Montpellier

Researchers are evaluating litifilimab BIIB059, a monoclonal antibody, in adults with active cutaneous lupus erythematosus CLE. This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus SLE, who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after previous therapy. This study compares the effects of two oral drug combinations belzutifan plus zanzalintinib versus cabozantinib. The aim is to find out if the combination of belzutifan and zanzalintinib helps patients live longer overall and delays cancer progression compared to cabozantinib alone. Participants in this study will be randomly assigned to one of two groups. One group will take belzutifan and zanzalintinib orally once daily, while the other group will take cabozantinib orally once daily. Treatment will continue until certain conditions require stopping. This is an open-label, phase 3 trial evaluating these treatments in people with advanced RCC who have had disease recurrence during or after prior anti-PD-1L1 therapy. During the study, participants will be monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also track response rates, duration of response, side effects, and quality of life using questionnaires over about 25 months. Safety assessments and regular evaluations will be performed as part of the study. Total study participation may last several years, depending on individual circumstances and treatment continuation.

Researchers are investigating new treatments for high-risk, early-stage breast cancers that are either triple-negative or hormone receptor-low positive and HER2-negative. These types of breast cancer have limited amounts of certain proteins that affect growth, making them challenging to treat. This Phase 3 trial aims to compare the effects of adding sacituzumab tirumotecan, a targeted therapy, to pembrolizumab and chemotherapy against pembrolizumab with chemotherapy alone in controlling cancer growth and spread. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab tirumotecan intravenously every two weeks along with pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab combined with carboplatin and paclitaxel for another 12 weeks. After this, surgery and optional radiation therapy occur, followed by pembrolizumab infusions for up to about 28 weeks. Additional treatments such as olaparib, capecitabine, or doxorubicin with cyclophosphamide may be given if cancer remains. The other group receives chemotherapy drugs carboplatin, paclitaxel, cyclophosphamide, and doxorubicin or epirubicin alongside pembrolizumab during similar time frames, followed by surgery, radiation, and pembrolizumab maintenance with possible additional treatments. Throughout the study, participants undergo assessments including surgery to remove tumors, imaging, and laboratory tests. Researchers measure cancer cell presence after surgery and monitor how long participants live without cancer progression or recurrence, as well as overall survival. Quality of life and side effects are tracked using questionnaires over several years. Safety is monitored by recording adverse events and treatment discontinuations. The study may last up to around 115 months for long-term follow-up.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a serious autoimmune condition. This Phase 2 study compares ianalumab against a placebo to better understand its effects on this disease. The study is sponsored by Novartis Pharmaceuticals and aims to assess how ianalumab impacts disease activity and progression. The study includes multiple periods a screening period lasting up to 6 weeks a first treatment period of 52 weeks where participants receive either ianalumab or placebo injections followed by a second open-label treatment period of an additional 52 weeks where all participants receive ianalumab. After treatment, there is a post-treatment follow-up period lasting at least 20 weeks and up to 2 years to monitor long-term effects. Participants will undergo regular assessments including measuring their response using the 35 rCRISS25 scale at Week 52, lung function changes, skin thickness scores, and physical disability indexes. Blood samples will be collected throughout the study to monitor drug levels and antibodies. Safety is closely monitored by recording any adverse events during the entire study duration, which can last up to 208 weeks. The study involves detailed clinical evaluations and laboratory tests to fully assess the impact of ianalumab on this condition.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 years who have early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia. The study is a phase III trial designed to compare trontinemab with a placebo to better understand its impact on cognitive decline in Alzheimers patients. Participants will be randomly assigned to receive either intravenous IV trontinemab or an IV placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Treatment and monitoring will continue for 72 weeks, during which various cognitive and biological measures will be assessed. Throughout the study, participants will undergo regular assessments including cognitive tests like the Clinical Dementia Rating, Sum of Boxes CDR-SB, and the Mini-Mental State Examination MMSE. Brain imaging scans such as amyloid and tau PET scans, as well as MRI, will be used to observe changes in brain pathology. Researchers will also monitor safety by tracking adverse events, infusion reactions, and the presence of antibodies against trontinemab. Participants will be supported by a study partner and will be closely followed during the entire study period.

