Saint Etienne

Researchers are investigating metastatic colorectal cancer mCRC patients who have a specific genetic change called the BRAFV600E mutation. This rare subtype of mCRC often shows poor response to current treatments and has a generally poor outlook. The study aims to collect detailed clinical data and biological samples to better understand this condition, including how patients respond to treatments and what factors predict their survival. It focuses on real-world treatment outcomes and biological markers that might influence therapy choices and resistance. Participants will provide blood samples at multiple times during their treatment, including before and during the first three treatment cycles, at 3 and 6 months after starting each treatment line, and when disease progression occurs following certain therapies. The study gathers up to 390 mL of blood per participant over time to analyze circulating tumor DNA and immune environment factors. This observational approach will help researchers identify biomarkers related to treatment response and disease progression. During the study, participants clinical progress and survival will be tracked for up to five years. Researchers will review overall survival from diagnosis to death and assess how prognostic markers relate to progression-free survival and response to treatments. The study involves collecting tumor tissue samples and blood tests, along with routine follow-up visits. All data collected will contribute to understanding BRAFV600E mCRC and improving future treatment strategies.

Malignant hypertension is a very serious form of high blood pressure that can be fatal if untreated. This research aims to create the first large, multicenter database to better understand this disease, including its modern epidemiology, how patients are currently managed, and the diseases diagnostic criteria. The study will help improve knowledge and may lead to new treatment trials and evidence-based recommendations. The study is an observational registry enrolling patients diagnosed with malignant hypertension based on classic definitions, including severe blood pressure elevation and organ damage. It plans to recruit 500 patients and follow them for five years to study their prognosis and the impact of different patient characteristics and organ involvement. By collecting detailed data on disease features and care pathways, the study hopes to update definitions and management approaches. Participants will be observed over five years, with researchers collecting information on their health status, organ damage, and treatment. The main outcome measured is the five-year prognosis of patients. This long-term follow-up will provide detailed knowledge about the disease course and help identify factors influencing outcomes, without any study treatments or interventions being assigned.

Researchers are evaluating the use of stereotactic radiotherapy SRT as a treatment strategy for patients with oligoprogressive metastatic renal cell carcinoma RCC who are already undergoing systemic therapies. This phase II study focuses on patients whose cancer has progressed in a limited number of sites despite ongoing treatment, aiming to control local tumors and delay the need for additional systemic therapies. The study builds on evidence that SRT can effectively target RCC metastases and may also stimulate the immune system when combined with immunotherapy. The study involves delivering high-dose stereotactic radiotherapy to metastatic sites showing progression in patients receiving systemic therapies such as targeted drugs or immunotherapy. Eligible patients have 1 to 3 progressing metastases in up to 2 organs, with lesions measuring 4 cm or less, and will continue their current systemic treatment while receiving SRT either concurrently or sequentially. This approach aims to locally control progressing tumors and potentially extend the effectiveness of ongoing therapy. Participants will undergo imaging assessments to confirm disease progression and measure tumor response, with follow-up visits to monitor tumor control and treatment side effects. Researchers will evaluate progression-free survival six months after randomization as the primary outcome, along with local and overall control rates and treatment-related adverse events. The study includes monitoring for safety and effectiveness up to 12 months post-treatment, with participants involvement lasting until at least one month after treatment completion.

Researchers are evaluating new drugs or combinations of drugs to treat relapsed or refractory peripheral T-cell lymphomas through a platform trial consisting of multiple sub-studies. The study aims to collect exploratory data to better identify patient populations and inform the design of future clinical trials. Phase 1 sub-studies focus on determining safety and tolerability of increasing doses, while phase 2 sub-studies aim to find drugs that significantly improve patient outcomes. The trial includes at least two sub-studies Origina-ly-T, an open-label phase 2 study assessing the efficacy and safety of roginolisib, and GolcAza, an open-label phase 1 study identifying the maximum tolerated dose of golcadomide combined with oral 5-azacitidine. Participants receive the study treatments daily until unacceptable side effects, disease progression, or withdrawal. Origina-ly-T requires 31 patients, and GolcAza requires at least 18 patients. Participants will be monitored through clinical visits and assessments including progression-free survival and dose tolerance over a maximum two-year period. Researchers will evaluate safety, response rates, clinical benefit, time to next treatment or death, overall survival, and transplantation rates following treatment. The study requires adherence to visit schedules and protocol requirements, with careful safety monitoring throughout the treatment and follow-up phases.

Researchers are studying patients with 1p19q-codeleted low-grade oligodendrogliomas who have been treated with radiotherapy plus PCV chemotherapy. The study aims to evaluate whether delaying radiotherapy until tumor progression can reduce the risk of neurocognitive decline without affecting overall survival. This is a phase 3 randomized trial sponsored by Hospices Civils de Lyon, focusing on preserving brain function while managing tumor growth. Participants are randomly assigned to one of two treatment groups one group receives six cycles of PCV chemotherapy alone, and the other group receives radiotherapy followed by six cycles of PCV chemotherapy. Radiotherapy delivers 50.4 Gy in 28 sessions using IMRT technique. PCV chemotherapy includes a cycle with CCNU orally on day 1, vincristine intravenously on days 8 and 29, and procarbazine orally from days 8 to 21. Treatment cycles are repeated six times. During the study, participants will undergo neurocognitive examinations and quality of life assessments. Researchers will monitor survival without neurocognitive deterioration over nine years, along with progression-free survival and overall survival. Laboratory tests and physical evaluations will be conducted before and during the study. The trial includes detailed follow-up to assess the long-term effects of the treatments on cognition and tumor control.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating whether combining vedolizumab and upadacitinib, called dual targeted therapy DTT, reduces bowel inflammation and ulcers more effectively than vedolizumab alone in adults with moderately to severely active Crohns Disease CD. The study also compares the safety and effectiveness of these treatments. This Phase 3b trial is conducted worldwide and sponsored by Takeda, enrolling about 396 participants. Participants are randomly assigned to receive either vedolizumab with upadacitinib or vedolizumab with a placebo for 12 weeks during the Induction Phase. Vedolizumab is given as a 300 mg intravenous infusion at Weeks 0, 2, 6, and 10 upadacitinib or placebo is taken daily by mouth. Those who respond to treatment at Week 12 will continue with vedolizumab alone every 8 weeks for 40 weeks in the Maintenance Phase. Vedolizumab dosing frequency may increase to every 4 weeks if needed. During the approximately 70-week study, participants visit the clinic 15 times for assessments including clinical evaluations, endoscopic exams, and patient-reported outcomes. Researchers measure clinical remission, endoscopic response, and safety outcomes at Week 12 and Week 52. There is also an 18-week safety follow-up after the maintenance period to monitor participants health.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.