Saint Gregoire

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

Researchers are comparing the length of time participants survive without signs of cancer returning after treatment for high-risk non-muscle-invasive bladder cancer (HR-NMIBC). This Phase 3 study focuses on patients who have received Bacillus Calmette-Guérin (BCG) treatment and have specific FGFR mutations or fusions. The study aims to evaluate and compare disease-free survival between those treated with TAR-210 and those receiving intravesical chemotherapy chosen by the investigator. Participants will receive either TAR-210, a drug administered directly into the bladder, or one of two chemotherapy drugs, Mitomycin C or Gemcitabine, also given intravesically. All visible tumors must be fully removed before randomization. The study includes patients who are either unresponsive to BCG, experienced with BCG, or intolerant to BCG treatment. Participants must not be eligible for or must refuse radical cystectomy surgery. During the study, participants will be monitored for disease-free survival for up to five years. Researchers will perform assessments including urine testing, tumor tissue analysis, and biopsies as needed to confirm eligibility and monitor disease status. Safety, treatment adherence, and patient health status will be regularly evaluated to ensure ongoing suitability for the study.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

The trial investigates spinal conditions such as spinal stenosis and spondylolisthesis, focusing on reducing the need for lumbar fusion surgery. It evaluates the use of endoscopic techniques for decompressing the lumbar spine, aiming to preserve its natural stability and function. This approach is considered a less invasive alternative to traditional surgical methods, with the hypothesis that it can lower the frequency of more extensive spinal fusion procedures. The study centers on endoscopic decompression procedures as a treatment option for patients with specific lumbar spine pathologies. These minimally invasive surgeries are designed to be optimized and cause less tissue damage. Participants are patients who have spinal conditions requiring surgical intervention, including those with complications such as lumbar scoliosis or degenerative spondylolisthesis. The endoscopic approach is assessed as a potentially effective way to avoid lumbar arthrodesis. Participants will be monitored primarily for the need for any additional surgical interventions within one year after treatment. The study involves evaluations using preoperative imaging, such as radiographs and MRI, to classify spinal abnormalities and determine eligibility. Safety and outcomes are tracked over the course of a year to understand the effectiveness of the endoscopic procedures in reducing the requirement for further surgery.

Researchers are evaluating the consistency of the EMOCARE emotional monitoring software compared to commonly used questionnaires in assessing emotional states in patients with mild to moderately severe depressive episodes. The study aims to determine whether EMOCARE provides results that align with tools like PHQ-9, MADRS, GAD-7, BDI-II, and EQ-5D-5L, and to understand patients' experiences using passive monitoring software without active involvement. This prospective, multicenter, single-blind clinical investigation focuses on adults with major depressive disorder. Participants will use the EMOCARE software on their digital devices such as smartphones or computers, with the ability to activate or deactivate it anytime during the 6-week follow-up. The study includes two scheduled visits six weeks apart, during which participants complete various questionnaires and have consultations with the doctor. Additional assessments include self-administered questionnaires at 2 and 4 weeks post-first appointment and a follow-up phone call at 3 weeks to check on participants' wellbeing. Participants are also asked to keep a diary of symptoms, medical consultations, and medication changes. Throughout the study, researchers will monitor changes in EMOCARE scores and PHQ-9 results from baseline to six weeks. Data collection includes clinical screenings, questionnaires, doctor interviews, and symptom diaries. The study focuses on understanding emotional state assessments and patient experiences over the 6-week period, ensuring participant safety and compliance with protocol requirements.

Researchers are evaluating the safety and effectiveness of an investigational drug called ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with PD-L1-positive recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This study includes both Phase 2 and Phase 3 parts. Ficerafusp alfa targets two cancer-related proteins, EGFR and TGF-beta, which play roles in tumor growth and spread. The goal is to find the best dose and then compare treatment outcomes between groups. In Phase 2, participants will be randomly assigned to one of three groups: ficerafusp alfa 1500 mg weekly plus pembrolizumab every three weeks, ficerafusp alfa 750 mg weekly plus pembrolizumab every three weeks, or placebo weekly plus pembrolizumab every three weeks. Phase 3 will randomize participants to the selected ficerafusp alfa dose plus pembrolizumab or placebo plus pembrolizumab. Treatments will continue as scheduled, and safety, tolerability, and treatment responses will be closely monitored throughout. Participants will undergo assessments including scans to measure tumor response using RECIST 1.1 criteria, safety evaluations for side effects, and survival tracking. Safety monitoring includes checking for treatment-related adverse events up to 30 days after treatment ends and serious events up to 90 days afterward. The study will follow participants for approximately one year in Phase 2 and up to three years in Phase 3 to evaluate treatment effectiveness and overall survival.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.