Peoria

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

This research is a prospective, longitudinal, non-interventional, multicenter observational study focused on adults with metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma HNSCC. It aims to analyze tissue and blood molecular biomarker profiles during their standard first-line immunotherapy or combination therapy. The study is designed to explore DNA, RNA, immune, and other multiomic biomarkers to identify prognostic or predictive markers that may guide future research. Participants include up to 500 adults with tumors in the pharynx, larynx, oral cavity, or oropharynx who are receiving first-line anti-PD1 or PDL1 immunotherapy or combination treatments as part of routine care. There is no study intervention beyond standard treatment. Tumor tissue samples and longitudinal blood samples will be collected for molecular biomarker analysis over a 5-year period. During the study, participants will provide tumor tissue representative of their current disease and serial blood samples for biomarker evaluation. Researchers will assess changes in DNA, RNA, immune markers, and circulating tumor DNA ctDNA to understand disease progression, treatment response, and resistance mechanisms. The study will monitor participants for up to 5 years to collect data correlating biomarkers with real-world outcomes.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Researchers are evaluating BNT324, a new drug, compared to the current standard chemotherapy treatment docetaxel with prednisone or prednisolone in men with metastatic castration-resistant prostate cancer mCRPC. This study focuses on participants who have previously been treated with androgen receptor pathway inhibitors but have not received taxane-based chemotherapy for mCRPC. The main goals are to see if BNT324 can help participants live longer without their cancer worsening and improve overall survival. Participants are randomly assigned to one of two groups one group receives BNT324 through intravenous infusion, and the other group receives docetaxel infusions combined with oral prednisone or prednisolone. The study includes a screening period lasting up to 28 days, followed by treatment cycles every 21 days. Treatment continues until the cancer clearly worsens, side effects become unacceptable, the participant chooses to stop, or the study ends. After treatment, there is a 30-day safety follow-up and a long-term survival observation that may last up to about 58 months. During the study, participants undergo regular assessments including scans reviewed by an independent committee, laboratory tests, and evaluations of symptoms and side effects. Researchers will monitor how long participants live without cancer progression and overall survival, as well as other measures like response to treatment and time to symptom worsening. Safety is closely tracked throughout treatment and follow-up. The total time a participant may be involved in the study, including follow-up, is up to approximately 58 months.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction HFpEF, a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drugs safety and biological effects.

Researchers are investigating the best way to combine chemotherapy and radiation therapy for patients aged 3 to 29 years with localized non-germinomatous germ cell tumors NGGCT in the brain. This phase II trial aims to optimize treatment based on how well the tumor responds to initial chemotherapy, with the goal of reducing spinal cord relapses and adjusting therapy for better disease control. The study also compares different radiation types and examines cognitive and physical effects in children and young adults with NGGCT. Participants first receive induction chemotherapy consisting of carboplatin, etoposide, and ifosfamide over six cycles every 21 days. Based on tumor response, patients are assigned to one of two plans Plan A involves whole ventricular plus spinal canal irradiation WVSCI, delivered daily for 6 weeks, while Plan B includes high-dose chemotherapy with stem cell transplant followed by radiation therapy to the whole brain and spine. Some patients may undergo second-look surgery depending on tumor response before continuing treatment. Throughout the study, participants undergo MRI scans, collection of cerebrospinal fluid and blood samples, and questionnaires assessing cognitive, social, and behavioral functioning. Researchers monitor tumor response, progression-free survival, overall survival, and patterns of disease recurrence for up to 10 years. Safety and side effects are also evaluated to better understand long-term outcomes of these treatment approaches.

Researchers are evaluating treatments for participants with KRASNRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer who have previously received chemotherapy. The study compares how long participants remain free of disease progression and the overall survival time when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. This Phase 3 trial focuses on patients who have already undergone prior chemotherapy for their cancer. Participants are randomly assigned to one of two groups. One group receives amivantamab combined with the chemotherapy regimen FOLFIRI, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with the same chemotherapy regimen FOLFIRI. Treatments are given in 28-day cycles and continue until the cancer progresses or other criteria require stopping treatment. During the study, participants undergo regular assessments to monitor disease status, including imaging scans reviewed by independent experts. Researchers measure progression-free survival and overall survival over periods up to several years. Additional outcomes include response rates, duration of response, quality of life assessments, and side effects. Safety and laboratory evaluations are conducted throughout the study, which spans up to four years and four months in total duration.