Tappahannock

Researchers are conducting a randomized controlled trial to compare survival outcomes between robotic-assisted laparoscopy and open hysterectomy with lymph node assessment for early-stage cervical cancer. The study aims to determine if robotic hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy in terms of disease-free survival. It includes patients with specific cervical cancer stages and tumor sizes suitable for surgery. Participants will undergo either a radical or simple hysterectomy using either traditional open surgery or a robotic-assisted technique. In the robotic group, the vagina is closed before colpotomy, and certain vaginal manipulators are not allowed. Both groups may have salpingectomy and oophorectomy with or without ovarian transposition. Surgeons will document operative details, including any complications, blood loss, and reasons for conversion to open surgery. During the trial, participants will be closely monitored with preoperative assessments like labs, EKG, and MRI to confirm eligibility. Surgical findings and complications will be recorded. The primary outcome measured is survival at 36 months. Participants must provide informed consent and undergo follow-up to assess disease status and survival over the study period, which extends until 2030.

This research aims to evaluate the combination of two drugs, cabozantinib and nivolumab, in treating advanced melanoma or squamous cell head and neck cancer that may have spread locally or to distant parts of the body. The study focuses on how these drugs affect tumor growth and the immune systems ability to fight cancer. It also investigates how quickly patients can be grouped based on tumor biomarkers, specifically tumor mutational burden and tumor inflammation signature, to understand differences in treatment responses. Participants receive nivolumab through intravenous infusion on the first day of each 28-day cycle and take cabozantinib orally every day. Treatment cycles continue for up to two years unless the disease progresses or side effects become unacceptable. During the study, patients undergo CT or MRI scans and blood sample collections. Tumor biopsies are taken during screening and may be repeated during follow-up. After treatment ends, participants are monitored every 12 weeks for one year and then every six months for up to three years. Throughout the trial, participants are assessed with imaging scans and blood tests to monitor cancer status and treatment effects. Researchers measure the time to receive biomarker results and evaluate tumor response rates. They also track safety, disease control, progression-free survival, and overall survival over the two years of treatment. Specimens are banked for future research. Participants remain under observation for several years after treatment to gather long-term data on outcomes and safety.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

Researchers are studying vulnerable or older adults aged 70 and above with recurrent or metastatic non-small cell lung cancer NSCLC that has a PD-L1 tumor proportion score TPS less than 50%. The study aims to evaluate how often treatment-related side effects cause patients to stop chemotherapy when receiving a reduced dose of chemotherapy combined with immunotherapy. This is a phase 2, single-arm, open-label study assessing safety and tolerability in this specific patient group. Participants with squamous cell NSCLC will receive carboplatin and paclitaxel chemotherapy every 21 days for 4 cycles, while those with non-squamous NSCLC will receive carboplatin and pemetrexed on the same schedule. Both groups will receive pembrolizumab immunotherapy every 21 days for up to 35 cycles or until disease progression or unacceptable side effects occur. The first 4 cycles include chemotherapy plus immunotherapy, followed by maintenance immunotherapy alone from cycle 5 onward. During the study, participants will be closely monitored for treatment side effects, response to therapy, survival outcomes, and quality of life at multiple time points up to several years. Researchers will collect data on adverse events, disease progression, and cancer symptoms through scans, lab tests, and questionnaires. The primary outcome is the rate of chemotherapy discontinuation due to side effects over up to two years of treatment. Secondary outcomes include response rates, overall survival, progression-free survival, and symptom changes up to five years.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

Researchers are evaluating whether using the PAGODA algorithm to guide chemotherapy dosing can reduce unplanned delays during chemotherapy for cancers in the gastrointestinal system. This study compares the PAGODA algorithm against usual care in patients receiving FOLFOX chemotherapy. The trial aims to assess the effect on treatment scheduling, healthcare contact days, severity of neutropenia, and chemotherapy dose intensity. Participants are randomly assigned to one of two groups. One group receives chemotherapy dose adjustments and delays based on the PAGODA algorithm followed by clinician decision during cycles 2 to 7 of standard FOLFOX chemotherapy. The other group receives dose modifications and delays at the treating clinicians discretion during the same chemotherapy cycles. Treatments include intravenous oxaliplatin, folinic acid, and fluorouracil. During the study, participants will be monitored for unplanned chemotherapy delays from cycle 2 through cycle 7, with each cycle lasting 14 days. Researchers will also track health care contact days over 120 days, moderate-to-severe neutropenia, and relative dose intensity of key chemotherapy drugs. The study involves randomized assignment and careful evaluation of treatment timing and dosing effects in patients receiving chemotherapy for gastrointestinal cancers.

