Edina

Researchers are investigating new treatment options for metastatic cervical cancer, a type of cancer that starts in the cervix and has spread to other parts of the body. This study focuses on evaluating sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate designed to target cancer cells, in combination with pembrolizumab and bevacizumab. The main goals are to assess the safety and tolerability of these drugs given together and to see if they help patients live longer or delay cancer progression compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab to assess safety. In Part 2, all participants first receive standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, with optional bevacizumab. Those whose cancer does not worsen then start maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may also be added during maintenance at the doctor's discretion. Treatments are given through intravenous infusions on schedules that range from every 2 to 6 weeks, lasting up to approximately 20 months. During the study, participants will have regular evaluations to monitor safety and how well the treatments work. Assessments include tracking side effects, cancer progression using imaging criteria, overall survival, and quality of life questionnaires focused on health status and physical function. The research team will observe participants for several years to collect data on treatment outcomes and tolerability, with some follow-up lasting up to about 69 months.

Researchers are investigating new treatments for neovascular age-related macular degeneration (NVAMD), a form of wet macular degeneration. This study aims to find out if a medicine called tiespectus (also known as MK-8748 or EYE201) can treat NVAMD as effectively as the current standard treatment, aflibercept. The trial is a pivotal Phase 2/3 study comparing these treatments in people with this eye condition. Participants will be randomly assigned to one of three groups: one receiving a low dose of tiespectus, another receiving a high dose of tiespectus, and a third group receiving aflibercept. The tiespectus groups start with three injections every four weeks, then continue with injections every eight weeks until week 48. After this, the treatment schedule is personalized up to week 92. The aflibercept group also receives three initial injections followed by injections every eight weeks until week 92. During the study, participants will have their vision assessed using best-corrected visual acuity (BCVA) and other eye measurements at baseline and through one year. Researchers will monitor changes in vision, eye thickness, and any side effects. The entire study period includes treatment and follow-up visits up to approximately 92 weeks, allowing detailed observation of treatment effects and safety over time.

Researchers are comparing the effectiveness of a combination treatment including tarlatamab, durvalumab, carboplatin, and etoposide to a similar combination without tarlatamab in people with untreated extensive stage small-cell lung cancer (ES-SCLC). This Phase 3 study aims to see if adding tarlatamab can improve overall survival and progression-free survival in this patient group. The study is sponsored by Amgen and focuses on first-line treatment options for this aggressive cancer stage. Participants are assigned randomly to one of two groups. One group will receive tarlatamab combined with durvalumab, carboplatin, and etoposide for four cycles, followed by maintenance treatment with tarlatamab and durvalumab. The other group receives durvalumab, carboplatin, and etoposide for four cycles, followed by durvalumab alone. All drugs are given through intravenous infusions. The study is open-label, meaning both participants and researchers know which treatment is being given. During the study, participants will be monitored up to approximately 3.5 years for overall survival and progression-free survival through blinded independent central review. Additional outcomes like objective response, disease control, duration of response, and treatment-related side effects will be tracked for up to four years. Blood samples will be taken to measure tarlatamab levels and to check for antibodies against the drug. Safety and treatment effects are carefully recorded throughout the study period.

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 a new medication called CX11 for adults with type 2 diabetes who have not achieved adequate blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This phase 2 study is randomized, double-blind, and placebo-controlled, aiming to determine the safety and effectiveness of different doses of CX11 in comparison to placebo. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 (40 mg, 80 mg, 120 mg, 160 mg, or 200 mg) or a matching placebo. The medication is taken orally once daily for 24 weeks, followed by a 2-week safety follow-up period. The study is conducted across multiple medical centers and neither participants nor staff will know the group assignments during the trial. Throughout the study, participants will undergo regular assessments including blood tests to measure changes in HbA1c (a marker of blood sugar control), fasting plasma glucose, body weight, and blood pressure. Continuous glucose monitoring will track time spent in the target glucose range. Safety is monitored by recording adverse events and measuring plasma drug levels at specified intervals. The total participation period is approximately 26 weeks.

Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by immune system proteins building up in the kidneys, leading to inflammation and potential kidney damage. This trial aims to evaluate how mezagitamab affects protein levels in the urine compared to a placebo in adults with primary IgAN. The study also looks at the safety and tolerability of mezagitamab, along with its ability to maintain kidney function over time. Participants will be assigned randomly to one of two groups in the main part of the study: one receiving mezagitamab injections and the other receiving placebo injections, both given under the skin. Treatment lasts about 22 weeks within each 52-week cycle, with two such cycles planned. There is also an open-label group for certain participants who have lower protein levels or reduced kidney filtering ability; they will receive mezagitamab treatment similar to the main group. Participants will have monthly check-ups and be closely monitored throughout. During the study, participants will visit the clinic multiple times for assessments including urine protein measurements, kidney function tests, and safety monitoring. The main outcome is the change in urine protein at week 36, with additional measures of kidney filtering rate and kidney failure risk tracked up to week 104. The study duration and follow-up ensure thorough observation of treatment effects and safety over two years.

Researchers are evaluating DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis (FSGS) who are also receiving an angiotensin II receptor blocker (ARB). This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine protein/creatinine ratio and kidney function tests like estimated glomerular filtration rate (eGFR) at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.

Researchers are evaluating whether adding tucatinib to trastuzumab and mFOLFOX6 works better than the current standard treatments for people with HER2 positive metastatic colorectal cancer. This study focuses on participants whose cancer has spread or cannot be removed by surgery. The trial also monitors side effects that might occur from taking these drug combinations. Participants are randomly assigned to one of two groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every three weeks and mFOLFOX6 chemotherapy every two weeks. The other group receives standard care, which includes mFOLFOX6 alone or combined with bevacizumab or cetuximab given by intravenous infusion. The study treatments continue as per the assigned schedule. During the study, participants undergo regular scans and evaluations to measure progression-free survival and other outcomes up to approximately three years. Researchers also assess overall survival, response rates, duration of response, quality of life, and side effects for up to about six years. Safety monitoring continues for around one year after the last treatment. Participants are closely followed to understand the impact of these treatments on their cancer and well-being.

Researchers are evaluating the effect of zigakibart on the progression of Immunoglobulin A Nephropathy (IgAN), a kidney disease. This open-label, multicenter Phase 2 study involves adult patients with confirmed primary IgAN. Participants are randomized into two groups that differ only by the timing of a kidney biopsy, either at the end of the first or second year of treatment. Participants will receive zigakibart injections of 600 mg under the skin every two weeks for up to two years. The study includes a screening period of up to 8 weeks, followed by 104 weeks of treatment, and a safety follow-up period of 13 weeks. The treatment effects will be monitored through kidney biopsies and various markers of kidney disease. During the study, participants will undergo assessments including kidney biopsies, blood and urine tests to evaluate kidney function and disease markers, and safety monitoring for adverse events. Researchers will measure changes in IgA deposition in the kidneys, proteinuria, kidney filtration rate, and other blood markers over time. The total duration of participation may be up to 125 weeks, including screening, treatment, and follow-up.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage (stage I and II) classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments: some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.