Fredericksburg

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) at 1% or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments' impact.

This research focuses on women diagnosed with early stage breast cancer who typically receive lumpectomy followed by radiation therapy. The study evaluates a technique called Permanent Breast Seed Implant (PBSI), which delivers radiation to a portion of the breast where cancer is more likely to recur, rather than to the whole breast. PBSI aims to reduce the side effects associated with whole breast radiation, such as skin burns and prolonged treatment times, by using permanently implanted radioactive seeds. The PBSI procedure is done on an outpatient basis under local anesthesia and light sedation, after the surgery when the scar has healed and final pathology is available. It involves inserting stranded radioactive seeds into the target breast tissue guided by imaging, delivering low dose rate radiation over time. This method contrasts with traditional whole breast radiation that requires daily treatments over several weeks. The study collects data from multiple centers to ensure proper clinician training and to evaluate long-term safety and rare complications. Participants will be monitored for up to 10 years after the implant procedure with assessments including serious adverse events, breast cancer recurrence, side effects of PBSI, cosmetic outcomes, and survival status. Follow-up includes imaging, clinical evaluations, and quality assurance measures. This long-term data collection helps researchers understand the safety and effects of PBSI when performed by various practitioners across different centers.

Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are investigating the efficacy and safety of golcadomide combined with rituximab compared to investigator's choice treatments in adults with relapsed or refractory follicular lymphoma who have received at least one prior systemic therapy. This multicenter, randomized, open-label Phase 3 study focuses on participants with confirmed follicular lymphoma that has returned or not responded to previous treatments, aiming to better understand treatment options in this setting. Participants will be randomly assigned to receive either golcadomide plus rituximab or one of the investigator's chosen regimens, which may include rituximab combined with lenalidomide, R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone), or rituximab with bendamustine. Each treatment involves specified doses on specified days, and the study compares these approaches over a treatment period. During the study, participants will be closely monitored through evaluations such as imaging scans, pathology reviews, and quality of life questionnaires. Researchers will assess progression-free survival up to approximately 32 months, along with other measures like overall response rate, overall survival, duration of response, and minimal residual disease status. Safety and treatment effects will be tracked, and participants may be followed for up to nearly seven years to gather comprehensive outcome data.

Researchers are evaluating the safety and effectiveness of two different drug combinations for people with relapsed or refractory multiple myeloma (RRMM) who have had between one and three prior treatments and prior exposure to lenalidomide. The trial compares mezigdomide combined with bortezomib and dexamethasone (MeziVd) against pomalidomide combined with bortezomib and dexamethasone (PVd). This phase 3 study aims to understand which treatment better controls the disease and improves patient outcomes. Participants are randomly assigned to receive either the MeziVd or PVd treatment. Each drug is given at specified doses on certain days, though exact schedules are not detailed here. The study is open-label, meaning both participants and researchers know which treatment is being given. The trial includes multiple centers and continues over a period that may last up to about five years. During the study, participants will be closely monitored through various assessments including measurements of disease progression and survival. Researchers will track progression-free survival, overall response, duration of response, and quality of life among other outcomes. Safety is assessed by monitoring adverse events throughout the study. Participation involves regular visits for treatment and evaluations, and the study may last several years depending on individual patient progress and follow-up.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors (ICIs). The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are studying muvalaplin to see if it can reduce the risk of major heart problems in adults with high levels of lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. This Phase 3 trial is designed to provide strong evidence by comparing muvalaplin to a placebo in a large group of participants over several years. The study is sponsored by Eli Lilly and Company and focuses on adults with atherosclerotic cardiovascular disease or those at risk for it. Participants will be randomly assigned to receive either muvalaplin or a placebo, both taken by mouth. The trial is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. The study will last about 5.25 years, during which participants will be monitored closely. The primary goal is to measure the time until the first major adverse cardiac event occurs, including heart attacks and strokes. During the study, participants will have regular visits for assessments, including blood tests to measure lipoprotein(a) levels and pharmacokinetics of muvalaplin over the first 96 weeks. Researchers will track the occurrence of cardiovascular events, deaths, and healthcare resource use annually. Safety and adherence will be monitored throughout the study to ensure participant well-being and accurate data collection.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.