Heilbronn

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating treatment options for patients with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary who have no remaining tumor after primary tumor debulking surgery. This phase II, multicenter, randomized, open-label study aims to compare the recurrence-free survival between patients receiving 3 cycles versus 6 cycles of carboplatin plus paclitaxel chemotherapy, followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two treatment groups one group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib maintenance therapy starts at a dose of 200 mg or 300 mg once daily and continues until disease progression, unacceptable side effects, or other stopping criteria. Tumor assessments using CT or MRI scans are done at specific intervals, and the tumor marker CA-125 is measured every 12 weeks. Clinical visits for blood tests and toxicity monitoring occur regularly during chemotherapy and niraparib maintenance. During the study, participants will attend clinical visits for safety monitoring, including adverse event tracking, blood counts, physical exams every 12 weeks, and serum pregnancy tests for women of childbearing potential. Tumor evaluations occur 9 to 12 weeks after starting therapy and then every 6 months. The study will follow patients for up to 8 years to measure recurrence-free survival and other outcomes such as overall survival, quality of life, and safety. About 640 patients will be recruited across approximately 60 sites in six European countries over 36 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating targeted therapies and immunotherapy for people with metastatic colorectal cancer mCRC that have specific biomarkers. This open-label, exploratory Phase 11b study aims to assess the safety and effectiveness of these treatments alone or in combination. Eligible participants will be assigned to treatment arms based on their tumor biomarker test results to better understand how these therapies work in different subgroups of mCRC. Participants may receive various drug combinations including oral inavolisib, intravenous IV cetuximab, bevacizumab, atezolizumab, tiragolumab, SY-5609, divarasib, and chemotherapy regimens such as FOLFOX or FOLFIRI. Treatment cycles typically last 21 or 28 days, with dosing schedules varying across arms, including daily oral medications and IV infusions on specific days. Some arms are actively recruiting, while others are closed or not currently enrolling. During the study, participants will undergo regular assessments including tumor measurements to evaluate response, blood tests to monitor drug levels and safety, and collection of tumor tissue for biomarker research. The primary outcome is the objective response rate over about 7 years. Secondary outcomes include duration of response, disease control rate, and adverse event monitoring. Participants are followed long-term to assess treatment effects and safety, with study participation lasting up to approximately 84 months.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as a first-line treatment for patients with advanced biliary tract cancer BTC. This phase III, randomized, open-label study aims to improve treatment options for patients with unresectable locally advanced or metastatic BTC who have not received prior therapy for advanced disease. The study focuses on overall survival and other important outcomes over approximately four years. Participants receive either rilvegostomig or durvalumab through intravenous infusion along with chemotherapy drugs gemcitabine and cisplatin. Durvalumab is given every three weeks for up to eight cycles, then every four weeks. Gemcitabine and cisplatin are administered intravenously on Days 1 and 8 of each 21-day cycle. The study compares these two treatment combinations to assess their effects on survival, disease progression, tumor response, and safety. During the study, participants undergo regular assessments including imaging scans like CT or MRI to measure disease status, laboratory tests to evaluate organ function, and evaluations of symptoms and quality of life. Researchers monitor drug levels and immune response markers. The study lasts about four years, with ongoing safety and health status monitoring throughout. Patient-reported symptoms and quality of life are assessed up to 12 weeks after disease progression.

Researchers are evaluating the efficacy and safety of ifinatamab deruxtecan I-DXd in adults with various recurrent or metastatic solid tumors. These tumor types include endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinoma of the esophagus, gastroesophageal junction and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low and HER2 IHC 0 breast cancer, cutaneous melanoma, and neuroendocrine carcinoma. The study includes multiple phases to assess treatment effects and safety in these diverse groups. Participants receive I-DXd via intravenous infusion, typically dosed at 12 milligrams per kilogram, except in hepatocellular carcinoma where the dose is determined separately. The study is divided into three parts Stage 1, Stage 2, and an optional Stage 3 expansion for endometrial cancer, depending on safety and efficacy results. Each participant starts at Stage 1 and may continue to Stage 2 based on observed data. The hepatocellular carcinoma group includes a safety run-in phase to evaluate tolerability. Participants engage in regular assessments including imaging scans to measure tumor response and disease progression. Researchers monitor treatment-related side effects and collect blood samples to study how the drug behaves in the body over time. The studys main goal is to measure the objective response rate up to about 60 months after the first dose. Safety evaluations continue during treatment and for 47 days after the last dose. Participants may remain in the study for up to five years to track long-term outcomes and overall survival.