Delft

Researchers are investigating treatments for adults with metastatic breast cancer that is estrogen receptor-positive, HER2-negative, and expresses gastrin releasing peptide receptor (GRPR). This study focuses on patients who have experienced disease progression after endocrine therapy combined with CDK4/6 inhibitors. The trial aims to find the best doses and schedules of [177Lu]Lu-NeoB combined with capecitabine and to evaluate the preliminary anti-tumor activity of this combination in this patient population. Participants will receive [177Lu]Lu-NeoB, a radioligand therapy, along with capecitabine, a chemotherapy drug. The study includes a phase I dose escalation to determine recommended doses, starting with 150mCi of [177Lu]Lu-NeoB every 6 weeks and capecitabine given twice daily for 14 days followed by 7 days off. Depending on safety, different dose levels and schedules will be explored. Phase II will randomize participants to treatment regimens based on phase I results. Imaging with [68Ga]Ga-NeoB PET/CT or PET/MRI will be performed during screening and after treatment in phase II to assess tumor GRPR expression. Participants will attend study visits approximately every 3 weeks for the first 9 months, then every 6 weeks, for treatment administration, safety monitoring, and tumor assessments. Tumor scans occur every 9 weeks until month 18, then every 12 weeks until month 36, and as needed afterwards. After stopping treatment, safety follow-up lasts 8 weeks, with longer-term follow-up for up to 5 years. Researchers will monitor safety, dose tolerability, tumor response, progression-free and overall survival, and other outcomes related to treatment effectiveness and side effects.

Researchers are evaluating overall survival in men with metastatic castration-resistant prostate cancer (mCRPC), a form of prostate cancer that has spread beyond the prostate and no longer responds to hormone therapies. This Phase 3 randomized trial compares pasritamig (JNJ-78278343), a T cell redirecting agent targeting human kallikrein 2, combined with best supportive care (BSC), against placebo with BSC to understand the length of time participants survive from the start of treatment. Participants receive pasritamig or placebo through intravenous infusion along with best supportive care, which is provided at the treating physician's discretion. The study focuses on men who have previously undergone multiple prostate cancer treatments including androgen-receptor pathway inhibitors, taxane chemotherapy, radioligand therapy, and possibly PARP inhibitors. Patients must continue ongoing hormone therapy during the treatment phase. During the study, participants are monitored for overall survival up to 2 years and 8 months. Assessments include clinical evaluations and laboratory tests to measure kidney and liver function, blood counts, and general health status. Safety and treatment effects are closely observed, with eligibility based on performance status and organ function. The trial aims to provide detailed long-term outcome data for this advanced prostate cancer treatment approach.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Researchers are investigating the effects of PKN605, an oral medication, on reducing the burden of atrial fibrillation in adults diagnosed with this heart rhythm disorder. This Phase 2, randomized, placebo-controlled, and double-blinded study aims to evaluate how well PKN605 works, as well as its safety, tolerability, and how the body processes the drug. Participants must have a history of atrial fibrillation or flutter and meet certain clinical criteria for inclusion. The study begins with a screening period lasting up to 90 days to determine eligibility. After this, participants are randomly assigned to receive either PKN605 or a matching placebo. The treatment phase lasts 24 weeks, during which participants visit the clinic about once a month. Atrial fibrillation is closely monitored throughout the study using various ECG devices. Approximately one month after the treatment ends, a final safety follow-up visit is conducted. Participants will be involved in regular clinic visits for assessments, including ECG evaluations to measure atrial fibrillation burden. Researchers will track how much time participants spend in atrial fibrillation using ECG patch monitors over 24 weeks. Safety and tolerability are also monitored throughout the study. The total participation time includes the screening, treatment, and follow-up phases, providing comprehensive data on the effects and safety of PKN605.

The BioDay Registry collects real-world data on the safety and effectiveness of new systemic treatments such as biologics and Janus kinase inhibitors in patients with atopic dermatitis. It also investigates how these treatments affect other related allergic conditions like food allergies, asthma, and conjunctivitis. This multicenter registry aims to provide valuable information for daily clinical practice. The registry includes several modules focused on different atopic comorbidities to capture comprehensive patient data during biologic treatment. It observes patients treated with new systemic therapies over time in a real-world setting without assigning specific interventions. Participants provide information through questionnaires and regular assessments to track treatment effects and side effects. Researchers monitor changes from baseline at several time points, including 16 weeks, 1 year, and 2 years, and analyze how long patients continue their prescribed treatments. The study includes both adults and children and follows them prospectively to gather long-term safety and effectiveness data.