Researchers are studying 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 cured with surgery or standard treatments. This study is an interventional Phase 1B2 trial sponsored by Pfizer, focusing on treatment safety, side effects, and effectiveness. The trial evaluates PF-08634404 combined with different anticancer agents to explore their impact on these advanced cancers. Participants will receive PF-08634404 through intravenous IV infusion along with other cancer medicines. The study is divided into parts Part A tests PF-08634404 with Sigvotatug Vedotin, and Part B evaluates PF-08634404 with another anticancer agent. All treatments and infusions are given at clinical trial sites under medical supervision, with careful monitoring during and after each visit. During the study, participants will undergo assessments to track safety by monitoring adverse events and serious adverse events up to 90 days after the last dose and for up to approximately 5 years. Researchers will measure responses using imaging criteria RECIST v1.1 to evaluate tumor response and disease control. Additional tests include laboratory evaluations, pharmacokinetics to measure drug levels, and monitoring for immune reactions. The study duration spans several years with ongoing safety and efficacy evaluations.

Researchers are evaluating the effect of adding docetaxel chemotherapy to the usual hormonal therapy and apalutamide treatment for men with prostate cancer that has spread to other parts of the body. This phase III trial focuses on metastatic castrate-sensitive prostate cancer and aims to see if the combination improves overall survival and other important outcomes compared to hormonal therapy and apalutamide alone. The study also explores genetic factors, disease progression, symptoms, quality of life, and imaging correlations to better understand treatment impact. Participants are randomly assigned to one of two groups. One group receives androgen deprivation therapy ADT and apalutamide taken orally daily on a 12-week cycle unless disease progresses or side effects occur. The other group receives the same ADT and apalutamide treatment plus docetaxel given intravenously every 21 days for up to six doses. Throughout the study, participants undergo CT or MRI scans and bone scans, with optional PSMA PET scans and blood sample collections to monitor disease status. During the trial, participants complete questionnaires about symptoms and quality of life. Researchers assess overall survival, radiographic progression, time to castration-resistant prostate cancer, skeletal event-free survival, and treatment safety for up to 10 years after randomization. Additional measures include PSA response, disease progression, and genetic markers. Follow-up visits occur every six months after treatment completion, supporting long-term monitoring and safety evaluation.

The trial investigates total neoadjuvant therapy combining chemotherapy and short-course radiation in patients with resectable rectal cancer. It is a phase 2 study focusing on improving treatment outcomes before surgery or active surveillance for those with complete clinical response. The goal is to evaluate disease-free survival over three years after treatment or surgery. Participants receive four cycles of systemic chemotherapy with mFOLFOX6 before starting chemoradiotherapy, which includes pelvic intensity-modulated radiation therapy IMRT and continuous infusion of 5-fluorouracil 5-FU for four days. Following chemoradiotherapy, participants undergo consolidation with an additional four cycles of mFOLFOX6 before surgery or may opt for non-operative active surveillance if they achieve a complete clinical response. During the study, participants are monitored through clinical assessments, imaging, and biopsy to evaluate tumor response and safety. Researchers measure outcomes such as three-year disease-free survival, pathologic and clinical complete response rates, adverse events, progression-free survival, overall survival, and the need for ostomy at surgery. The trial involves careful observation for up to five years post-treatment to assess long-term effects.

Researchers are evaluating biomarker tests on tumor tissue to select personalized maintenance treatments for patients with extensive stage small cell lung cancer ES-SCLC. This phase II trial aims to determine how well these tests identify cancer subtypes and guide targeted therapies. The study also compares different maintenance treatments, including durvalumab, saruparib, ceralasertib, and monalizumab, which may affect tumor growth and immune response. Participants receive induction treatment with a platinum compound, etoposide, and durvalumab every 28 days for 4 to 6 cycles. After possible thoracic radiation, they are assigned to one of three cohorts based on cancer subtype and SLFN11 status. Each cohort is randomized to receive durvalumab alone or combined with another drug saruparib for cohort A, ceralasertib for cohort B, or monalizumab for cohort C. Maintenance cycles repeat every 28 days if disease does not progress or toxicity occurs. During the study, participants undergo imaging tests such as CT, PETCT, or MRI scans, and tissue and blood samples are collected for analysis. Researchers monitor progression-free survival and overall survival, as well as treatment safety and side effects, for up to three years. After completing study treatment, patients are followed for up to three years to assess long-term outcomes and collect specimens for future research.