Tappahannock

Researchers are conducting a multi-center, open-label, randomized clinical trial to compare survival outcomes between robotic-assisted laparoscopy and open surgery for patients with early stage cervical cancer. The study tests whether robotically assisted hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy regarding disease-free survival. Patients must have specific cancer types and stages without evidence of metastases to participate. Participants will be randomly assigned to either the robotic surgery group or the open surgery group. In the robotic arm, hysterectomy is performed using a minimally invasive robotic device with specific surgical protocols to close the vagina prior to colpotomy. In the standard arm, an open radical or simple hysterectomy is performed with vaginal closure over the tumor before colpotomy. Both groups may have ovary removal or preservation, and detailed surgical records are maintained. During the study, patients undergo preoperative assessments including imaging and lab tests, and pregnancy tests for pre-menopausal women. Surgeons document operative details and complications. The primary outcome is survival measured over 36 months. Follow-up includes monitoring for disease-free survival and safety. Participants must be able to attend follow-up visits and provide consent to share health information.

This research evaluates the combination of two drugs, cabozantinib and nivolumab, in treating patients with advanced melanoma or squamous cell cancers of the head and neck that have spread locally or to distant parts of the body. The study focuses on how well patients can be grouped based on specific tumor biomarkers called tumor mutational burden and tumor inflammation signature. It also aims to understand if this drug combination can shrink or stabilize tumors and how responses vary with biomarker status. This is a phase II trial assessing both the feasibility of biomarker-based patient grouping and the treatment's overall response rate. Participants receive nivolumab intravenously once every 28-day cycle and take cabozantinib orally every day for up to two years unless the disease worsens or side effects become unacceptable. The study includes two stages focusing on molecular characterization and treatment efficacy. Patients undergo tumor biopsies at screening and optionally during follow-up, along with regular imaging scans like CT or MRI and blood sample collections throughout the study. During the trial, patients are closely monitored through scans, blood tests, and biopsies to track tumor response and safety. After treatment ends, follow-up visits occur every 12 weeks for one year and then every six months for up to three years. Key outcomes include the time to get biomarker results within 21 days and the overall tumor response rate at the end of the first stage. The study also assesses disease control, progression-free survival, overall survival, and safety of the drug combination in relation to tumor biomarkers.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

Researchers are evaluating whether using the PAGODA algorithm to guide chemotherapy dosing can reduce unplanned delays during chemotherapy for cancers in the gastrointestinal system compared to usual care. This study focuses on patients receiving FOLFOX chemotherapy, a standard treatment for various gastrointestinal cancers including esophageal, stomach, colon, rectal, and others. The trial aims to compare the proportion of chemotherapy cycles with unplanned delays, as well as secondary measures like healthcare contact days, incidence of moderate-to-severe neutropenia, and relative dose intensity of chemotherapy drugs. Participants are randomized into two groups. One group receives chemotherapy delays and dose changes based on the treating clinician's judgment during cycles 2 to 7 of FOLFOX chemotherapy. The other group receives dose modifications guided by the PAGODA algorithm, with final decisions by the clinician, during the same cycles. The chemotherapy drugs used include oxaliplatin, folinic acid, and fluorouracil, all given intravenously. The study is interventional and compares the algorithm-guided treatment to standard care. Throughout the trial, participants will be monitored for unplanned chemotherapy delays across cycles 2 to 7, with each cycle lasting 14 days. Researchers will also track healthcare contact days, neutrophil counts, and dose intensity of chemotherapy drugs. Safety and effectiveness measures will be assessed during the treatment period to understand how the PAGODA algorithm affects treatment delivery and patient outcomes.

Researchers are evaluating a new medicine called PF-08634404 to understand how it works when combined with other cancer medicines in people with advanced solid tumors, specifically advanced non-small cell lung cancer (NSCLC) that has spread and cannot be removed by surgery or cured with standard treatments. The study aims to assess the safety of PF-08634404 with other cancer drugs, observe possible side effects, and determine if this combination can help treat solid tumors. This trial includes Phase 1 and Phase 2 parts to explore safety, dosing, and early effectiveness. Participants will receive PF-08634404 combined with different cancer medicines through intravenous (IV) infusions at clinical trial sites. Part A tests PF-08634404 with a medicine called sigvotatug vedotin, while Part B examines the new medicine with another combination agent. All treatments are administered by trained medical staff who monitor participants during and after each visit. During the study, participants will be closely monitored for any treatment-related side effects and serious adverse events for up to 90 days after their last treatment, with some follow-up extending up to approximately 5 years. The study will also evaluate participants’ tumor response by standard criteria over this period. Participants undergo regular health assessments, scans, and laboratory tests to track safety, side effects, and effectiveness throughout the trial.

Researchers are evaluating whether adding docetaxel chemotherapy to the usual hormonal therapy and apalutamide treatment improves outcomes for men with prostate cancer that has spread to other parts of the body. This phase III trial focuses on men with metastatic castrate-sensitive prostate cancer and aims to assess overall survival, progression times, symptom control, and quality of life among other outcomes. The study also explores how genetic tumor changes and disease volume impact treatment effectiveness. Participants are randomly assigned to one of two groups. One group receives androgen deprivation therapy (ADT) and daily oral apalutamide, while the other group receives the same plus intravenous docetaxel every 21 days for up to six doses. Treatments are given in 12-week cycles as long as the disease does not worsen or side effects are unacceptable. Throughout the study, participants undergo imaging scans including CT, MRI, bone scan, and optionally PSMA PET scans, along with blood sample collection. After completing treatment, participants are followed every six months for up to ten years. Researchers monitor overall survival, time to disease progression, symptom changes, quality of life scores, and safety using various questionnaires and clinical assessments. The study also collects data on tumor markers and imaging to better understand treatment responses and disease characteristics over time.

Researchers are evaluating how well biomarker tests on tumor tissue can help select personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This phase II trial aims to identify specific cancer subtypes based on biomarker results, which guide the selection of targeted maintenance treatments. The study also compares different maintenance therapies using drugs durvalumab, saruparib, ceralasertib, or monalizumab, which work by helping the immune system fight cancer or by blocking cancer cell growth and repair mechanisms. The study includes an induction phase where patients receive standard chemotherapy with platinum compounds, etoposide, and durvalumab every 28 days for 4 to 6 cycles. Some patients may also undergo thoracic radiation if needed. After induction, patients are assigned to one of three treatment cohorts based on their cancer subtype and SLFN11 biomarker status. Within each cohort, participants are randomized to receive maintenance therapy with durvalumab alone or durvalumab combined with either saruparib, ceralasertib, or monalizumab, depending on the cohort. Maintenance treatments are given in 28-day cycles until disease progression or unacceptable side effects. Participants undergo regular CT scans, PET/CT scans, or MRI to monitor their cancer throughout the study. Tissue samples are collected at screening, and blood samples may be taken during the trial. After completing study treatment, patients are followed for up to 3 years to assess outcomes such as progression-free survival and overall safety. Researchers also monitor side effects and collect specimens for future research. The study measures how well biomarker testing can assign patients to appropriate treatment groups and evaluates the effectiveness and safety of the maintenance therapies.