Researchers are evaluating the Corsano CardioWatch 287-2, a wearable medical device designed to continuously and non-invasively monitor blood pressure using optical photoplethysmography (PPG). This study focuses on patients with hypertension who have uncontrolled blood pressure and require initiation, increase, or change of antihypertensive medication. The trial aims to assess the device's ability to track blood pressure reductions during 28 days of treatment compared to standard automatic cuff measurements, addressing the need for accurate remote blood pressure monitoring. Participants will wear the Corsano CardioWatch 287-2 device continuously for 28 days while starting or adjusting their blood pressure medications. Blood pressure measurements from the CardioWatch will be compared with those taken by an automatic blood pressure cuff at the start and end of the study. The device measures various vital signs including pulse rate, ECG, oxygen saturation, skin response, body temperature, and non-invasive blood pressure. The study involves outpatient cardiology clinic patients with uncontrolled hypertension. During the 28-day period, blood pressure will be recorded continuously by the CardioWatch and spot-checked using the cuff. Researchers will analyze baseline and post-treatment blood pressure and compare the changes measured by both devices. The primary outcomes include average systolic and diastolic blood pressure decreases after treatment. Participants will provide consent and be monitored for device tolerance and adherence. This study is designed to improve remote monitoring options for patients undergoing blood pressure treatment.

Researchers are evaluating treatment options for patients with early-stage classical Hodgkin lymphoma who have not received prior therapy. This international phase III trial runs two parallel studies in different regions, combining data to better understand treatment effects. The trial compares two chemotherapy regimens, ABVD and A2VD, with treatment adapted based on PET-CT scan results after two cycles to guide further therapy. Participants will be randomly assigned to receive either ABVD chemotherapy (doxorubicin, bleomycin, vinblastine, and dacarbazine) or A2VD chemotherapy (doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support). PET-CT scans are performed after one cycle for exploratory purposes and after two cycles to determine subsequent treatment. Depending on PET results, patients may receive additional chemotherapy cycles or involved site radiotherapy following ILROG guidelines. Those with poor response discontinue trial treatment and receive alternative therapy. During the study, patients undergo PET-CT scans and regular assessments to monitor treatment response and safety. Follow-up continues for at least five years after treatment completion to assess progression-free survival. Researchers collect clinical data and imaging results to evaluate outcomes, with central review of PET scans guiding treatment adaptations. Participants are monitored for side effects and overall health throughout the trial period.

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the feasibility and safety of permissive lung-protective ventilation in critically ill adults who require invasive mechanical ventilation due to acute hypoxemic respiratory failure. This pilot study aims to inform the design of a future larger randomized clinical trial. The study compares a lower respiratory rate ventilation strategy that allows mild hypercapnia with a conventional lung-protective ventilation approach maintaining normal blood gas levels. Both strategies are considered standard care in intensive care units, and the study focuses on patients expected to be ventilated for more than 24 hours. Participants are randomly assigned to one of two groups. The intervention group receives permissive lung-protective ventilation, where the respiratory rate is gradually reduced stepwise, guided by arterial blood gas analysis and continuous carbon dioxide monitoring, targeting a partial pressure of carbon dioxide up to 8.5 kPa and arterial pH above 7.20. The respiratory rate is decreased every 10 minutes until reaching a minimum of 4 breaths per minute, continuing until spontaneous breathing begins. The control group follows conventional lung-protective ventilation with respiratory rates adjusted to maintain normal carbon dioxide and pH levels. Blood gas analyses are performed hourly for six hours after randomization and then every eight hours during nursing shifts. During the study, patients are monitored from the start of mechanical ventilation until the first extubation for up to 28 days. Researchers collect demographic, ventilation, and outcome data without additional harm beyond standard care. Safety is assessed by monitoring for unacceptable hypercapnia, hypoxemia, and ventilator-associated complications. The primary outcome is the feasibility of the intervention, measured by the difference in respiratory rates between groups. Secondary measures include protocol compliance and data collection feasibility. The total participation duration depends on ventilation length and clinical progress.