Manresa

Researchers are evaluating treatment options for patients with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary who have no remaining tumor after primary tumor debulking surgery. This phase II, multicenter, randomized, open-label study aims to compare the recurrence-free survival between patients receiving 3 cycles versus 6 cycles of carboplatin plus paclitaxel chemotherapy, followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two treatment groups one group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib maintenance therapy starts at a dose of 200 mg or 300 mg once daily and continues until disease progression, unacceptable side effects, or other stopping criteria. Tumor assessments using CT or MRI scans are done at specific intervals, and the tumor marker CA-125 is measured every 12 weeks. Clinical visits for blood tests and toxicity monitoring occur regularly during chemotherapy and niraparib maintenance. During the study, participants will attend clinical visits for safety monitoring, including adverse event tracking, blood counts, physical exams every 12 weeks, and serum pregnancy tests for women of childbearing potential. Tumor evaluations occur 9 to 12 weeks after starting therapy and then every 6 months. The study will follow patients for up to 8 years to measure recurrence-free survival and other outcomes such as overall survival, quality of life, and safety. About 640 patients will be recruited across approximately 60 sites in six European countries over 36 months.

Researchers are conducting a prospective, multicenter observational study to create a registry for patients with unresectable locally advanced or metastatic breast cancer. This study includes patients diagnosed from January 2016 onwards, either at first diagnosis or after recurrence. Treatment choices are made independently by physicians, and the study does not specify any treatment regimen. The study groups are defined by breast cancer subtypes based on receptor expression, including Luminal A-like, Luminal B-like HER2 negative and positive, HER2-enriched, and Triple Negative subtypes. Since this is an observational study, patients receive standard care as determined by their doctors, and no intervention is assigned by the study. Participants medical records and disease management data will be collected and reviewed over an 8-year period. Researchers will evaluate the distribution of breast cancer subtypes, patient and tumor characteristics, hereditary risk factors, gender differences in disease progression, timing of primary tumor surgery, and biomarker presence in tumor and blood samples. Patients may withdraw consent at any time, and the study aims to follow patients until death or study completion.

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 novel combination treatment options for adults with locally advanced or metastatic Non-Small Cell Lung Cancer NSCLC in this Phase II, multi-center, open-label study. The trial includes several sub-studies focused on specific NSCLC populations based on genomic alterations and PD-L1 expression levels. The study aims to assess the safety, tolerability, and preliminary antitumor activity of various drug combinations across approximately 80 centers worldwide. Participants will receive one of three investigational drug combinations administered by intravenous infusion rilvegostomig with or without ramucirumab for first-line NSCLC with non-actionable genomic alterations and varying PD-L1 expression levels, or Dato-DXd combined with ramucirumab with or without rilvegostomig for later-line NSCLC with actionable genomic alterations. Treatments continue until disease progression, unacceptable side effects, or withdrawal from the study. Each sub-study may include initial safety run-in cohorts followed by dose expansion cohorts. Throughout the study, participants will undergo regular evaluations including tumor imaging to assess response, clinical safety monitoring, and laboratory testing. Researchers will measure outcomes such as adverse events, objective response rates, progression-free survival, and overall survival over an average of three years. Pharmacokinetics and immunogenicity of the study drugs will also be monitored. Participation involves ongoing treatment and follow-up visits until study completion or discontinuation.

Researchers are studying the combination of YL201 and atezolizumab in adults with extensive-stage small cell lung cancer ES-SCLC and other advanced solid tumors. This phase IbII, multicenter, open-label trial has two parts the first part focuses on dose escalation to assess safety and tolerability, while the second part includes dose optimization with randomization and dose expansion based on safety and efficacy data. The study aims to find the best dose of YL201 combined with a fixed dose of atezolizumab. Participants receive YL201 through intravenous infusion on Day 1 of each 21-day cycle at one of three dose levels 1.2 mgkg, 1.6 mgkg, or 2.0 mgkg combined with 1200 mg of atezolizumab given intravenously on the same schedule. The studys dose optimization stage randomly assigns participants to one of the YL201 dose groups, and treatment continues until disease progression, unacceptable side effects, or withdrawal of consent. Dose expansion will follow, selecting one or two doses based on earlier findings. During the study, participants undergo monitoring for safety, including dose-limiting toxicities over 21 days and adverse events throughout treatment or until death up to about 6 years. Researchers will also assess tumor response, duration of response, progression-free survival, overall survival, and drug pharmacokinetics for up to 3 years. The total study duration extends until February 2029, with regular evaluations to track treatment effects and participant health.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are evaluating how well intranasal esketamine works alongside standard care to quickly reduce symptoms of major depressive disorder MDD in adolescents aged 12 to 17 who experience acute suicidal thoughts or behaviors. This Phase 3 study compares esketamine plus standard care with a psychoactive placebo plus standard care to assess symptom improvement in this vulnerable population. Participants receive either intranasal esketamine 84 mg twice weekly for 4 weeks with a possible dose reduction to 56 mg, or oral midazolam plus intranasal placebo with similar dosing schedules. The treatment period includes dosing on Days 1, 4, 8, 11, 15, 18, 22, and 25, with dose flexibility based on investigator judgment. This double-blind, randomized trial involves two groups receiving either the experimental or placebo regimen. During the study, participants are monitored through clinical assessments including the Childrens Depression Rating Scale - Revised CDRS-R at baseline and 24 hours after the first dose, among other measures of depressive symptoms and suicidality throughout the 25-day treatment. Safety is assessed via medical exams, vital signs, and ECG. The primary outcome focuses on depressive symptom changes within 24 hours, with secondary outcomes tracking symptom progression, remission, and suicidality severity during treatment.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.