Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
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
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
Incidence of adverse events (AEs) in anaphylactic reaction SMQ (Standard Medical Dictionary for Regulatory Activities Queries). Amin, Asim
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 purpose of this study is to classify patients with renal tumors by histological categorization, surgicopathological stage, presence of metastases, age at diagnosis, tumor weight and loss of heterozygosity for chromosomes 1p and 16q, to thereby define eligibility for a series of therapeutic studies. Kaplan, Joel Adam
Disease free survival (DFS) from baseline until first occurrence of DFS event.

Burgess, Earle Frederick
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review

To evaluate and compare OS in subjects treated with pembrolizumab plus
axitinib versus sunitinib monotherapy.
Amin, Asim
To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1
positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy; (b) Pembrolizumab versus chemotherapy
Burgess, Earle Frederick
The purpose of this registry is to collect information on patients who are receiving treatment with Proleukin in an organized way, and to learn more about patient care during and after treatment. Amin, Asim
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