Tubingen

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are studying MK-1084, a targeted therapy, to treat advanced or metastatic non-squamous non-small cell lung cancer NSCLC with a specific KRAS G12C mutation. The study aims to evaluate the safety and tolerability of MK-1084 when combined with other treatments, and to see how many participants experience tumor shrinkage or disappearance. This trial is part of a larger master protocol and includes participants who have previously received certain cancer therapies. Participants will receive MK-1084 combined with either patritumab deruxtecan HER3-DXd or sacituzumab tirumotecan Sac-TMT until treatment is stopped due to side effects, adverse events, or investigator decision. MK-1084 is taken orally, while the other drugs are given by intravenous infusion. The arm combining MK-1084 with cetuximab was discontinued per protocol amendment. Throughout the study, participants will undergo assessments to monitor dose-limiting toxicities, adverse events, and treatment response for up to approximately 63 months. Researchers will also evaluate progression-free survival and drug concentration levels in the blood. Safety and treatment effects will be closely tracked, and participants may receive rescue medications to manage symptoms like nausea. The total study duration extends to 2032, with primary outcome evaluation by 2029.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Many patients receiving radiation therapy for head and neck cancer develop painful mouth sores called oral mucositis, causing severe pain that lasts through and beyond treatment. This study evaluates whether BupiZenge, a lozenge containing the long-acting pain reliever bupivacaine, provides better pain control than lidocaine solution. The trial aims to see if improved pain management with BupiZenge enhances quality of life and reduces opioid use in adults aged 18 to 80 with head and neck cancer undergoing radiotherapy. Participants are randomly assigned to receive either BupiZenge lozenges or lidocaine oral solution. BupiZenge is taken as one lozenge that dissolves slowly in the mouth with a dosing interval of at least 3 hours, up to 8 lozenges per day. Lidocaine is used as an oral solution held in the mouth, also every 3 hours as needed, with a maximum daily dose of 120 mL. The study includes a combined screening and run-in period up to five weeks, followed by treatment during radiotherapy and for up to six weeks total if pain and sores persist after radiotherapy. Participants will record their mouth pain daily using a 0 to 10 scale, with primary measurement focusing on pain reduction over 3 hours after taking the study treatment on the last day of radiotherapy. Additional assessments include pain at other time points, opioid use, quality of life questionnaires, laboratory tests, and safety monitoring. After treatment, there is a 30-day follow-up period to evaluate lasting effects and safety outcomes.

Researchers are investigating treatments for oligodendrogliomas, a type of brain tumor classified by specific genetic markers including mutations in isocitrate dehydrogenase IDH and co-deletion of chromosomes 1p19q. This trial focuses on adults with newly diagnosed grade 2 or 3 gliomas, aiming to improve survival without loss of brain function, cognition, or quality of life. The study compares two treatment approaches to determine the best timing and combination of chemotherapy and radiotherapy. Participants are randomly assigned to receive either standard chemoradiation with procarbazine, CCNU lomustine, and vincristine PCV combined with radiotherapy, or an experimental approach starting with chemotherapy using lomustine and temozolomide CETEG followed by radiotherapy and PCV at tumor progression. Radiotherapy is delivered over about 5 to 6 weeks, with doses adjusted for tumor grade. Chemotherapy cycles last 6 weeks and include specified doses of oral and intravenous drugs. During the study, participants undergo regular magnetic resonance imaging MRI scans every three months, neurological assessments, quality of life questionnaires, and cognitive testing annually. The main outcome measured is qualified overall survival, which tracks survival without significant cognitive or functional decline. The study lasts up to 10 years, with ongoing monitoring of tumor progression, treatment response, and patient wellbeing. Safety and side effects are carefully assessed throughout the trial.

Researchers are evaluating the safety, effectiveness, optimal dose, and behavior of an investigational drug called BNT326, alone or combined with other immunotherapy agents, in adults with advanced solid tumors. This study includes patients with tumors that have either spread metastatic, returned after treatment, or progressed despite previous therapies, across various cancer types such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. Participants are divided into two parts Part 1 tests BNT326 alone in different tumor-specific groups, some with dose randomization to find optimal dosing. Part 2 evaluates BNT326 alone or combined with another investigational drug called pumitamig in several cancer types, with some groups receiving randomized doses and others non-randomized treatments. Treatments are given via intravenous infusion, with some oral medications combined in Part 1. The study includes dose escalation and randomization phases, and treatment can continue for up to 24 months or until disease progression or other reasons. During the study, participants undergo screening, treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring phases. Researchers assess adverse events, treatment responses, disease progression, and drug behavior in the body using clinical evaluations and laboratory tests. Follow-up assessments occur up to approximately 38 months for Part 1 and 48 months for Part 2, with continued treatment possible for those benefiting from the therapy. The study aims to gather comprehensive data on safety, dosing, and effectiveness in this patient population.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are comparing two psychotherapy programs, the Cognitive Behavioral Analysis System of Psychotherapy CBASP and Behavioral Activation BA, in adults with persistent depressive disorder PDD who have not responded well to previous treatments. This study focuses on hospitalized patients with treatment-resistant depression and aims to evaluate which therapy is more effective in reducing depressive symptoms over 16 weeks. The study also explores factors that affect treatment response and the long-term effects of these therapies. Participants will receive either CBASP or BA treatment during a 10-week acute phase consisting of inpatient or dayclinic therapy followed by a 6-week outpatient continuation phase with group therapy. Both therapies include individual and group sessions, nurse contacts, and exercise therapy during inpatient treatment. All patients will also receive optimized antidepressant medication according to standard guidelines, with adjustments if needed based on response. During the study, participants will undergo regular assessments using various depression rating scales, symptom inventories, and quality of life questionnaires from baseline through 64 weeks after treatment start. Researchers will monitor responses, remission, relapse rates, and cost-effectiveness of the treatments. The total study duration includes acute treatment, continuation therapy, and long-term follow-up to evaluate sustained outcomes and health economic impacts.

Researchers are evaluating the persistence of two treatments, upadacitinib UPA and tumor necrosis factor inhibitors TNFi, in adults with moderate to severe active rheumatoid arthritis RA. This observational study is conducted in Germany with about 678 participants across roughly 80 sites. The purpose is to compare how long participants continue their prescribed treatment under real-world conditions over time. Participants will receive either UPA or TNFi treatment as prescribed by their doctors, following local labels and standard care practices. Treatment decisions were made before joining the study and are independent of recruitment. The study will observe participants for up to 24 months to assess retention rates on these treatments. During the study, participants will be monitored regularly according to local care standards. Researchers will collect data on how long participants stay on their assigned treatment, focusing on retention rates over approximately 24 months. Study participation may last up to two years, with recruitment expected to take about 24 months, resulting in a total study duration of about 48 months.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.