Bedford

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This study includes both Phase 2 and Phase 3 parts, aiming to determine the best dose of R-DXd and compare it with standard chemotherapy treatments. R-DXd is designed to target CDH6, a protein found in high amounts on tumor cells, to deliver its treatment directly to the cancer. Participants will be randomly assigned to receive intravenous R-DXd at different doses every three weeks or to receive chemotherapy chosen by the doctor, including paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan. The Phase 2 part focuses on finding the recommended dose based on safety and response, while Phase 3 compares R-DXd at the recommended dose against chemotherapy to further assess its effects. Throughout the study, participants will undergo scans to measure tumor response and various assessments to monitor symptoms, side effects, and other health factors. Researchers will track outcomes like tumor shrinkage, survival without disease progression, overall survival, treatment side effects, and quality of life measures for up to 40 months. Participants will have regular visits for treatment, lab tests, and symptom evaluations to ensure close monitoring during the trial.

Researchers are evaluating TRK-950 in combination with ramucirumab and paclitaxel (RAM+PTX) to treat participants with gastric or gastro-esophageal junction adenocarcinoma. This randomized, open-label Phase 2 study aims to assess the efficacy, safety, optimal dose, and antibody development of TRK-950 at two dose levels compared to RAM+PTX alone. The main goal is to measure progression-free survival, along with overall survival, response rates, disease control, safety, pharmacokinetics, and immunogenicity. Participants are randomly assigned to one of three groups: one receiving 5 mg/kg TRK-950 with RAM and PTX, another receiving 10 mg/kg TRK-950 with RAM and PTX, and a third group receiving only RAM and PTX. TRK-950 is given intravenously on days 1, 8, 15, and 22 of each 28-day cycle. Ramucirumab is administered intravenously on days 1 and 15, and paclitaxel is given intravenously on days 1, 8, and 15 of each cycle. During the study, participants undergo regular evaluations including scans to measure tumor response, lab tests to check organ function, and monitoring for side effects. Researchers measure progression-free survival, overall survival, response rates, duration of response, disease control rate, antibody development, and quality of life through questionnaires. Safety is closely observed up to 45 days after the last treatment. The study may continue for approximately 24 months, with assessments scheduled throughout this period.

Researchers are evaluating the safety and effectiveness of an experimental drug called fianlimab, combined with cemiplimab, in treating adults with advanced or metastatic melanoma, a type of skin cancer. This study compares the combination of fianlimab and cemiplimab with an approved treatment combining relatlimab and nivolumab. The study also investigates side effects, drug levels in the blood, and whether the body produces antibodies against the study drugs. Participants receive either fianlimab and cemiplimab every three weeks through intravenous infusion or the combination of relatlimab and nivolumab every four weeks intravenously. The study is randomized with two groups receiving one of these treatments. This is a phase 3 trial designed to gather detailed information about how these drug combinations work in melanoma treatment. During the study, participants will be regularly monitored for tumor response using standard criteria, side effects, survival, and immune responses for up to 72 months. Tests include blood samples to measure drug concentration and antibody formation. Safety evaluations and disease progression assessments will be done throughout the study period to understand the treatments' effects over time.

Researchers are evaluating survival outcomes for patients with early stage cervical cancer undergoing either robotic-assisted laparoscopy or open hysterectomy with lymph node assessment. This multi-center, randomized trial tests the hypothesis that robotic hysterectomy with tumor containment before colpotomy is not inferior to abdominal hysterectomy regarding disease-free survival. The study focuses on patients with specific cervical cancer stages and tumor sizes, aiming to compare surgical approaches. Participants are randomly assigned to one of two groups: the standard open surgery group performing radical or simple hysterectomy using established techniques with vaginal closure over the tumor before colpotomy, and the robotic surgery group using minimally invasive robotic-assisted hysterectomy with vaginal closure prior to intracorporeal colpotomy. Surgeons perform thorough intraoperative assessments for metastatic disease, and certain patients with confirmed metastases are excluded from final analysis. Detailed surgical data and complications are recorded for all cases. During the study, participants will undergo preoperative assessments, surgery, and follow-up evaluations. Researchers will monitor survival over 36 months as the primary outcome, documenting operative time, findings, blood loss, and complications. Patients will be followed to assess disease-free survival, with attention to surgical outcomes and safety. The total duration of participation includes the surgery and long-term survival monitoring to compare the effectiveness of the two surgical methods.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups: one receiving standard endocrine therapy chosen by the doctor (including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen) with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patient's randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of Fertilo compared to Medicult IVM for in vitro maturation (IVM) of eggs in women aged 18 to 35. The study aims to determine if Fertilo leads to more ongoing pregnancies at 12 weeks gestation than the currently approved Medicult IVM system. This is a phase III randomized control trial sponsored by Gameto, Inc.

This research aims to evaluate patient outcomes following shoulder replacement surgery using FX Shoulder Solutions medical devices. The study observes patients who have received these legally marketed devices in the USA to assess their safety, effectiveness, and long-term survivorship. The registry collects data to support regulatory requirements and share findings through presentations and publications. Participants are those implanted with FX Shoulder Solutions' shoulder replacement devices, including various systems like Humelock II and Easytech Anatomical Shoulder System. The registry tracks these patients from surgery onward, with key follow-ups at 2 years to assess clinical success and up to 10 years to monitor device survivorship. Success is defined by measures such as improved shoulder function, no device migration, no revision surgery, and absence of serious device-related adverse events. During the study, patients undergo evaluations at multiple time points including 6 weeks, 3, 6, 12, and 24 months post-surgery using standardized scores like Adjusted Constant Score, QuickDASH, and Visual Analog Scale. Radiographic reviews, range of motion assessments, and tracking of adverse events and secondary surgeries occur up to 5 years. The study involves ongoing monitoring to understand the long-term performance and safety of the shoulder replacement devices.

Researchers are evaluating the effects of human menopausal gonadotropin (hMG) in women diagnosed with infertility undergoing Assisted Reproductive Technology (ART) cycles. This phase 3, multicenter, randomized, placebo-controlled, double-blind study aims to assess the efficacy and safety of hMG in developing multiple follicles, achieving pregnancy, and increasing cumulative live birth rates over a 12-month period. Participants will receive either daily subcutaneous injections of hMG or a placebo. The study involves up to two ovarian stimulation cycles followed by frozen embryo transfer (FET). Researchers will monitor hormone levels, number and quality of oocytes, fertilization rates, blastocyst formation, and pregnancy milestones through various laboratory and imaging assessments. During the trial, participants will undergo regular evaluations including ultrasounds, blood tests for hormone measurements, and embryo biopsies. Researchers will track pregnancy progress through serum hCG tests and ultrasound confirmations of fetal heartbeat. The study follows participants for outcomes such as live birth rates up to nine months after embryo transfer. Participants must comply with study procedures and provide delivery and neonatal health data for the study duration.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points: at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.