Clinical trials: sponsored by UNC Lineberger Comprehensive Cancer Center
Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma
- Trial name
- NCT04564989
- Where
- 3 sites in United States
- Volunteers
- 220 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer
This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-Negative Breast Carcinoma, Node-positive Breast Cancer
- Trial name
- P-RAD(+)TN-DCT (NCT07276880)
- Testing
- Neoadjuvant Pembrolizumab, low dose neoadjuvant boost, High dose neoadjuvant boost
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer
Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel
This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe…
- Conditions
- Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Basal Cell Neoplasm
- Trial name
- PANGEA (NCT06483555)
- Testing
- Gemcitabine, Nab paclitaxel, Erlotinib
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Thoracic Neoplasms, Lumbar Neoplasm
Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors
This study looks at how well a combination of treatments helps reduce pain in people with tumors in the middle and lower back (thoracic and lumbar spine).
- Trial name
- NCT07479199
- Testing
- kyphoplasty with Osteocool
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Squamous Cell Lung Cancer, Squamous Non-small Cell Lung Cancer
Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab
This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with…
- Conditions
- Squamous Cell Lung Cancer, Squamous Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- PANDA-VAC (NCT04266730)
- Testing
- PANDA-VAC, Pembrolizumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer, Residual Disease
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional…
- Conditions
- Breast Cancer, Residual Disease, Triple Negative Breast Cancer (TNBC), Stage II/III
- Trial name
- PREDICT-RD (NCT07069595)
- Testing
- Datopotamab deruxtecan, Circulating tumor DNA (ctDNA) testing
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Glioblastoma Multiforme
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma.
- Trial name
- NCT05366179
- Testing
- CAR.B7-H3T cells infusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Human Papilloma Virus
Impact of Standing Orders Optimization
This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training.
- Trial name
- NCT05742386
- Testing
- Communication training, Communication training enhanced with standing orders optimization
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Relapsed Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma
LCCC1852-ATL is a prospective 2-arm study designed to determine if chimeric antigen receptor T (CAR-T) cells result in immunomodulation which can be subsequently exploited by programmed cell death protein 1 (PD-1) antibodies to…
- Trial name
- NCT04134325
- Testing
- Nivolumab, Pembrolizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Diffuse Large B-cell Lymphoma
Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma
This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma…
- Trial name
- NCT05498220
- Testing
- Polatuzumab vedotin (PV), Rituximab, Hyaluronidase
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Sarcoma, Gastrointestinal Cancer
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care…
- Trial name
- NCT05743426
- Testing
- Survey, Toxicity Assessments
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Neuroblastoma, Osteosarcoma
Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells.
- Trial name
- NCT03721068
- Testing
- iC9.GD2.CAR.IL-15 T-cells, Cyclophosphamide, Fludarabine
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Melanoma Stage Iii, Melanoma Stage Iv
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
This is a multicenter open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-Programmed death-1 or Programmed death ligand 1…
- Conditions
- Melanoma Stage Iii, Melanoma Stage Iv, Melanoma, Melanoma (Skin)
- Trial name
- NCT03620019
- Testing
- Denosumab, Pembrolizumab, Nivolumab
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Bladder Cancer
Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy
The purpose of this study is to evaluate whether adding pembrolizumab (Keytruda) to the combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a cystectomy, for people with muscle-invasive…
- Trial name
- NCT02690558
- Testing
- pembrolizumab, gemcitabine and cisplatin
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck
Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery
The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the…
- Trial name
- NCT01612351
- Testing
- Carboplatin, Paclitaxel, Lapatinib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer
Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life…
- Trial name
- NCT05926024
- Testing
- Exercise Recall Patient Reported Outcomes, Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes, Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Cancer of the Colon, Colon Cancer
Palbociclib and Cetuximab in Metastatic Colorectal Cancer
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer.
- Conditions
- Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer
- Trial name
- NCT03446157
- Testing
- Cetuximab, Palbociclib
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Human Papilloma Virus
Engaging Clinical Champions to Improve HPV Vaccination
This trial will compare two ways to improve communication about HPV vaccination in primary care. The research team will work with primary care clinics. Some clinics will receive communication training from an outside expert.
- Trial name
- NCT05736718
- Testing
- Champion Announcement Approach Training, Traditional Announcement Approach Training
- Where
- 2 sites in United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Carcinoma, Squamous Cell, Oral Cancer
Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma
Participants in this study have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This is called locally-advanced SCCHN.
- Conditions
- Carcinoma, Squamous Cell, Oral Cancer, Oropharynx Cancer, Larynx Cancer
- Trial name
- NCT03174275
- Testing
- Durvalumab, Carboplatin, Nab-paclitaxel
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Cancer, Malignant Tumor
Rehabilitation Outcomes Study
This pilot health services interventional study aims to prospectively assess the effectiveness of a pre-treatment rehabilitation (prehabilitation) program across a diverse cohort of adult cancer patients via a randomized pilot…
- Trial name
- NCT06674889
- Testing
- Rehabilitation-based intervention
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center