La Roche Sur Yon

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are studying metastatic renal cell carcinoma (RCC), a type of kidney cancer that spreads to other parts of the body, affecting many patients annually in France. This study focuses on patients with oligoprogressive disease, where only a few metastatic sites (1 to 3) show progression while the rest remain controlled under ongoing systemic treatments like targeted therapies or immunotherapy. The goal is to evaluate stereotactic radiotherapy (SRT) as a focused treatment to control these progressing sites and potentially delay the need for changing systemic therapies. The study involves delivering stereotactic radiotherapy, which uses high doses of radiation in one or a few sessions to target metastatic sites specifically. Patients with up to three progressive metastases eligible for SRT will receive this treatment concurrently or sequentially alongside their current systemic therapy. This approach aims to control tumor growth locally and possibly stimulate a broader immune response. The trial is a Phase II study, assessing this treatment strategy in patients receiving first or second-line systemic therapies. Participants will undergo imaging scans to confirm disease progression and lesion sizes, with follow-up assessments to monitor progression-free survival six months after randomization. Researchers will evaluate how well the targeted radiotherapy controls tumor sites and delays further disease progression. Patients will be closely monitored for treatment effects, ability to continue systemic therapy, and overall safety throughout the study period.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are studying patients with completely removed non-small cell lung cancer (NSCLC) who have common EGFR mutations (L858R and Del19). The study aims to include broad-panel centralized genetic testing at the start to better understand factors predicting outcomes and resistance to the drug osimertinib when used after surgery. It also investigates the molecular changes linked to cancer returning during or after osimertinib treatment to find better treatment options if the cancer comes back in a metastatic form. The study involves collecting plasma circulating tumor DNA (ctDNA) samples before surgery (optional), 4 to 8 weeks after surgery, before starting any adjuvant chemotherapy or osimertinib treatment, every six months during follow-up, and at relapse. Tumor tissue samples from surgery and optionally at relapse are also collected for molecular analysis. Patients may receive adjuvant chemotherapy if needed before starting osimertinib, which is given with the intent to treat for three years. Participants will be regularly followed every 3 to 6 months according to standard recommendations. Researchers will monitor genetic markers using blood and tissue samples to study cancer relapse and resistance. The main outcome is to assess the feasibility of this molecular monitoring approach over an 18-month period. Safety and long-term follow-up are included, aiming to improve treatment decisions for patients with resected NSCLC and EGFR mutations.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the safety and effectiveness of Dato-DXd in patients with metastatic hormone receptor-positive, HER2 IHC 0 breast cancer that cannot be treated with chemotherapy. This Phase IIIb, multinational, open-label study focuses on patients whose cancer is locally advanced, inoperable, or metastatic and has not responded to endocrine therapy. About 100 participants will receive Dato-DXd at a dose of 6 mg/kg by intravenous infusion every 3 weeks, up to a maximum dose of 540 mg for those weighing 90 kg or more. Treatment will continue until the cancer progresses as assessed by imaging criteria (RECIST 1.1), unacceptable side effects occur, or the participant chooses to stop. Tumor biopsies and blood samples will be collected at baseline, during treatment, and at progression to study biomarkers. Tumor imaging will be done every 8 weeks for the first 48 weeks, then every 12 weeks thereafter until disease progression or new anticancer therapy starts. Participants will undergo regular evaluations including tumor imaging, laboratory tests, and biomarker analyses. The main outcome measured is progression-free survival, defined as the time from the first dose until cancer progression or death, assessed up to about 24 months. Safety and tolerability will be closely monitored throughout the study, which is expected to enroll over 18 months with data cutoff about 6 months after the last participant is dosed.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.