Green Bay

Researchers are evaluating the effectiveness of pemigatinib in adults with advanced or metastatic pancreatic cancer that has spread to nearby tissues, lymph nodes, or distant body parts, and that have specific genetic changes in the FGFR gene. The study focuses on patients whose cancer has FGFR2 gene fusions or other FGFR alterations, aiming to see if pemigatinib can block these abnormal gene functions to stop tumor growth and possibly improve quality of life. This is a phase II trial conducted nationwide using a fully decentralized telemedicine approach to reach participants. Participants receive pemigatinib as an oral medication once daily for 14 days within each 21-day cycle. Treatment continues unless the disease progresses or unacceptable side effects occur. Alongside the drug treatment, patients undergo various imaging tests including CT scans, MRI, optical coherence tomography (OCT), and when needed, whole body bone scans and dilated eye exams (ophthalmoscopy). After finishing treatment, patients are followed up at 30 days and then every four months for one year to monitor their condition. Throughout the study, patients provide blood samples and undergo scans to evaluate treatment response and detect resistance mutations. Researchers track the overall response rate for up to 24 months and assess safety and tolerability. Patients must comply with scheduled visits, tests, and oral medication intake. The total study participation includes treatment cycles and a follow-up period lasting up to approximately 16 months after treatment completion.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating combination chemotherapy treatments for patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) and relapsed favorable histology Wilms tumors (FHWT). This phase II trial aims to assess how adding vincristine and irinotecan to standard chemotherapy regimens affects event-free survival and overall survival compared to historical data. The study also explores kidney toxicity, tumor genetics, and radiation therapy techniques to reduce side effects in children with lung and liver metastases. Two chemotherapy regimens are studied. Arm I (Regimen UH-3) involves cycles of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan given intravenously on specific days every 21 days. Radiation therapy is given around week 7 of cycle 3 if needed. Arm II (Regimen ICE/Cyclo/Topo) includes cycles of ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan given intravenously every 21 days, with surgery and/or radiation during certain cycles. Both arms include multiple cycles in absence of disease progression or unacceptable side effects. Participants undergo various scans like CT, PET, MRI, chest x-rays, ultrasounds, and bone scans throughout the trial. Blood samples and biopsies may be collected periodically. After treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-4, and once at year 5. The main outcomes measured are event-free survival and overall survival up to 5 years, along with monitoring kidney health and treatment effects.

Researchers are evaluating the combination of blinatumomab with dasatinib or imatinib alongside standard chemotherapy to treat patients with Philadelphia chromosome-positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia (B-ALL). This phase 2 trial focuses on children, adolescents, and young adults under 25 years with newly diagnosed Ph+ or ABL-class Ph-like B-ALL, aiming to estimate three-year event-free survival (EFS) and assess safety and toxicity of this chemo-immunotherapy approach. Treatment involves a modified Berlin-Frankfurt-Mfcnster chemotherapy backbone with three cycles of blinatumomab replacing traditional consolidation chemotherapy. Patients with Ph+ B-ALL receive continuous dasatinib, while those with ABL-class Ph-like B-ALL receive continuous imatinib or dasatinib depending on specific gene fusions. The study includes multiple treatment phases: induction, blinatumomab blocks, interim maintenance, delayed intensification, and maintenance cycles repeated every 12 weeks for two years, with some patients possibly receiving radiation therapy. Participants undergo blood and cerebrospinal fluid sample collections, bone marrow biopsies, echocardiography or multigated acquisition scans, and various laboratory tests throughout the study. Researchers measure outcomes such as three-year event-free survival, incidence of adverse events, minimal residual disease negativity, treatment response, and overall survival. Safety monitoring includes assessments of infections, neurotoxicity, and therapy-related mortality. The total participation extends up to three years with ongoing evaluations to track treatment effects and side effects.

Researchers are evaluating treatments for children and young adults with newly diagnosed acute myeloid leukemia (AML), with or without FLT3 gene mutations. This phase III trial compares standard chemotherapy using daunorubicin, cytarabine, and gemtuzumab ozogamicin to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or the FLT3 inhibitor gilteritinib. The study aims to find out which treatment improves event-free survival, overall survival, and minimal residual disease rates, while also monitoring heart function and other effects during and after therapy. Participants are assigned to different treatment arms based on their AML risk group and FLT3 mutation status. Treatments include combinations of intravenous and intrathecal chemotherapy drugs such as cytarabine, daunorubicin, gemtuzumab ozogamicin, dexrazoxane, etoposide, mitoxantrone, asparaginase, and methotrexate. Gilteritinib is given orally to patients with FLT3 mutations alongside chemotherapy. Treatment phases include multiple induction cycles, intensification cycles, and for some, allogeneic stem cell transplantation followed by maintenance therapy with gilteritinib. Throughout the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans like MRI and CT, cardiac function monitoring, and neuropsychological testing. Researchers track event-free survival up to 3 years, changes in heart function, leukemia response, and neurocognitive effects. Optional cognitive tests are offered at several time points. The study also collects blood samples for pharmacokinetic and biomarker analyses to better understand treatment effects and safety.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the safety, side effects, and best dose of the drug cabozantinib combined with standard chemotherapy in treating patients newly diagnosed with osteosarcoma. This study aims to compare the effect of adding cabozantinib to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. Cabozantinib is a kinase inhibitor that may slow tumor growth by blocking signals involved in blood vessel formation and growth pathways. The trial includes both phase II and phase III components and involves patients with localized or metastatic high-grade osteosarcoma, including those with pelvic tumors or unresectable disease. During the feasibility phase, patients received cabozantinib orally and standard chemotherapy intravenously in a series of induction, consolidation, and maintenance cycles over several months. In the efficacy phase, patients are randomized into groups receiving either standard chemotherapy alone or combined with cabozantinib, with treatment cycles lasting 35 days each followed by local control procedures like surgery. The study monitors the impact of adding cabozantinib on event-free survival and overall survival. All participants undergo imaging (X-ray, CT, MRI, PET or bone scan) and blood sample collection at diagnosis and throughout the trial. Participants are closely monitored through scans and blood tests at various time points to assess treatment effects and safety. Researchers measure dose-limiting toxicities during the initial 6 weeks and track event-free survival and overall survival for up to five years after completing treatment. The study also collects tumor tissue and blood samples to study tumor DNA and assess response to therapy. Patient-reported outcomes on therapy-specific side effects and symptom burden are evaluated to understand tolerability. The total participation duration varies based on treatment cycles and long-term follow-up assessments.