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Researchers are evaluating whether the introduction of dedicated hospital-based HIV teams can improve HIV testing rates among patients with HIV indicator conditions across ten European countries. This real-world, multicenter, stepped-wedge cluster randomized effectiveness-implementation trial spans four years and involves hospitals in the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. The study aims to address the current gap in HIV testing and improve early diagnosis by comparing testing rates before and after the implementation of HIV teams. The intervention involves creating local HIV teams led by HIV specialists, supported by nurses and data collectors. These teams focus on auditing and providing feedback to healthcare professionals to encourage HIV testing when indicated, reducing stigma, educating staff on HIV prevention and care, and improving linkage to local prevention services. The HIV teams use electronic health records to identify patients with HIV indicator conditions and integrate their activities into routine hospital care. Participants' data are collected retrospectively from routine care and prospectively at the healthcare professional level. Researchers measure changes in HIV testing rates, new HIV diagnoses, and variations across countries and specialties. They also assess the HIV diagnosis and care cascade, healthcare professionals' knowledge and stigma levels, and implementation outcomes such as resource use and cost-effectiveness. Monitoring includes feedback loops and evaluation of barriers and facilitators to implementation, aiming to improve HIV testing and care sustainability in hospitals.

Researchers are studying a new treatment combination for adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and GRPR positive. The trial aims to find the recommended dose of the drug [177Lu]Lu-NeoB when given with ribociclib and fulvestrant to participants who have experienced early relapse after endocrine therapy or whose disease has progressed after endocrine therapy combined with a CDK4/6 inhibitor. This Phase 1 study includes a dose escalation part and a backfill part to assess safety, tolerability, and preliminary effectiveness. Participants will receive [177Lu]Lu-NeoB once every 28-day cycle for six cycles, ribociclib daily on days 1 to 21 of each cycle, and fulvestrant on specific days beginning at cycle 1. Pre- or perimenopausal women and men will also receive goserelin. The trial includes imaging with the radioactive agent [68Ga]Ga-NeoB at screening, possibly at cycle 2 day 15, and again 4 to 8 weeks after the last dose of [177Lu]Lu-NeoB to help locate cancer lesions. During the study, participants visit the clinic regularly for treatment, safety checks, and tumor assessments. Safety follow-up continues for 8 weeks after treatment ends, with extended monitoring every 12 to 24 weeks for up to 5 years to track side effects, adverse events, and treatment interruptions. Researchers will closely observe any dose-limiting toxicities and evaluate overall safety and effectiveness throughout the study period.

Researchers are studying intismeran autogene combined with pembrolizumab to see if it can stop advanced melanoma, a type of skin cancer that has spread and cannot be removed by surgery, from growing or spreading. This Phase 2 study compares this combination to pembrolizumab with a placebo, aiming to find out if the new treatment helps people live longer without cancer progression. Immunotherapy, which helps the immune system fight cancer, is a standard treatment for advanced melanoma, and intismeran autogene is designed to boost the immune response against a person's specific cancer. Participants receive either intismeran autogene or a placebo through intramuscular injection, along with pembrolizumab given as an intravenous infusion. The study is randomized, double-blind, and controlled, meaning neither participants nor researchers know who gets the active treatment or placebo. This design helps to better understand the effects of intismeran autogene when combined with pembrolizumab. During the study, researchers will monitor participants for up to about 36 months to measure progression-free survival, which means the length of time participants live without the cancer worsening. Assessments include imaging scans to track tumor changes, tumor tissue collection for biomarker analysis, and documentation of any side effects. Participants may also have their mutation status checked and will be observed for safety throughout the study period.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are studying the safety and early effectiveness of a new cell therapy called CLDN6 CAR-T, with or without an RNA-based vaccine, in patients who have CLDN6-positive advanced solid tumors that have returned or not responded to prior treatments. This Phase I, first-in-human, open-label trial involves multiple sites and focuses on patients with tumors expressing the CLDN6 protein at a high level. The study aims to find the best dose of these therapies and gather initial evidence of their activity against these difficult cancers. The trial has two main parts. The first part tests increasing doses of CLDN6 CAR-T cells made using manual and automated processes to determine the maximum tolerated dose or recommended dose for future studies. The second part adds the CLDN6 RNA-based vaccine to the CAR-T cells, exploring dose levels to optimize treatment effects. The CAR-T cells and RNA vaccines are given through intravenous infusions or injections at scheduled times. An optional dose decrease may be evaluated to further assess safety and effectiveness. Participants will be followed for up to 25 months in the main trial, with ongoing assessments of side effects, dose adjustments, and treatment tolerability. After the main study, patients may join a long-term follow-up period lasting up to 15 years to monitor delayed effects and long-term outcomes. Researchers will collect medical information through scans, lab tests, and clinical evaluations to measure safety events, including serious and dose-limiting toxicities, as well as treatment responses over time.

