Paderborn

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

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 the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are evaluating treatments for patients with high-risk chronic lymphocytic leukemia CLL, a type of blood cancer that is aggressive and currently incurable. This phase 3, open-label, multicenter, randomized study aims to compare the effectiveness of a triple drug combination acalabrutinib, obinutuzumab, and venetoclax against a double combination obinutuzumab and venetoclax in prolonging progression-free survival PFS for patients with specific high-risk genetic features such as 17p-deletion, TP53 mutation, complex karyotype, or unmutated IGHV gene status. The study addresses a crucial medical need for better treatments in this difficult-to-treat group. Participants will be randomly assigned to one of two treatment groups. One group receives the triple combination of acalabrutinib, obinutuzumab, and venetoclax, while the other group receives obinutuzumab plus venetoclax. Obinutuzumab is given as intravenous infusions on specific days across six cycles. Venetoclax is taken orally with a carefully planned dose escalation and maintenance over 12 cycles. Acalabrutinib is administered orally twice daily during cycles 15 to 24. The study explores whether adding acalabrutinib improves outcomes by using these fixed-duration, chemotherapy-free regimens. Throughout the study, participants will undergo regular assessments to monitor response and safety, including checks for minimal residual disease MRD and overall survival. These evaluations occur up to 50 months after the first patient is enrolled. Researchers will also track progression-free survival, complete and overall response rates, event-free survival, duration of response, and time to next treatment. Safety monitoring and laboratory tests will be performed as part of study visits. The total study participation is expected to last several years to capture long-term outcomes for this high-risk patient population.

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of inavolisib combination therapies in women with untreated, PIK3CA-mutated, Stage II-III estrogen receptor-positive, HER2-negative breast cancer. This Phase II, open-label study focuses on early-stage breast cancer patients who are candidates for neoadjuvant endocrine combination therapy and surgery. The trial aims to understand how well these treatments work and monitor their safety in this specific group. Participants will be assigned to one of several treatment groups receiving different combinations of inavolisib, letrozole, and ribociclib. Treatments are given orally once daily in cycles lasting 21 or 28 days. Some arms start with two drugs before adding the third, while others begin with the three-drug combination. Treatment continues through six cycles, with dosing schedules varying slightly between cycles. During the study, participants will undergo regular assessments including tumor response evaluations, Ki-67 biomarker measurements, and patient-reported outcomes about symptoms and treatment side effects. Researchers will monitor adverse events from the first dose until 30 days after the last dose, about eight months total. Participants will also have breast surgery after completing neoadjuvant treatment unless the cancer is inoperable. The study includes multiple visits for treatment and monitoring throughout the treatment period.

Researchers are evaluating whether adding Acalabrutinib to the standard R-miniCHOP chemotherapy can improve progression-free survival in older adults with untreated diffuse large B-cell lymphoma DLBCL. This phase 3, randomized trial compares outcomes of patients receiving R-miniCHOP alone with those receiving R-miniCHOP plus Acalabrutinib. The study focuses on individuals 61 years and older who are ineligible for full-dose R-CHOP treatment. Participants will be randomly assigned to one of two groups one receiving 6 cycles of R-miniCHOP plus 2 doses of Rituximab, and the other receiving the same regimen combined with Acalabrutinib taken orally twice daily for 8 cycles. The chemotherapy cycles are repeated every 3 weeks, and the study is open-label, meaning both participants and researchers know which treatment is given. During the trial, participants will undergo regular assessments to monitor disease progression, survival, remission rates, and adverse events for up to 5 years. Researchers will evaluate blood tests, physical exams, and other health parameters to measure outcomes such as progression-free survival, overall survival, event-free survival, and treatment safety. The study aims to provide detailed information on long-term effects and treatment tolerability in this older patient population.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

This research aims to collect treatment data on the new Plasma Filter PX2 used in therapeutic plasma exchange TPE for patients with autoimmune diseases. The study evaluates the plasma filters performance when combined with the multiFiltrate and multiFiltratePRO devices during TPE treatments. The single-group design reflects everyday clinical practice and seeks to contribute empirical evidence on the devices use without altering patients treatment plans. Participants will receive TPE treatments using the investigational Plasma Filter PX2 alongside the multiFiltrate or multiFiltratePRO devices. Treatments are conducted according to clinical standards established at each center and prescribed by the treating physician. The study does not define a fixed treatment schedule and includes documentation of up to ten TPE treatments per participant. During the study, researchers will collect detailed information about the TPE treatments, including therapy parameters over an average period of about seven weeks depending on individual indications and treatment frequency. Participants will be monitored for treatment data collection, and safety assessments like pregnancy testing will be conducted as needed. The studys total duration spans from treatment documentation through to study completion, supporting a comprehensive evaluation of the Plasma Filter PX2.

Researchers are evaluating the safety and effectiveness of combining two drugs, loncastuximab tesirine and epcoritamab, in patients with relapsed or refractory aggressive B-cell lymphoma, including diffuse large B-cell lymphoma DLBCL, high-grade B-cell lymphoma HGBL, and follicular lymphoma grade 3B. The study includes patients who have not received CAR-T cell therapy but failed first-line treatment, as well as those who have had CAR-T therapy and experienced failure. This is a phase II clinical trial aiming to assess toxicity and response rates in these patient groups. Participants receive loncastuximab tesirine intravenously with an initial dosing schedule followed by maintenance doses every 21 days in responding patients for up to six cycles. Epcoritamab is given as a subcutaneous injection with a step-up dosing during the first cycle, then weekly in cycles 2 and 3, biweekly in cycles 4 to 9, and monthly from cycle 10 to a maximum of 13 cycles. The trial includes a safety analysis after 20 patients start treatment and an interim efficacy analysis after 50 patients are recruited, with additional response assessments for CAR-T naive patients. During the study, participants undergo regular assessments including imaging by FDG-PETCT or MRI to evaluate tumor response, laboratory tests for organ function, and monitoring of adverse events up to 150 days after the last drug administration. The primary outcome is the best overall response rate measured 12 months after starting therapy. Secondary outcomes include progression-free and overall survival, response duration, and treatment-related safety events. The trial may last until April 2030, with 120 participants expected to be enrolled.