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A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Pembrolizumab in Adult Participants With Resectable Stage 3 or 4 Melanoma
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. These types of study drug are collectively known as immune checkpoint inhibitors. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab as peri-operative therapy in participants...
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Autologous T Cells Lentivirally Transduced to Express L1CAM-Specific Chimeric Antigen Receptors in Treating Patients With Locally Advanced and Unresectable or Metastatic Small Cell Neuroendocrine Prostate Cancer
This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ lentivirally transduced to express L1CAM-specific chimeric antigen receptor (CAR) and EGFRt mutation specific T cells and to see how well they work in treating patients with small cell neuroendocrine prostate cancer (SCNPC) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in...
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A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma
This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation.
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AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM
This is a multi-center, double-blind, 2:1 randomized phase III trial to determine whether the addition of AV-GBM-1, a therapeutic, patient-specific dendritic cell vaccine, to standard therapy increases OS of patients with a recent diagnosis of primary GBM. The intent is to enroll approximately 726 patients for tumor collection to enroll 690 who are eligible for treatment at the time of randomization and who have granted consent for participation. Because of the lack of toxicity, there are no restrictions related to performance status or blood tests at the time of treatment. The key endpoint is OS from date of first injection after...
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A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases
The purpose of this study is to determine if the study drug, patritumab deruxtecan (HER3-DXd), can be measured in brain tumor tissue after recieving one dose of patritumab deruxtecan before surgery.
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Azoles Targeting Recurrent High Grade Gliomas
High-grade gliomas are the most common and aggressive type of brain cancer. Scientists don't fully understand how they grow and spread, and treatments haven't improved much in recent years. However, it's been discovered that these cancers rely heavily on using glucose to maintain their cancerous traits. In lab tests, drugs from the azole class, which target a key step in glucose metabolism, have shown promise in reducing tumor growth in these cancers. Researchers now want to test two of these drugs, ketoconazole and posaconazole, in patients with recurring high-grade gliomas. A small group of these patients will receive either one or ...
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B-amyloid as a Marker for GBM Bioimaging
This project is aimed at improvement of glioblastoma (GBM) diagnostic strategies for discrimination of tumor progression and chemo- and radiotherapeutic treatment-related changes in brain tissue. The study will elucidate the diagnostic value of PET imaging with use of amyloid-β radioisotope tracer Amyvid (Florbetapir F18) for GBM. The results of the study will provide data for development of new approach for GBM diagnostics.
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Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
This is a single center non-randomized, single-arm feasibility trial of the implementation of virtual behavioral health counseling sessions alongside standard-of-care treatment.
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Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).
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Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
This trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. Patients who are considered eligible for GBM resection or biopsy will be included. Through shared-decision making patients and their treating physicians will decide upon resection or biopsy. Written informed consent will be obtained. Participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival. Follow-up will consist of health-related quality...