Bingen Am Rhein

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating the effects of Dato-DXd combined with osimertinib or Dato-DXd alone compared to platinum-based doublet chemotherapy in people with EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC whose disease progressed after prior osimertinib treatment. This Phase III, open-label, randomized study aims to compare progression-free survival among these treatments to better understand options for this condition. Participants are randomly assigned to one of three groups Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd is given as an intravenous infusion every 3 weeks, osimertinib is taken orally daily, and chemotherapy involves pemetrexed combined with carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance pemetrexed. Treatments continue until disease progression, unacceptable side effects, or other reasons to stop. Throughout the study, participants undergo regular assessments including radiological scans to monitor tumor response using RECIST v1.1 criteria, safety evaluations, and health status measurements. After stopping treatment, an end-of-treatment visit occurs within 35 days, followed by safety follow-up 28 days after the last dose. The study primarily measures progression-free survival over up to 2.5 years, with additional outcomes including overall survival, response rates, quality of life, and pharmacokinetics monitored for up to 3.5 years.

Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are investigating treatment options for Waldenstrf6ms macroglobulinemia WM, a condition where chemotherapy often results in low complete or very good partial response rates and limited duration of response. WM patients tend to be older and may not tolerate chemotherapy side effects well, so treatments without chemotherapy are especially appealing. Venetoclax, a drug approved for related blood cancers, has shown promising activity and low toxicity in WM patients, including those previously treated with Ibrutinib or with certain genetic mutations. Ibrutinib, while effective, requires continuous use and its success varies with genetic factors, limiting its adoption as a standard treatment. Fixed-duration treatment combining Venetoclax and Rituximab has shown deep responses in related diseases, suggesting it might improve outcomes for newly diagnosed WM patients. The study is an international, phase II, open-label, randomized trial comparing two treatment approaches for newly diagnosed WM patients needing therapy. One group receives a combination of Venetoclax and Rituximab, with Venetoclax dose gradually increased during the first 28-day cycle and continued for 12 cycles alongside Rituximab given intravenously monthly. The other group receives a combination of Dexamethasone, Rituximab, and Cyclophosphamide for six 28-day cycles. The study uses genetic markers MYD88 and CXCR4 to stratify patients before randomization. About 80 patients will participate across multiple sites. Participants will be monitored for treatment response and safety during and after therapy, with assessments including response rates at 12 and 24 months, progression-free survival over six years, and quality of life measured by questionnaires. Safety evaluations involve tracking adverse events, laboratory tests, heart monitoring, and vital signs over 12 months. The main goal is to see if Venetoclax plus Rituximab leads to better deep response rates compared to the standard chemotherapy combination. This trial aims to provide data supporting new treatment standards for WM.

This research aims to gather a large group of patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, classified according to WHO 20082016 standards. The study focuses on collecting detailed clinical, biological, and quality-of-life data to better understand disease characteristics, outcomes, and potential prognostic markers. It is an observational registry conducted by the University of Ulm to improve knowledge about this condition over time. Participants in this registry will provide various biological samples, such as bone marrow aspirate, peripheral blood, plasma, buccal swabs, and occasionally skin biopsies. These samples will be used for morphological and genetic analysis. The study does not involve any experimental treatments but collects comprehensive data and samples to assess disease features and clinical outcomes. Throughout the study, researchers will collect clinical information using a defined catalog of relevant variables and assess quality of life with specific symptom assessment forms. They will track outcomes including treatment decisions, responses, overall survival, progression-free survival, and duration of response for up to 25 years. This long-term follow-up allows detailed monitoring of patient health and disease progression.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation ASCT. The study compares a combination of iberdomide and isatuximab with iberdomide alone to determine if adding isatuximab reduces measurable myeloma cells in the bone marrow after two years. This is a multicenter, randomized, open phase III trial building on prior treatments from the GMMG-HD8DSMM XIX trial or similar regimens. Participants are randomly assigned to one of two groups. One group receives oral iberdomide alone for 39 cycles, each lasting 29 days, with dexamethasone added during the first cycle. The other group receives the same iberdomide regimen plus subcutaneous isatuximab injections using a wearable injector system, with dexamethasone also given in the first cycle. Treatment continues for up to 36 months. Randomization considers factors like minimal residual disease MRD status and the number of transplantations. During the study, participants will undergo bone marrow assessments to measure MRD using next-generation flow cytometry. Researchers will monitor progression-free survival, overall survival, response rates, and quality of life using validated questionnaires. Safety and treatment effects will be followed for up to five years after randomization. Participants will have regular evaluations including laboratory tests and clinical assessments throughout the maintenance period and follow-up.

Researchers are evaluating the effectiveness and safety of two treatment strategies for patients newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This international, multicenter, randomized, open Phase III trial compares carboplatinpaclitaxel chemotherapy followed by niraparib alone versus carboplatinpaclitaxel combined with bevacizumab followed by both bevacizumab and niraparib. The study includes patients with high-grade, non-mucinous, non-clear cell epithelial tumors at specific advanced stages who have had surgery or plan chemotherapy with interval debulking surgery. All patients receive an initial cycle of carboplatin and paclitaxel before randomization. After central testing of tumor BRCA status, participants are randomly assigned to one of two arms Arm 1 continues with five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years Arm 2 receives five cycles of carboplatin and paclitaxel plus bevacizumab, then maintenance bevacizumab for up to one year alongside daily niraparib for up to three years. This design aims to determine if adding bevacizumab improves outcomes over the standard treatment. Participants undergo frequent assessments including scans and laboratory tests to monitor progression-free survival and other health outcomes. Researchers also evaluate overall survival, time to additional therapies, treatment-related side effects, and quality of life up to several years after enrollment. Patients attend regular visits for treatment, monitoring, and completion of questionnaires, with safety follow-up 30 days after the last dose. The entire observation period can last up to 66 months after the last patient joins the trial.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.