Saint Mande

Researchers are evaluating how well a special imaging scan called 68Ga-FAPI-46 PETCT can predict the response of early-stage high-risk triple-negative breast cancer TNBC to treatment before starting therapy. This study focuses on patients receiving a combination of pembrolizumab, a type of immunotherapy, with chemotherapy as a standard care approach. The study is prospective and involves multiple centers collaborating to understand treatment outcomes better. Patients will receive pembrolizumab at a dose of 200 mg every three weeks alongside 4 cycles of paclitaxel plus carboplatin chemotherapy, followed by 4 cycles of either doxorubicin or epirubicin plus cyclophosphamide. After surgery to remove the tumor, participants will continue with up to 9 cycles of pembrolizumab as adjuvant therapy or until cancer returns or unacceptable side effects occur. Before treatment begins, each patient will have a 68Ga-FAPI-46 PETCT scan performed within 14 days, using the same machine as the standard 18F-FDG PETCT scan. During the study, researchers will collect imaging data and monitor patients throughout the entire treatment and follow-up period. They will assess how well the imaging scan predicts the tumors histological response to therapy by measuring outcomes such as the area under the ROC curve at 6 months. The study will also compare the predictive and prognostic performance of the 68Ga-FAPI-46 PETCT scan against the standard 18F-FDG PETCT scan. Participants will be followed closely for safety and treatment response during the neoadjuvant, surgical, and adjuvant phases of care, with the study ending by November 2032.

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 studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

This trial enrolls participants from previous studies evaluating adagrasib either alone or combined with other cancer therapies in patients with non-small cell lung cancer, colorectal cancer, and other advanced solid tumors. It is an open-label continuation study designed to provide long-term treatment for cancer patients who have already participated in those parent trials. The study is sponsored by Mirati Therapeutics Inc. and focuses on treatment of solid tumors. Participants receive adagrasib and may also receive other cancer drugs such as pembrolizumab, cetuximab, pemetrexed, docetaxel, irinotecan, leucovorin, oxaliplatin, and fluorouracil. The dosing and schedule are specified but depend on the parent study protocols. This trial includes multiple experimental arms reflecting different treatment combinations or regimens, continuing treatment for eligible patients who showed clinical benefit in the parent studies. During the study, participants are monitored for adverse events up to 90 days after their last dose or if they discontinue treatment. Researchers track serious adverse events, treatment-related discontinuations, and deaths related to adverse events. Participation involves ongoing treatment and safety assessments, with the study lasting until the primary completion date in February 2028. The study does not include healthy volunteers and involves adults aged 18 years and older.

Researchers are studying repotrectinib TPX-0005 in adults and adolescents with advanced solid tumors that have specific gene rearrangements in ALK, ROS1, or NTRK1-3. The trial aims to find the safest and most effective dose in Phase 1, and then evaluate how well the drug works in Phase 2 across different patient groups with these gene changes. This includes patients with tumors that have spread and those with brain involvement, focusing on response rates and survival outcomes. The study involves oral doses of repotrectinib. Phase 1 includes dose escalation to determine dose-limiting toxicities, maximum tolerated dose, and recommended dose for Phase 2. A sub-study also examines drug interactions with midazolam. In Phase 2, participants are assigned to one of six groups based on their tumor type and prior treatments, including different lines of targeted therapy and chemotherapy. Treatments continue according to protocol with regular monitoring. Participants will have measurable tumors confirmed by imaging reviewed centrally. They undergo physical exams, lab tests, and safety assessments throughout the study. Researchers measure response rates, duration of response, progression-free survival, overall survival, and clinical benefit over several years. The study monitors drug levels in blood and evaluates safety closely. Participation may last years with follow-up to assess long-term outcomes and effects on brain metastases.

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.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Researchers are investigating treatments for metastatic clear cell renal cell carcinoma RCC, a type of kidney cancer. The study compares two combination therapies one using two immune checkpoint inhibitors ICI-ICI and the other combining an immune checkpoint inhibitor with a vascular endothelial growth factor receptor tyrosine kinase inhibitor ICI-VEGFR TKI. The goal is to determine which approach better improves overall survival and progression-free survival based on PD-L1 biomarker status, addressing the current lack of direct comparison between these treatments. Participants will receive one of two treatment plans. One group will get nivolumab and ipilimumab infusions every three weeks, followed by maintenance nivolumab for up to two years. The other group receives an investigators choice among three combinations axitinib plus pembrolizumab, cabozantinib plus nivolumab, or lenvatinib plus pembrolizumab. Oral and intravenous medications are administered at specified doses and schedules, with treatment continued until progression, unacceptable side effects, or two years of therapy. During the study, participants will undergo evaluations including survival tracking, tumor response assessments, and quality of life questionnaires at regular intervals. Researchers will also monitor treatment duration, adverse events, health economics, and collect biological samples for future research. The study plans to enroll 1,250 patients over four years across multiple European countries, with a total follow-up period extending up to 97 months to assess long-term outcomes.

Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment improves overall survival in patients with metastatic urothelial bladder cancer. This study focuses on patients who have no disease progression and have no more than three remaining distant metastatic lesions after completing first-line systemic therapy. It is a Phase II, randomized, open-label study conducted at multiple centers. Participants will be randomly assigned either to receive standard care alone or to receive consolidative radiotherapy targeting the pelvis andor metastatic sites in addition to standard care. Some patients may have had a previous bladder tumor resection. The radiotherapy is given after the initial systemic treatment phase, which includes chemotherapy andor immunotherapy. The study follows patients for four years from the time of randomization. During the study, patients will have regular assessments including imaging scans to check disease status, toxicity evaluations according to national criteria, and quality of life questionnaires using the EORTC QLQ-C-30 tool. Researchers will monitor overall survival and progression-free survival over four years. Patients must be able to participate and agree to follow the study procedures, and safety is closely observed throughout the trial.