Bad Saarow

This trial investigates treatment options for patients with microsatellite stable MSS or proficient mismatch repair pMMR metastatic colorectal cancer who do not have active liver metastases. It is a phase II, prospective, randomized, open-label study conducted across multiple centers. The study aims to evaluate the effectiveness of Fruquintinib combined with Tislelizumab compared to a control treatment in this specific patient group. Participants will be randomly assigned to one of two groups. One group will receive Fruquintinib orally once daily for 21 days in a 28-day cycle along with Tislelizumab given intravenously every 42 days. The other group will receive Trifluridinetipiracil orally twice daily on specific days of a 28-day cycle plus Bevacizumab intravenously every 14 days. Treatment will continue until disease progression, unacceptable side effects, patient choice, or a maximum of 15 months. During the study, patients will undergo regular assessments including imaging scans to monitor disease status, evaluations of side effects, and quality of life measures. Follow-up will continue for up to 18 months after the last patient begins treatment or until death, withdrawal, or loss to follow-up. Researchers will primarily measure the efficacy of the Fruquintinib and Tislelizumab combination, along with overall survival, response rates, safety, and quality of life.

Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer mNSCLC whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab in patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. A separate study arm will assess rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, sponsor-blinded clinical trial conducted globally at about 200-250 sites in approximately 25 countries. Participants will be assigned to one of three treatment groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Most drugs are administered by intravenous infusion every three weeks, except capecitabine, which is given orally twice daily. The study compares the effects of these combinations as first-line treatments. Participants will be monitored for up to approximately six years to measure outcomes such as progression-free survival and overall survival. Other assessments include response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and impact on feeding and side effect burden. The study includes regular evaluations of tumor status using RECIST criteria, organ function, cardiac function, and collection of tumor tissue samples. Safety and treatment effects will be followed closely throughout the study duration.

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 studying vepugratinib, a new medicine, to see if it is safe and helpful for people with advanced or metastatic bladder cancer that has a specific FGFR3 genetic alteration. This phase 3 study compares vepugratinib combined with enfortumab vedotin and pembrolizumab against a placebo combined with the same drugs. The trial aims to evaluate safety and effectiveness over a long period. Participants receive either vepugratinib or placebo orally, along with enfortumab vedotin and pembrolizumab administered by intravenous infusion. There is a safety lead-in period and then randomized treatment groups. The study is double-blind and placebo-controlled, with treatment continuing for up to about 6 years. During the study, participants will have regular assessments to monitor treatment safety, responses, and disease progression. Researchers will measure adverse events, overall response rates, progression-free survival, and quality of life using standard criteria. Blood samples will be taken to check drug levels. The trial includes long-term follow-up to observe outcomes and side effects over time.

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.

This research aims to collect comprehensive data on sarcomas and carcinosarcomas CS, rare malignant tumors affecting people of all ages, including over 80 subtypes of soft tissue sarcomas. The study focuses on understanding the clinical course and treatment outcomes of these diverse tumors, especially the aggressive mixed sarcomatoidepithelial tumors called carcinosarcomas. The registry seeks to capture data from patients treated in Germany to improve knowledge of diagnosis, treatment, and disease progression over time. Participants with verified bone or soft tissue sarcomas, including tumors with borderline or unclear histological features, as well as carcinosarcomas, are included regardless of their therapy type or treatment stage. Data collection can be prospective or retrospective and involves a basic dataset for every patient, with additional detailed information gathered in specific sub-projects focused on scientific questions like therapy effectiveness and adverse effects. Throughout the study, patient data on treatments and outcomes are recorded to identify trends and inform best practices. Researchers monitor the incidence, prevalence, and prognosis of sarcoma subtypes annually. Participation involves providing informed consent, and data collection may include medical records and other relevant information. The studys duration allows ongoing data aggregation and analysis to capture the evolving treatment landscape for sarcoma and carcinosarcoma patients.

Researchers are collecting information on adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases like certain types of Non-Hodgkins Lymphoma. This observational registry gathers data from routine clinical care to support research and improve quality assurance. The study includes adults treated according to ALL or related treatment protocols, whether they are part of a clinical trial or not. This registry does not involve any specific treatments but collects detailed data on diagnosis, treatment, and outcomes. It prospectively gathers information on patient progress, including survival and remission rates, as well as biomaterial samples when available. The study monitors various types of leukemia and lymphoma subtypes treated under ALL protocols. Participants contribute by allowing their medical data and biomaterial to be collected and analyzed over time. Researchers track many outcomes such as overall survival, remission status, relapse rates, quality of life, and treatment-related side effects. Follow-up can extend up to 10 years, with ongoing evaluations to understand long-term health and treatment effects.

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.