Kettering

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

Researchers are collecting data to better understand how CardioFlux Magnetocardiography (MCG) can be used to detect coronary ischemia in patients suspected of this condition. This multicenter observational registry uses standard of care (SOC) cardiac positron emission tomography (PET) as a diagnostic reference to evaluate CardioFlux MCG's potential role in identifying heart blood flow problems over a 24-month period. Participants will undergo CardioFlux MCG, a device that measures the heart's magnetic signals and is paired with cloud-based software for analysis. CardioFlux devices are FDA-cleared for capturing and analyzing magnetic fields from cardiac electrical activity. Patients will have had a cardiac PET scan within two weeks prior to enrollment, which serves as the standard diagnostic comparison. During the study, researchers will gather diagnostic information from cardiac PET and CardioFlux MCG to assess their relationship. Participants will provide informed consent, and their ability to lie still for five minutes will be required for the MCG scan. The study will monitor diagnostic outcomes over 24 months to improve understanding of the use of CardioFlux MCG in coronary ischemia detection.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating a new treatment approach for patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC) in this Phase 3, randomized, double-blind, placebo-controlled study. The study compares the combination of the drug pazopanib with abexinostat against pazopanib with a placebo. The goal is to assess the effectiveness of adding abexinostat to pazopanib in treating this type of kidney cancer. Participants will be randomly assigned in a 2:1 ratio to receive either pazopanib plus abexinostat or pazopanib plus a placebo. Pazopanib is taken orally once daily at 800 mg each morning with water, timed around meals. Abexinostat or its placebo is taken twice daily at 80 mg on specific days within a 28-day treatment cycle, with doses spaced four hours apart and taken around meal times. Treatment will continue until disease progression, unacceptable side effects, withdrawal of consent, or study closure. Patients on placebo who experience disease progression may switch to the combination treatment. Before starting treatment, patients undergo screening within 28 days and receive their first dose within 7 days after randomization. Throughout the study, researchers monitor patients for progression-free survival, which is the time from randomization until disease progression or death, for up to about four years. Regular assessments include imaging scans evaluated by specific criteria, clinical evaluations, and safety monitoring. There is no set maximum treatment duration, allowing patients to continue therapy as long as it remains beneficial and safe.

Researchers are evaluating new treatment options for people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or has come back after prior treatment. This type of cancer starts in the lining of the uterus and is considered advanced when it has spread locally or to other body parts and cannot be removed by surgery. The study aims to compare the effectiveness of sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate, combined with pembrolizumab versus pembrolizumab alone, to see which approach helps people live longer without the cancer worsening. Participants first receive an induction phase of six cycles, each lasting three weeks, of pembrolizumab combined with carboplatin and either paclitaxel or docetaxel through intravenous infusions. Those whose cancer does not progress after this phase enter the maintenance treatment phase, where they are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer does progress, participants may enter a subsequent treatment phase and be randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During the study, researchers monitor participants for progression-free survival and overall survival for up to approximately 44 and 54 months, respectively. Participants undergo regular imaging, assessments, and laboratory tests to evaluate cancer status and treatment effects. The study also tracks safety and tolerability throughout all phases, providing a comprehensive follow-up to understand treatment impact over time.

Researchers are evaluating two treatment combinations for patients with melanoma that has spread to the brain and has a specific BRAF-V600 mutation. This phase II trial compares encorafenib, binimetinib, and nivolumab against ipilimumab and nivolumab to determine which approach better controls and shrinks brain metastases from melanoma. The study also aims to assess overall survival, response rates, treatment duration, and side effects of each regimen. Participants are randomly assigned to one of two groups. One group receives encorafenib orally once daily, binimetinib orally twice daily, and nivolumab intravenously every 28 days. The other group receives nivolumab intravenously and ipilimumab intravenously during the first four cycles, with cycles every 21 days initially, then every 28 days thereafter. Treatment continues unless the disease worsens or side effects become unacceptable. After treatment ends, participants have follow-up visits every six months for two years, then yearly until three years after starting the study. During the trial, participants undergo brain MRIs to monitor tumor response using standardized criteria. Imaging, tumor tissue, spinal fluid, stool, and blood samples are collected for research. Safety and effectiveness are carefully assessed through scans, physical exams, lab tests, and side effect monitoring. Progression-free survival up to three years after randomization is the main outcome. Participants remain in the study for about three years with periodic evaluations to track their health and disease status.

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.

Researchers are evaluating the safety and effectiveness of the AlphaReturn Blood Management System used together with the cleared AlphaVac Multipurpose Mechanical Aspiration (MMA) System for treating acute pulmonary embolism. This prospective, multicenter, single-arm study focuses on patients with intermediate-risk pulmonary embolism diagnosed by computed tomography angiography (CTA) and presenting symptoms for 14 days or less. The study aims to monitor device safety and success in removing clots. Participants will receive treatment using the AlphaVac MMA System for thrombectomy, with the AlphaReturn Blood Management System allowing reinjection of aspirated blood during the procedure. The study involves a single treatment procedure, and safety and effectiveness will be evaluated through device-related adverse event rates up to 30 days post-procedure and technical success during the procedure. During the study, participants will be assessed through clinical monitoring, imaging, and laboratory tests such as blood counts and creatinine levels. Researchers will track heart rate, blood pressure, oxygen needs, and right to left ventricle ratio. Follow-up includes evaluation of adverse events and overall health status up to 30 days after treatment to ensure safety and measure outcomes related to the device and procedure.

Researchers are evaluating the safety and effectiveness of lutetium (177Lu) vipivotide tetraxetan (AAA617) in adult men with oligometastatic prostate cancer (OMPC) that is progressing after initial treatment to the primary tumor. This Phase III study aims to determine if AAA617 can control recurrent tumors and delay the need for androgen deprivation therapy (ADT), while preserving quality of life. The study focuses on early-stage prostate cancer patients with limited metastatic lesions that are positive for prostate-specific membrane antigen (PSMA). All participants will undergo a baseline PET/CT scan using either gallium (68Ga) gozetotide or piflufolastat (18F) to confirm PSMA-positive lesions, along with conventional imaging such as CT/MRI and bone scans. Following randomization, all metastatic lesions will receive stereotactic body radiation therapy (SBRT) over approximately 3 weeks. Participants randomized to the investigational arm will then receive up to 4 cycles of AAA617 treatment, given once every 6 weeks. Those in the observation group will end treatment after SBRT. Visits are scheduled weekly during treatment cycles and every 16 weeks afterward until disease progression, with the overall study lasting about 6.5 years. During the study, participants will have regular assessments including imaging scans, laboratory tests, and clinical evaluations to monitor disease progression and side effects. A blinded independent review committee will measure metastasis-free survival, tracking time from randomization until evidence of distant metastasis or death, for up to 30 months. Safety and quality of life will also be closely monitored throughout the study and follow-up periods.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.