Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn
The primary objectives are as follows:
 To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of AGEN1884 in subjects with advanced or metastatic cancer (solid tumors or lymphoma) including but not limited to carcinoma, sarcoma, malignant glioma, or melanoma.
 To determine the maximum tolerated dose (MTD).
 To evaluate the pharmacokinetics (PK) of AGEN1884 in subjects with advanced or
metastatic solid tumors.
Hwang, Jimmy John
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun
The primary objective of this trial is to establish statistical equivalence in terms of efficacy (overall response rate (ORR), proportion of patients with Complete Response (CR) plus Partial Response (PR) until 18 weeks of first-line treatemnt with BI 695502 plus chemotherapy versus Avastin plus chmeotherapy, followed by maintenance therapy. Kim, Edward Sanghyun
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim
To evaluate progression free survival (PFS) with nab-paclitaxel as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin in subjects with squamous cell NSCLC. Mileham, Kathryn Finch
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam
The primary objective of this study is to evaluate the safety and tolerability of LY2835219 when administered orally in combination with multiple single-agent options to patients with Stage IV non-small cell lung cancer (NSCLC) using Common Terminology Criteria for Adverse Events (CTCAE version 4.0, NCI 2009). The secondary objectives of the study are to determine the pharmacokinetics (PK) of LY2835219 when given in combination with multiple single-agent options; to document the antitumor activ Kim, Edward Sanghyun
Primary:
To assess the response rate of the combination of carboplatin and abraxane in patients with advanced non-small cell lung cancer (NSCLC).
Secondary:
To assess the disease control rate, duration of response, duration of disease control, overall survival, progression-free survival, and the safety and toxicity profile with this regimen.
Exploratory:
To assess broad molecular profiling.
Mileham, Kathryn Finch
Lung Cancer Biomarker Testing in Liquid and Tissue Biopsies Ersek, Jennifer L
The primary objectives of this study are to: (1) Identify extrinsic and intrinsic factors and motivators associated with a patient?s decision to initiate or continue maintenance therapy or their decision to decline maintenance therapy;(2) Describe patient perceptions regarding the extent of shared decision making around maintenance therapy; (3) Identify patients? expectations of maintenance therapy; and (4) Identify barriers to maintenance therapy from the patient perspective. Kim, Edward Sanghyun
Part A Objective:
The primary objective of Part A is to assess the safety and tolerability of ramucirumab when administered in
combination with erlotinib as therapy in previously untreated patients with EGFR mutation-positive metastatic
NSCLC.
Part B:
Primary Objectives:
The primary objective of Part B is to compare PFS of ramucirumab administered in combination with erlotinib versus
placebo in combination with erlotinib as therapy in previously untreated patients with EGFR mutation-posit
Mileham, Kathryn Finch
Objectives Endpoints
Phase 1a
and 1b
Primary: To assess the safety and tolerability of ramucirumab in combination with MEDI4736 Dose-limiting toxicities, observed for 1 treatment cycle (21 days for NSCLC and 28 days for Gastric-GEJ and HCC) Safety (including but not limited to):
TEAEs, SAEs, deaths, and clinical laboratory abnormalities per CTCAE (Version 4.0)
Secondary: To assess the PK of ramucirumab and MEDI4736 when co-administered
PK: Cmin and approximate Cmax of ramucirumab and MEDI
Hwang, Jimmy John
This registry is intended to measure the effect of myPlan Lung Cancer? test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC.

Mileham, Kathryn Finch
To evaluate the efficacy of atezolizumab plus carboplatin plus etoposide compared with placebo plus carboplatin plus etoposide in the ITT population as measured by investigator assessed PFS according to RECIST v1.1.

Induru, Raghava Reddy
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