Levallois Perret

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

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.

Researchers are evaluating the safety and effects of Abrocitinib in adults with moderate to severe atopic dermatitis, a long-lasting skin condition that causes inflammation, redness, and irritation. This observational study aims to understand how Abrocitinib works in real-life clinical settings for patients aged 18 and older who do not have other medical conditions that would prevent them from taking the medication. All participants will take Abrocitinib as a daily tablet and may also use medicated topical treatments for their condition. The study lasts 24 months, during which participants will be monitored regularly. They will visit the study clinic approximately five times, about once every 4 to 6 months, to report their experiences and health status while using the medication. Throughout the study, researchers will assess participants using various measures such as skin condition scores, itching severity scales, and sleep quality assessments. They will also track treatment adherence, any changes in medication dosage, and any side effects. The main outcome focuses on the proportion of patients achieving clear or almost clear skin after 16 weeks, with ongoing evaluations through 24 months to monitor safety and effectiveness.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

This research aims to evaluate the feasibility of combining radiotherapy, chemotherapy docetaxel, cisplatin, and 5-fluorouracil, and spartalizumab an anti-PD-1 therapy in patients with metastatic squamous cell carcinoma of the anus SCCA. Patients with metastatic or recurrent SCCA often receive systemic chemotherapy, and recent studies have shown that taxane-based regimens like modified DCF mDCF can be effective. This study explores adding immunotherapy and radiotherapy to improve treatment outcomes and understand resistance mechanisms. The treatment involves multiple phases. Phase 1 includes delivering 8 Gy radiotherapy to target lesions. Phase 2 consists of combined mDCF chemotherapy every two weeks for 8 cycles alongside spartalizumab given intravenously every 4 weeks. Phase 3 addresses residual disease through multimodal treatments such as surgery, hypofractionated radiotherapy, or radiofrequency ablation, plus chemo-radiotherapy for local disease if there is no progression. Phase 4 provides maintenance treatment with spartalizumab every 4 weeks for up to 12 months from enrollment. Participants will undergo various assessments including CT and PET scans, blood sample collection for immune monitoring and circulating tumor DNA analysis at multiple time points, and regular clinical evaluations. Researchers will measure progression-free survival at 1 year as the primary outcome, along with response rates and overall survival over about 3 years. Safety monitoring and biomarker studies will help understand the potential combined effects of chemotherapy, immunotherapy, and radiotherapy in this patient group.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

The TEMPOS-GEniToUrinary Group GETUG study is a multicenter, medico-economic trial comparing two radiation treatmentsbrachytherapy and stereotactic body radiotherapy SBRTin men with low and intermediate risk prostate cancer. The study particularly focuses on erectile dysfunction as a key outcome. Researchers aim to evaluate the cost-utility of SBRT compared to standard Iodine 125 brachytherapy over a period of three years after treatment, including secondary analyses on cost-effectiveness and quality of life up to five years. Participants are assigned to one of two treatment groups. The experimental group receives SBRT delivering 7.25 Gy per fraction, given in five doses for a total of 36.25 Gy to the prostate. Fiducials are implanted in the prostate to help guide treatment using Cyberknife or a conventional linear accelerator with tracking systems. The control group receives brachytherapy with Iodine 125, delivering a total dose of 144 Gy to the prostate. The study includes long-term follow-up to assess erectile dysfunction, genito-urinary and gastro-intestinal toxicities, and quality of life up to five years after treatment. Participants will undergo monitoring and assessments throughout the study period, including evaluations of erectile dysfunction and other side effects. The main outcome measured is the incremental cost-utility ratio comparing SBRT to brachytherapy at three years, with further health economic evaluations at five years. The trial plans to recruit about 240 men across multiple centers over two years, with ongoing data collection on treatment impact, side effects, and quality of life to inform future treatment recommendations and health insurance budgeting.

Researchers are evaluating the medical benefit of spa therapy on skin and soft tissue fibrosis that occurs as a late reaction at least 6 months after radiotherapy for breast cancer or Upper Aerodigestive Tract UADT cancer. This randomized, controlled, multicenter trial aims to assess improvements in quality of life related to dermatological sequelae of fibrosis. The study focuses on patients with severe late reactions and compares immediate versus delayed spa treatment. The intervention being studied is a dermatologically oriented thermal cure that includes sedative and muscle-relaxing baths, decongestant sprays, and high-pressure thread-like showers using thermal water. Educational workshops on relaxation, sophrology, and hygiene are also part of the therapy. Participants are randomly assigned to receive spa treatment either immediately within 6 weeks of inclusion or after a 6-month delay, allowing comparison of outcomes between early and late treatment groups. Participants will be involved for at least 6 months, during which they will self-assess their dermatological quality of life using the DLQI score and undergo evaluations of generic and cancer-specific quality of life. Additional assessments include self-reported sequelae, radiological examinations of lesions, thickness, and volume, as well as monitoring of treatment and medical consultations. Adverse events and long-term quality of life benefits up to 12 months will be recorded to understand the therapys impact and safety.

Malodorous wounds, which can be necrotic, infected, malignant, or complicated by fistulas or abscesses, often produce unpleasant smells due to bacteria releasing volatile organic compounds. These odors can cause social and psychological discomfort such as shame and isolation. This research aims to evaluate a new cinnamon-containing anti-odor dressing compared to a standard charcoal dressing in improving quality of life, discomfort, and appetite in patients with these wounds. Participants will be randomly assigned to use either the cinnamon dressing or the charcoal dressing as a secondary, non-occlusive dressing over their primary wound dressing. The cinnamon dressing contains cinnamon powder to adsorb and modify odors, while the charcoal dressing adsorbs volatile compounds. Dressings will be changed once daily for 14 days, and assessments will be made at several timepoints including day 0, 1, 3, 7, and 14. During the study, participants will report on wound-related odor discomfort, quality of life using the Wound-Qol questionnaire, and appetite via the SEFI scale. Caregivers and family members will also evaluate odor discomfort. The study will monitor dressing usability, any reactions or discomfort, and overall improvements in symptoms. Participation will last for 14 days with evaluations at specified intervals to assess the impact of each dressing on patients well-being.

This research aims to compare the safety and effectiveness of the Genefill Contour4 hyaluronic acid device with another marketed hyaluronic acid device, Desirial Plus, for labia majora augmentation in women experiencing labia majora hypotrophy or atrophy. The study focuses primarily on assessing the safety of Genefill Contour4 and also evaluates patient symptoms, satisfaction, sexual function, and pain during injection. An additional study within this trial will measure changes in labia volume and distance after treatment. Participants will be randomly assigned to receive injections of either Genefill Contour4 or the comparator Desirial Plus. Injections are given at the first visit, with an optional touch-up at week 4 if needed. The trial lasts for 12 months and involves a total of 8 visits, including screening, five in-person visits, and two phone calls. Both devices are administered similarly, and the study is single-blinded. During the study, participants will be closely monitored through multiple assessments, including the Global Aesthetic Improvement Scale evaluated by both investigators and participants at weeks 4, 12, 24, and 52. Sexual function and patient satisfaction are tracked periodically, along with pain during injections and overall adverse events. The main safety measure is the number of adverse device effects within the first 8 weeks after injection. This comprehensive monitoring continues throughout the 12-month study period to gather detailed safety and effectiveness data.