Hoofddorp

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating pasritamig JNJ-78278343 combined with best supportive care BSC compared to placebo with BSC in men with metastatic castration-resistant prostate cancer mCRPC, a form of prostate cancer that has spread and no longer responds to hormone therapies. This Phase 3 randomized, double-blind study aims to assess overall survival, measuring how long participants live from the start of the study until death from any cause. Participants will be randomly assigned to receive either pasritamig or placebo through intravenous infusion. The dosing starts with step-up doses on Cycle 1 Day 1 and Day 8, followed by a target dose on Day 15. Subsequent cycles of treatment occur every 6 weeks, with Cycle 1 lasting 8 weeks and later cycles lasting 6 weeks each. All participants may also receive best supportive care, which includes treatments like radiation, steroids, pain medication, and other palliative procedures, at the physicians discretion. Treatment continues until disease progression, intolerable side effects, withdrawal, death, or end of study. During the study, participants will have regular assessments to monitor overall survival and other outcomes such as progression-free survival, symptomatic progression, skeletal-related events, and time to pain or fatigue worsening. Laboratory tests and monitoring for adverse events will occur up to 2 years and 8 months. Participants will receive ongoing evaluation to track treatment effects and safety throughout the trial duration, which spans until August 2028.

Researchers are evaluating selinexor, a drug, in people with myelofibrosis MF who have not previously been treated with JAK inhibitors and who have normal or mildly to moderately low platelet counts. The main goal is to see if selinexor can reduce spleen size by at least 35% after 24 weeks. The study also looks at other measures of effectiveness and safety during the treatment period. Participants receive oral selinexor tablets once weekly, either 60 mg or 40 mg, taken on days 1, 8, 15, and 22 of each 28-day cycle. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. Based on how the spleen responds at weeks 12 or 24, additional medications may be added to the treatment plan. During the study, participants will provide bone marrow biopsy samples and complete daily symptom assessments using a special questionnaire. Researchers will monitor spleen volume, symptom changes, and any side effects from the treatment. The study is planned to last up to about 48 months, allowing for long-term safety and effectiveness evaluation.

This research aims to evaluate the efficacy and safety of belantamab mafodotin given with standard cancer treatments in adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or is not responding to prior treatments. The study focuses on whether giving belantamab mafodotin less frequently can still control the cancer while reducing side effects, especially those affecting the eyes. It is a phase 2, open-label study sponsored by GlaxoSmithKline. Participants will receive belantamab mafodotin combined with one of three standard treatment regimens pomalidomide and dexamethasone bortezomib and dexamethasone or carfilzomib and dexamethasone. The study uses an extended dosing schedule to assess if less frequent dosing maintains effectiveness. The treatment continues as per the assigned combination, with no randomization, in multiple centers. During the study, participants will be regularly assessed for response to treatment, including overall response rate and complete response rate, up to about 52 months. Safety will be monitored by recording side effects and eye health through ophthalmic exams. Participants will undergo laboratory tests and clinical evaluations throughout the study. The research will also track how well patient-reported eye symptoms match clinical findings, with the total study duration extending up to approximately four years.

This multinational Phase 4 study evaluates the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling in people aged 40 to 85 years with Chronic Obstructive Pulmonary Disease COPD. The study focuses on changes in mucus plugging and how these relate to lung function, exacerbations, and quality of life. Participants receive either dupilumab or placebo via subcutaneous injection according to the study protocol. Treatment lasts up to 24 weeks, and the total study duration can be up to 40 weeks. There are two treatment groups in a randomized, double-blind, placebo-controlled, parallel design. During the study, participants attend nine visits for assessments including lung imaging to measure mucus volume and airway wall thickness, lung function tests using forced oscillation technique, and monitoring for adverse events. The main outcome is the change in global lung mucus score from baseline to Week 24. Safety is followed through Week 36, with ongoing evaluation of lung inflammation and resistance.

Researchers are investigating how exercise might affect treatment outcomes for patients with metastatic colorectal cancer receiving chemotherapy. The study focuses on whether exercise can prevent changes to chemotherapy doses caused by toxicity, improve immune function, and enhance progression-free survival. It also seeks to identify the best type and amount of exercise for these benefits. This is a randomized, multi-arm trial using a Bayesian adaptive design to efficiently compare different exercise programs while minimizing patient exposure to less effective options. Participants are randomly assigned to one of three groups a resistance and continuous aerobic exercise group, an aerobic interval and continuous aerobic exercise group, or a usual care group. Those in the exercise groups engage in supervised moderate-to-high intensity sessions twice a week, plus a third session at home. The exercise includes activities like walking, cycling, and resistance exercises targeting large muscle groups. The usual care group receives standard treatment with exercise guidelines provided. The study uses several interim analyses to potentially stop less effective exercise arms early. During the study, participants undergo regular assessments including chemotherapy dose modifications, progression-free survival, immune cell function, hospitalization, treatment-related toxicities, fitness, muscle strength and mass, quality of life, fatigue, resilience, empowerment, and physical activity levels. These measures are taken from baseline through multiple chemotherapy cycles over several months, with outcomes monitored for up to two years. The study aims to better understand how exercise affects treatment effectiveness and patient well-being in metastatic colorectal cancer.

Researchers are evaluating the combination of JSB462 luxdegalutamide with abiraterone compared to an androgen receptor pathway inhibitor ARPI, which includes abiraterone or enzalutamide, in adult males with metastatic hormone-sensitive prostate cancer mHSPC. This Phase II study aims to assess the effectiveness and safety of two doses of JSB462 100 mg and 300 mg daily combined with abiraterone and to select the recommended dose for future Phase III trials. The study will analyze overall treatment response, safety, tolerability, and pharmacokinetics. Participants will undergo a screening period of 28 days before starting treatment. During treatment, they will receive daily oral doses of JSB462 at either 100 mg or 300 mg combined with abiraterone 1000 mg, or they will receive abiraterone 1000 mg or enzalutamide 160 mg alone. Treatment continues until disease progression, unacceptable side effects, death, or decision by the participant or investigator. After treatment ends, there is a 30-day safety follow-up visit, followed by a long-term follow-up period to collect ongoing safety, efficacy, and survival information until the study concludes. Throughout the study, participants will have regular assessments including prostate-specific antigen PSA levels, imaging scans, adverse event monitoring, dose adjustments, and pharmacokinetic sampling. Patient-reported outcomes and various survival and response rates will be evaluated up to approximately 83 months. Safety follow-up visits occur about 30 days after treatment stops, and long-term monitoring continues until the studys end, ensuring comprehensive data collection on treatment effects and participant well-being.