Bad Saarow

Researchers are conducting a phase II, multicenter, open-label trial to investigate the combination of Fruquintinib and Tislelizumab in patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) metastatic colorectal cancer who do not have active liver metastases. The study aims to evaluate the effectiveness of this combination in comparison to a control treatment for this specific group of patients. Participants will be randomly assigned to one of two treatment groups. The experimental group will receive oral Fruquintinib (5 mg daily for 21 days in each 28-day cycle) along with intravenous Tislelizumab (400 mg every 42 days). The control group will be treated with oral Trifluridine/tipiracil (35 mg/m2 twice daily on days 1-5 and 8-12 of each 28-day cycle) plus intravenous Bevacizumab (5 mg/kg every 14 days). Treatment continues until disease progression, unacceptable side effects, patient choice, or a maximum of 15 months. During the study, patients will undergo regular assessments including imaging to monitor disease status and safety evaluations. Follow-up will continue for up to 18 months after the last patient enrolls or until death, withdrawal, or loss to follow-up. The main outcome measure is the efficacy of Fruquintinib combined with Tislelizumab in this patient population over a 54-month period.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating treatments for patients with high risk chronic lymphocytic leukemia (CLL), a common and aggressive form of leukemia. This phase 3, open-label, randomized study aims to compare a triple combination therapy of acalabrutinib, obinutuzumab, and venetoclax (GAVe) against a double combination of obinutuzumab and venetoclax (GVe) to see which better prolongs progression-free survival (PFS). High risk CLL patients are identified by specific genetic risk factors such as 17p-deletion, TP53-mutation, complex karyotype, or unmutated IGHV gene status, which indicate a poorer prognosis and less response to chemotherapy. Participants receive fixed-duration treatments. The triple combination group receives obinutuzumab via intravenous infusion during cycles 1 through 6, venetoclax orally with a gradual dose ramp-up from cycle 1 to 12, and acalabrutinib orally twice daily during cycles 15 to 24. The comparison group receives obinutuzumab and venetoclax on the same schedules but without acalabrutinib. The study investigates how adding the BTK inhibitor acalabrutinib to the existing combination may improve outcomes by targeting different pathways and reducing early disease progression. During the study, participants are closely monitored for progression-free survival over 50 months after the first patient is included. Researchers assess clinical status, laboratory tests, and genetic markers to evaluate response and safety. The study also tracks liver and kidney function, infection status, and adverse events to ensure treatment tolerability. The total duration includes initial treatment cycles and extended follow-up to measure the long-term effectiveness of these therapies in high risk CLL patients.

Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management in real-world settings.

Researchers are collecting data on patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, a type of blood cancer classified by the WHO in 2008 and 2016. The study aims to register many patients at participating centers to better understand the disease by analyzing biological features and clinical outcomes, including quality of life. The research also focuses on identifying prognostic and predictive markers by correlating disease characteristics with patient results. Participants will be part of a registry study where samples such as bone marrow aspirates, blood, plasma, buccal swabs, and occasionally skin biopsies are collected and stored. Morphologic and genetic analyses will be performed on these samples. There is no intervention treatment; instead, the study gathers extensive clinical and biological data over time to support research. During the study, patients' clinical characteristics, quality of life, and outcome data will be assessed using specific questionnaires and defined clinical variables. Researchers will monitor treatment decisions, response to therapy, survival rates, and progression-free survival for up to 25 years. This long-term follow-up allows comprehensive tracking of the disease course and patient well-being.

This research focuses on sarcomas, which are rare malignant tumors affecting people of all ages and include over 80 different soft tissue sarcoma subtypes. It also includes carcinosarcomas (CS), tumors with characteristics of both epithelial and mesenchymal origins, which tend to be more aggressive. Due to the rarity and complexity of these tumors, information on their clinical course and best treatments is limited. The registry aims to collect extensive data on sarcoma and CS patients treated in Germany to better understand these diseases and improve treatment strategies. The registry is open and modular, aiming to include as many German sarcoma and CS patients as possible. Basic data are collected for every patient, with additional detailed information gathered for specific groups to address scientific questions, such as the effectiveness and side effects of systemic therapies. Data collection can be either prospective or retrospective depending on the sub-project within the registry. Participants' information includes treatment details and outcomes, with monitoring of incidence, prevalence, and prognosis of sarcoma subtypes over one year. The registry collects comprehensive data to track trends and changes in diagnosis and therapy practices over time. Participants contribute data through informed consent and follow-up, helping researchers evaluate treatment effects and disease progression in sarcoma and CS patients.

Researchers are collecting detailed information on adults diagnosed with Acute Lymphoblastic Leukemia (ALL) and related blood cancers such as other leukemias and certain types of Non-Hodgkin's Lymphoma. The purpose is to gather real-world data on diagnosis, treatments, and outcomes to support ALL research and improve quality of care. This registry includes patients whether or not they are part of other clinical trials. Participants included in this registry are adults aged 18 and older diagnosed with ALL or similar leukemias who are treated according to established ALL treatment protocols. It also includes patients with specific subtypes of Non-Hodgkin's Lymphoma treated according to B-ALL protocols. The study involves collecting clinical data and biological samples over time to understand treatment responses and disease progression. Throughout the study, researchers will monitor participants' health outcomes, including overall survival for up to 10 years. Data collected will cover diagnostics, treatments received, and patient outcomes in routine clinical care. This long-term follow-up aims to provide valuable insights into the effectiveness of current therapies and patient experiences with these blood cancers.