Researchers are developing a prospective clinico-biological database focused on cachexia and undernutrition in patients with colon cancer. Cachexia is a serious syndrome marked by rapid, involuntary weight loss affecting fat and muscle tissues, which can contribute to treatment failure and increased mortality. This study aims to improve understanding of cachexia to enhance patient care and survival by integrating nutritional approaches and clinical nutrition advancements. Participants will have blood samples collected at the start of the study and every six months during treatment, alongside standardized clinical data entered into a database. This collection supports future research projects aimed at tailoring management strategies for patients with colon cancer-related cachexia. The study involves patients treated at a regional cancer institute and monitors biological and clinical risk factors over six years. During the study, participants will undergo regular clinical assessments and blood sample collections to track nutritional and metabolic changes. Researchers will measure the number of clinical and biological risk factors for colorectal cancer until the studys completion. This ongoing monitoring will help identify factors influencing treatment response and toxicity. Participation continues for up to six years, allowing long-term data collection and follow-up.

Digestive cancers, including colorectal cancer, are a major health concern worldwide, accounting for 30 of all cancers. This research aims to create a collection of blood samples from patients with metastatic digestive adenocarcinoma who are receiving first or second line treatments. The goal is to study blood biomarkers that could help tailor treatments by predicting and monitoring response in a minimally invasive way. Patients in the study will have blood samples collected before starting treatment and then approximately every two months during treatment until it ends. Alongside this biological collection, standardized clinical data will be recorded in a database. This approach focuses on blood rather than tumor tissue, allowing repeated sampling to better understand tumor dynamics and treatment effects. Participants will be involved throughout their treatment period with regular blood draws and clinical data collection. Researchers will measure clinical and biological risk factors related to metastatic digestive cancer over a study period of up to 54 months. This ongoing monitoring aims to support research projects that improve personalized patient management strategies. The study is sponsored by the Institut du Cancer de Montpellier - Val dAurelle.

Researchers are evaluating BGB-16673, an orally administered Bruton Tyrosine Kinase targeted protein degrader, in adults with various B-cell malignancies including relapsed or refractory forms of marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemiasmall lymphocytic lymphoma, Waldenstrf6m macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. The study aims to find the recommended dose and assess the safety, tolerability, and response rates in this population through a phase 12 open-label trial. The trial includes several parts a phase 1 monotherapy dose finding with dose escalation and safety expansion, followed by phase 2 expansion cohorts. Participants receive BGB-16673 orally at various dose levels to determine the maximum tolerated dose and the recommended dose for further study. Specific groups include Japanese participants and those who have not previously received a Bruton Tyrosine Kinase inhibitor. Dose escalation and safety data are collected to guide dosing recommendations, with some cohorts focused on particular lymphoma subtypes and treatment histories. Participants will be monitored from the first dose of BGB-16673 until 30 days after the last dose or before starting new anticancer therapies, for up to 47 weeks in phase 1 and approximately three years in phase 2. Assessments include adverse event tracking, response rates, pharmacokinetics, and quality of life questionnaires. Various measures such as plasma drug concentration, protein degradation, and progression-free survival are evaluated periodically. Safety and efficacy data support long-term monitoring and dose adjustments throughout the study period.

Researchers are studying the safety and appropriate dosing of OT-C001, a type of amplified and activated allogenic natural killer cells, in patients with relapsed or refractory diffuse large B-cell lymphoma who have limited treatment options. This early-phase clinical trial also aims to observe the preliminary activity of OT-C001 in fighting this form of lymphoma. The study is led by Emercell SAS and focuses on patients with evaluable disease and adequate biological conditions. Participants will first receive a short course of chemotherapy before starting OT-C001 treatment. During the treatment phase, they will receive weekly intravenous infusions of OT-C001 for either 3 or 6 weeks, depending on their assigned dose group. Additionally, participants will be given two supporting drugs, rituximab and interleukin-2, as part of the treatment plan. There are different dosing levels being tested, including one vial, three vials, or a sub-dose of OT-C001. Throughout the study, participants will visit the clinic regularly and may need hospitalization based on the study plan. Researchers will monitor safety by assessing adverse events, lab tests, vital signs, ECGs, and physical exams from the start of treatment until shortly after the last dose. They will also evaluate antitumor activity using imaging criteria at the end of treatment cycles and follow participants every 12 weeks for up to two years to track disease progression or new cancer treatments.

Researchers are studying the safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This open-label, long-term extension study builds on previous ALKS 2680 parent studies and aims to understand how well the treatment works over time and how safe it is for participants living with these sleep disorders. Participants will take oral tablets of ALKS 2680 once daily, with doses ranging from 4 mg to 18 mg. The study is non-randomized and includes groups of people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Those joining the study may need to stop other narcolepsy medications before starting ALKS 2680 and continue taking ALKS 2680 throughout the trial. During the study, participants will be monitored for treatment side effects and changes in sleepiness using tests like the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Researchers will track adverse events for up to 100 weeks and evaluate changes in sleep latency and sleepiness over several months. The study supports close safety monitoring and long-term follow-up from the start in early 2025 until mid-2028.