Kerpen

Researchers are evaluating the effectiveness of delgocitinib cream 20 mgg applied twice daily compared to a cream vehicle in treating adults with mild to severe palmoplantar pustulosis PPP. This trial is a phase 2a, double-blind study focusing on this skin condition characterized by pustules on the palms and soles. The main goal is to see how well delgocitinib cream improves symptoms over a 16-week treatment period. Participants will be randomly assigned to one of two groups one group will apply delgocitinib cream twice a day for 16 weeks, while the other group will use a matching vehicle cream twice daily for the same duration. The study includes a total of approximately 18 weeks for each participant, involving around 9 visits. The trial compares the active cream to the placebo cream to assess efficacy and safety. During the study, participants will attend scheduled visits to monitor their condition and collect data on skin symptoms, pustule counts, and quality of life measures. Researchers will assess the improvement in PPP severity using specific scales such as the PPP Area and Severity Index PPPASI. Safety is monitored through reports of any treatment-emergent side effects. Overall participation lasts about 18 weeks, including screening and treatment phases.

This research aims to improve treatment for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial is a large, international, randomized clinical study involving multiple countries and specialized centers. It focuses on whether using dexamethasone instead of prednisone during the induction phase can reduce relapses in the central nervous system CNS, and for high-risk patients, whether an intensified treatment improves event-free survival compared to standard therapy. Participants are grouped by risk level based on disease characteristics like CNS involvement and genetic markers. All patients first receive a prednisone prephase, then are randomized to either standard induction with prednisone or experimental induction with dexamethasone. Treatment phases include consolidation, extra-compartment phases adjusted by risk group, reintensification for some groups, and maintenance therapy lasting up to 24 months. Patients with CNS involvement receive intensified intrathecal therapy without cranial irradiation. High-risk patients may undergo a second randomization to receive either standard or intensified treatment during later phases. During the study, patients undergo various treatments including chemotherapy drugs such as cyclophosphamide, methotrexate, and PEG asparaginase. Researchers monitor disease relapse involving the CNS and measure event-free survival over a maximum of 7.25 years. Secondary assessments include overall survival, treatment-related toxicity and mortality, adverse events, and molecular markers. The trial involves ongoing follow-up for safety and effectiveness outcomes throughout the study period, which can last several years.

Researchers are studying patients with newly diagnosed H3 K27M-mutant diffuse glioma to see if the drug dordaviprone ONC201 after standard radiotherapy can help extend overall survival and delay disease progression. This international Phase 3 trial is randomized, double-blind, and placebo-controlled to carefully evaluate treatment effects in this specific patient group. Participants must have a confirmed diagnosis of this glioma subtype and have completed frontline radiotherapy. Participants are randomly assigned to one of three groups dordaviprone taken twice weekly, dordaviprone taken once weekly, or a matching placebo. Dosing is adjusted based on body weight, with a standard dose of 625 mg for patients weighing 52.5 kg or more. The study treatment starts after completion of radiotherapy and continues under close monitoring. Throughout the study, participants undergo regular assessments including brain MRIs, laboratory tests, and evaluations of neurological function and quality of life. Researchers will monitor overall survival over approximately 44 months, as well as progression-free survival, corticosteroid use, performance status, and symptom changes. Safety and lab parameters will be tracked closely to understand treatment effects and participant well-being during the trial period.

This research aims to evaluate the effectiveness and safety of combining pembrolizumab with lenvatinib in women with vulvar squamous cell carcinoma VSCC that is recurrent, persistent, metastatic, or locally advanced and cannot be treated with surgery or radiation. This phase II, open-label, single-arm study focuses on patients who have limited treatment options due to the advanced nature of their cancer. Participants receive pembrolizumab 400 mg every six weeks along with daily doses of lenvatinib at 20 mg. The study monitors these treatments over time to assess their combined impact on the disease. This trial does not include a comparison group and follows patients through treatment to observe outcomes. During the study, patients undergo regular evaluations including scans to measure tumor response, lab tests, and assessments of quality of life. Researchers track the overall response rate within 24 weeks as the primary outcome and also evaluate disease control, duration of response, survival rates, and safety throughout treatment and up to 40 months. Adverse events and patient-reported outcomes are closely monitored to understand treatment effects and tolerability.

Researchers are evaluating the safety and effectiveness of trastuzumab deruxtecan T-DXd Enhertu4 combined with pembrolizumab compared to platinum-based chemotherapy combined with pembrolizumab for people with locally advanced unresectable or metastatic non-squamous non-small cell lung cancer NSCLC that overexpresses HER2 and has PD-L1 tumor proportion score less than 50%. Participants must not have received prior therapy for this condition and should not have known actionable genomic alterations with locally available treatments. Participants are randomly assigned to one of two treatment groups. One group receives T-DXd intravenously at 5.4 mgkg every three weeks plus pembrolizumab 200 mg IV every three weeks. The other group receives pemetrexed 500 mgm2 IV plus a platinum chemotherapy agent cisplatin 75 mgm2 or carboplatin AUC 5 mgmLmin IV every three weeks along with pembrolizumab 200 mg IV every three weeks. Treatments continue as first-line therapy for advanced or metastatic disease. During the study, participants will have tumor tissue samples assessed for HER2 and PD-L1 expression. Researchers will monitor progression-free survival by imaging review up to about 54 months and overall survival up to about 85 months. The trial is open-label and randomized, with assessments including safety monitoring and efficacy evaluations. Participants are followed throughout treatment and for a long-term period to measure outcomes related to disease progression and survival.