Libramont Chevigny

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

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.

This research aims to evaluate the effectiveness of AZD5335 compared to standard treatments in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study focuses on whether AZD5335 improves progression-free survival PFS among participants with either high or low levels of folate receptor alpha FR. Approximately 1100 adult women will be enrolled and divided into two groups based on their FR levels. Participants will be randomized within each group to receive either AZD5335 or the relevant standard treatment. Those with high FR levels will receive AZD5335 or mirvetuximab soravtansine, while those with low FR levels will receive AZD5335 or a chemotherapy agent chosen by the investigator, including paclitaxel, pegylated liposomal doxorubicin, or topotecan. Treatments are given intravenously, and participants will continue treatment until disease progression or other reasons for stopping. During the study, participants will undergo regular tumor assessments to monitor disease status. Researchers will follow all participants over time to evaluate overall survival. Safety and efficacy data will be reviewed periodically by an independent committee. The primary outcome is progression-free survival, measured for up to about five years. The study completion is expected by late 2029.

Researchers are evaluating the best dose of zongertinib, a drug that inhibits HER2, for adults aged 18 years and older with various types of HER2-positive cancers that have spread and cannot be removed by surgery. This study focuses on people whose tumors show HER2 abnormalities and who have not had success with previous treatments. The main goal is to find a dose of zongertinib that patients can tolerate well when combined with other treatments, and to see if zongertinib alone or with these combinations can shrink tumors. Participants receive zongertinib alone or together with other drugs such as trastuzumab deruxtecan, trastuzumab emtansine, trastuzumab with capecitabine, zanidatamab, or mFOLFOX6 with or without trastuzumab. The study has two parts Part 1 involves increasing doses of zongertinib in different groups to find the best tolerated dose. Part 2 randomly assigns participants to different dose groups of zongertinib. Treatment is given in cycles during the study. Throughout the study, participants visit the study site regularly. Doctors monitor tumor size with imaging scans like CT or MRI and check participants health for any side effects. The main measures include identifying dose-limiting toxicities within 21 days and the tumors response over up to 50 months. Safety, drug levels in the body, disease control, progression-free survival, and patient-reported outcomes are also tracked. The study runs until January 2029.

Researchers are evaluating standard neoadjuvant treatment options for patients aged 70 years or older with high-risk stage II and stage III rectal cancer in a multicentre, open-label, randomized clinical trial called SHAPERS. The study compares conventional neoadjuvant therapy with total neoadjuvant therapy TNT to understand their safety and effectiveness for this older patient group. Participants are randomly assigned to one of two groups. The conventional treatment group receives either short course radiotherapy followed by surgery or watch & wait, with optional adjuvant chemotherapy, or long course chemoradiotherapy followed by surgery or watch & wait, also with optional adjuvant chemotherapy. The TNT group receives one of several treatment regimens decided by the investigator before randomization, including combinations of short course radiotherapy, oxaliplatin-based chemotherapy lasting up to 18 weeks, and chemoradiotherapy, followed by surgery or watch & wait. During the study, participants undergo treatments as assigned and are monitored for outcomes including overall survival, progression-free survival, peripheral sensory neuropathy, and severe toxicities over 3 years after randomization. Researchers will gather information about treatment effects, side effects, and patient survival to compare the two approaches. The study includes follow-up assessments to track these outcomes and participant safety throughout the trial duration.

Researchers are evaluating the effectiveness and safety of two combination treatments for adults with hormone receptor positive HR, human epidermal growth factor receptor 2 negative HER2- locally advanced or metastatic breast cancer that has a PIK3CA mutation. These patients have experienced recurrence or progression after treatment with a CDK46 inhibitor. This Phase 3, open-label, randomized study compares RLY-2608 zovegalisib plus fulvestrant against capivasertib plus fulvestrant to determine which treatment better controls the disease. Participants are assigned to one of two groups one group receives zovegalisib orally twice daily along with fulvestrant administered by injection on specific days during a 28-day treatment cycle the other group receives capivasertib orally twice daily on an intermittent weekly schedule plus fulvestrant injections on the same schedule. Treatment cycles repeat every 28 days. The study is conducted globally at multiple centers and continues until disease progression or other criteria are met. During the study, participants undergo regular assessments including scans reviewed by blinded independent central review to measure progression-free survival, as well as monitoring overall survival, response rates, quality of life questionnaires, and safety evaluations. Blood samples are taken periodically to measure drug levels. The study may last up to approximately 77 months for outcome measurements, with ongoing monitoring for adverse events and quality of life changes throughout this period.

Researchers are evaluating the safety and effectiveness of datopotamab deruxtecan Dato-DXd compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer NSCLC that tests positive for trophoblast cell surface protein 2 TROP2 but lacks actionable genomic alterations. This phase III, randomized, open-label study also aims to assess the clinical performance of an investigational diagnostic test related to TROP2 expression. Participants will be randomly assigned to receive either Dato-DXd or docetaxel as an intravenous infusion every three weeks. Each treatment is given on Day 1 of a 21-day cycle. The study includes two groups one receiving Dato-DXd monotherapy and the other receiving docetaxel monotherapy. The study will continue until disease progression or other discontinuation criteria are met. Throughout the study, participants will undergo regular assessments to measure progression-free survival and overall survival over approximately 2.5 to 3.5 years. Additional evaluations include response rates, duration of response, symptom assessments, quality of life questionnaires, and biomarker analyses. Safety monitoring and diagnostic testing will also be conducted. The total participation time will depend on individual treatment duration and follow-up requirements.

Researchers are studying metastatic pancreatic ductal adenocarcinoma PDA in adults who have not been previously treated for this condition. The trial evaluates the effect of adding SBP-101, a small molecule polyamine metabolic inhibitor, to the standard chemotherapy regimen of gemcitabine and nab-paclitaxel. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival and other important outcomes in about 600 patients. Participants will receive either SBP-101 combined with nab-paclitaxel and gemcitabine or a placebo with the same chemotherapy drugs. The treatments are given as injections, and the study includes two groups one experimental arm receiving SBP-101 plus chemotherapy and one control arm receiving placebo plus chemotherapy. The safety and effectiveness of treatments will be monitored throughout the trial by an independent committee. During the study, patients will be followed for overall survival up to 100 weeks or until death. Researchers will also measure progression-free survival, responses seen on scans, and quality of life. Assessments include imaging with CT or MRI, blood tests, and monitoring of side effects. Participants must consent to the study and meet specific health criteria, and safety will be closely observed throughout the trial period.