Researchers are studying oligodendrogliomas, a type of brain tumor identified by specific genetic changes such as IDH1 or IDH2 mutations and 1p/19q co-deletion. These tumors are classified as CNS WHO grade 2 or 3, and the study aims to determine the best treatment approach to improve survival while preserving brain function and quality of life. This phase 3 trial compares current standard treatments because existing data is unclear about the best timing and combination of chemotherapy and radiotherapy for these tumors. The study compares two treatment approaches for adults with newly diagnosed grade 2 or 3 oligodendrogliomas. One group receives an initial chemotherapy regimen of lomustine and temozolomide (CETEG) with delayed radiotherapy plus PCV chemotherapy at progression. The other group receives standard radiotherapy followed by PCV chemotherapy. Radiotherapy doses vary based on tumor grade. The study plans to assess if delaying radiotherapy and adjusting chemotherapy can maintain survival while reducing side effects. Participants will undergo regular monitoring including MRI scans every three months, neurological assessments, quality of life questionnaires, and annual cognitive testing. Researchers will measure qualified overall survival, defined as survival without decline in function, cognition, or quality of life. The study will last up to 10 years, with close tracking of side effects, tumor response, and patients' well-being to determine the best balance of treatment effectiveness and quality of life.

This research aims to evaluate the safety, blood levels, and antiviral activity of the antibody BNT351 in adults living with and without HIV. The study is a Phase I clinical trial designed to assess how well BNT351 is tolerated, its side effects, and its impact on HIV levels in people living with HIV (PLWH). It includes two parts: Part A involving people without HIV and Part B involving people with HIV who have detectable virus levels. Part A is a randomized, double-blind, placebo-controlled study with a single ascending dose design. It will enroll HIV-negative participants into four cohorts receiving either subcutaneous or intravenous doses of BNT351 or placebo. Part B is an open-label, single-dose proof-of-concept study enrolling HIV-positive participants who will receive BNT351 and be observed before starting combination antiretroviral therapy (cART). Part A participants undergo about a 4-week screening, dosing, and approximately 38 weeks of follow-up. Part B participants have about a 4-week screening, dosing, and up to 8 weeks of observation before starting cART, with total follow-up lasting about 38 weeks post-treatment. Participants will have regular assessments including safety monitoring for adverse events and infusion reactions, blood tests for drug levels and HIV viral load, and immune cell counts. HIV viral load will be closely measured at multiple points before cART initiation in Part B. Researchers will track side effects, antibody concentration over time, and changes in HIV infection markers. Both parts last up to approximately 42 weeks per participant, with ongoing safety and viral activity evaluations throughout the study period.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the safety, tolerability, and effectiveness of Navepegritide (TransCon CNP) in infants diagnosed with achondroplasia, a genetic condition affecting growth. This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial involves infants aged from birth up to but not including 2 years, with genetically confirmed heterozygous achondroplasia. The study aims to monitor the growth impact and safety of weekly doses of Navepegritide over one year. Participants receive either 100 micrograms per kilogram of Navepegritide or a placebo, both administered as subcutaneous injections once per week for 52 weeks. This treatment period is followed by an open-label extension phase where participants may continue receiving the study drug. The trial compares the effects of the investigational drug against placebo to assess its tolerability and growth outcomes. Throughout the 52 weeks, infants will undergo regular medical evaluations including physical examinations, vital signs monitoring, ECGs, imaging, and laboratory tests. Researchers will track adherence to weekly injections and daily vitamin D supplementation where applicable. The primary outcomes focus on safety and growth effects of Navepegritide, with continuous monitoring to ensure participant well-being during the trial period.