NA

PI/Coordinator: Dr. Emmanuel Zervos/Amanda Brunni
Open Date: 3/28/2016
Contact Information: 252-744-5687

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