Olsztyn

Researchers are evaluating remibrutinib (LOU064) in adolescents aged 12 to under 18 years who have chronic spontaneous urticaria (CSU) that is not well controlled by H1-antihistamines. This Phase 3 trial aims to assess the effectiveness, how the drug is processed in the body, and safety of remibrutinib compared to a placebo. The study also intends to gather long-term data on how well remibrutinib works and its safety over several years after treatment ends. The trial includes three periods. First, the core period is a 24-week double-blind phase where about two-thirds of participants receive remibrutinib and one-third receive placebo, with about 10 site visits over approximately 32 weeks. Next is an optional open-label extension lasting from one to three years, where participants who completed the core period may receive remibrutinib or enter an observational treatment-free phase depending on their symptoms. Participants may cycle through treatment and observational periods up to six times. Finally, an optional long-term treatment-free follow-up can last up to three years with one site visit and up to four phone calls. During the study, participants undergo assessments including changes in urticaria activity scores (UAS7), itching severity (ISS7), and hive severity (HSS7) measured from baseline to 12 weeks. Regular visits monitor safety, symptoms, and drug effects. The study tracks these measures to understand remibrutinib's impact on CSU symptoms and overall safety profile during and after treatment, with total participation potentially lasting several years.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the efficacy and safety of UGN-104, a new formulation of UGN-101 (known as JELMYTO), for treating patients with low-grade upper tract urothelial cancer (LG-UTUC). This Phase 3, single-arm, multicenter study focuses on patients with LG-UTUC in the upper urinary tract. The study aims to measure the complete response rate about 3 months after the first treatment instillation. Participants will receive UGN-104 once weekly for 6 weeks, totaling 6 doses. UGN-104 is a drug combining mitomycin with a sterile hydrogel that changes from liquid to gel when warmed, helping deliver the medication directly to the upper urinary tract. Patients who achieve a complete response with no detectable disease at the primary disease evaluation visit may enter a follow-up period, where they can receive monthly maintenance doses of UGN-104 for up to 11 months. Patients will be monitored every 3 months during follow-up for up to 12 months or until disease progression, recurrence, or death. Throughout the study, patients undergo evaluations including urine cytology, visual inspections with ureteroscopy, and biopsies if needed. Response determination is centrally reviewed using laboratory and histopathology assessments. Safety and disease status will be closely monitored during treatment and follow-up visits to assess treatment effect and patient well-being.

Researchers are evaluating the pharmacokinetics and safety of a subcutaneous injection of durvalumab combined with recombinant human hyaluronidase (rHu) in adults with different types of solid tumors. This Phase I multicenter study aims to find a subcutaneous durvalumab dose that provides drug levels similar to intravenous durvalumab. The study includes participants with non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and limited-stage small cell lung cancer (LS-SCLC). The study is divided into two parts: Part 1 involves dose escalation with two planned dose levels of subcutaneous durvalumab in participants with NSCLC, HCC, or LS-SCLC. Part 2 focuses on dose expansion in participants with unresectable HCC, starting once the appropriate dose is identified. Durvalumab plus rHu is given under the skin, while intravenous durvalumab and tremelimumab are administered by infusion for some participants. Participants will be monitored from the first dose through approximately 17 months of durvalumab administration. Researchers will measure drug concentrations over time and the lowest concentration before the next dose. Participants will undergo assessments including safety evaluations, organ function tests, and disease measurements. The study also tracks side effects and overall drug exposure to evaluate safety and pharmacokinetics during treatment.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the safety and effectiveness of various new drug combinations, including novel agents combined with standard treatments, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This open-label, multicenter trial focuses on sub-study 2, which examines rilvegostomig combined with standard platinum-based chemotherapy, with or without ramucirumab, in participants with advanced NSCLC. The study aims to identify optimal doses and expand cohorts to better understand treatment safety and tumor response. The trial involves two parts: Part A includes safety run-in groups to test different dose levels of rilvegostomig and establish the recommended Phase 2 dose if not already known. Part B expands to larger groups to assess treatment effects. Rilvegostomig and other study drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, and ramucirumab are given by intravenous infusion according to the study protocol. Sub-study 1 was canceled and will not take place. Participants will undergo assessments including tumor tissue sampling, disease measurement scans, and laboratory tests to monitor organ function and treatment effects. Researchers will track adverse events, serious adverse events, dose-limiting toxicities, and tumor responses over approximately 46 months. Safety, tolerability, and anti-tumor activity are key outcomes, with follow-up to ensure participant well-being and gather comprehensive data on these novel treatment combinations.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.