Tyler

Researchers are investigating new treatment options for metastatic cervical cancer, a type of cancer that starts in the cervix and has spread to other parts of the body. This study focuses on evaluating sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate designed to target cancer cells, in combination with pembrolizumab and bevacizumab. The main goals are to assess the safety and tolerability of these drugs given together and to see if they help patients live longer or delay cancer progression compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab to assess safety. In Part 2, all participants first receive standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, with optional bevacizumab. Those whose cancer does not worsen then start maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may also be added during maintenance at the doctor's discretion. Treatments are given through intravenous infusions on schedules that range from every 2 to 6 weeks, lasting up to approximately 20 months. During the study, participants will have regular evaluations to monitor safety and how well the treatments work. Assessments include tracking side effects, cancer progression using imaging criteria, overall survival, and quality of life questionnaires focused on health status and physical function. The research team will observe participants for several years to collect data on treatment outcomes and tolerability, with some follow-up lasting up to about 69 months.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL), a fast-growing blood cancer affecting immature B-cells. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles (about 4 months). Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatment's impact.

Researchers are investigating the combination of two investigational drugs, BNT324 and BNT327, in people with advanced or metastatic lung cancer, including both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). This study aims to find safe and effective dose levels, optimize dosing, and evaluate preliminary and clinical efficacy in several lung cancer groups. Participants have advanced or relapsed lung cancer and the trial includes different treatment cohorts based on cancer subtype and previous therapies. The study has two parts: Part 1 tests escalating doses of BNT324 combined with BNT327 to establish two recommended dose levels. In Part 2, participants with specific lung cancer types receive one of these two dose levels to determine the optimal dose. Additional participants may be enrolled to further assess safety and efficacy at this dose. The trial includes both randomized and non-randomized cohorts, with treatments given as intravenous infusions. Participants undergo a screening period before treatment, followed by treatment, safety follow-up, and long-term survival monitoring lasting up to about seven years. Researchers will evaluate safety by tracking side effects and dose modifications, and measure treatment response using objective response rates and other cancer progression markers. Regular assessments include physical exams, imaging, and laboratory tests to monitor health and treatment effects throughout the study.

Researchers are studying TAK-279, an oral medicine aimed at reducing inflammation in adults with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), both serious long-term inflammatory bowel diseases. This study is an extension of previous parent studies and focuses on the long-term safety and tolerability of TAK-279, as well as its effects on reducing bowel inflammation and symptoms over time. Participants who responded to TAK-279 in the parent studies and completed specified treatment periods are invited to continue treatment in this open-label extension trial. All participants will receive Zasocitinib (TAK-279) capsules orally for up to 156 weeks (about 3 years). This includes those from different parent studies who completed either 12 or 52 weeks of treatment. During the study, participants will visit the clinic around 15 times. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and heart function. They will also evaluate symptom improvements and quality of life using detailed clinical scores and questionnaires. The study aims to understand long-term effects and maintain careful follow-up through regular assessments over the treatment period.

Researchers are evaluating the safety and effectiveness of pulsed field ablation (PFA) therapy for treating persistent atrial fibrillation (PersAF) that does not respond to medication. This study compares two approaches: PFA targeting the pulmonary veins plus electrographic flow (EGF) identified extra-pulmonary vein sources, and PFA targeting the pulmonary veins plus the left atrial posterior wall. The goal is to see if the new method with EGF mapping is at least as effective as the standard approach in managing symptoms of PersAF. Participants will be randomly assigned to one of two groups. The control group will receive pulmonary vein isolation (PVI) plus posterior wall ablation (PWA) using PFA, with EGF mapping performed but not used for treatment decisions. The treatment group will receive PVI plus ablation of active sources identified by EGF mapping. The FARAPOINT catheter may be used for narrow posterior wall channels if found. All subjects will undergo mapping and ablation with devices including the FARAPULSE PFA system and Opal HDx mapping system. Ablation procedures and mapping will be performed according to protocol. During the study, participants will be monitored for safety up to 60 days and effectiveness up to 365 days after treatment. Follow-up will include assessments to track heart rhythm and symptoms, with the use of a LUX-Dx insertable cardiac monitor for continuous monitoring. Participants must be able to comply with follow-up visits and device usage instructions. The study aims to capture data on safety outcomes and measure how well the ablation controls atrial fibrillation over one year.

Researchers are evaluating the effectiveness and safety of volrustomig compared to observation in adults with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). This phase III global study focuses on patients with specific stages of LA-HNSCC and aims to better understand treatment options after initial therapy. Participants are randomly assigned to one of two groups: one group receives volrustomig, a drug being studied, while the other group is placed under observation without additional treatment. The study is open-label and conducted at multiple centers worldwide. The treatment or observation period follows the completion of definitive cCRT with curative intent. During the study, participants undergo regular assessments to monitor progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also track the presence of anti-drug antibodies and measure drug concentrations in blood samples. Safety is monitored by recording adverse events over a period of up to approximately 8 years, allowing long-term evaluation of outcomes and participant well-being.

Researchers are studying the drug duvakitug in a large, Phase 3 clinical trial to assess its effectiveness and safety for people with moderately to severely active Crohn's Disease. This randomized, double-blind, placebo-controlled study aims to evaluate whether duvakitug can help maintain remission and improve symptoms, with important outcome measures including clinical remission and endoscopic response at 40 weeks. Participants receive subcutaneous injections of duvakitug or a placebo according to the study protocol. The trial includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension phase, allowing some participants to continue treatment. Those not entering the extension will have a 45-day follow-up visit. In total, participants may be involved for up to 286 weeks, with up to 43 on-site visits across both phases. During the study, participants undergo clinical evaluations, endoscopic assessments, and symptom monitoring at regular intervals. Researchers will measure clinical remission using CDAI and PRO-2 scores, endoscopic response using SES-CD, and other outcomes such as fatigue, quality of life, bowel urgency, and hospitalization rates. Safety is closely monitored through adverse event tracking and serum drug concentration measurements throughout treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis (UC) in a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study. The study is sponsored by Sanofi and aims to assess how well duvakitug maintains clinical remission and improves symptoms in participants who have responded to prior treatment. This investigation includes a long-term follow-up to understand the treatment's effects over several years. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension (OLE) phase for those who continue treatment. Participants not entering the extension phase will have a 45-day follow-up after the maintenance period. The total treatment duration may be up to 280 weeks, with up to 32 on-site visits during the entire study. During the study, participants will undergo regular assessments including clinical remission measured by the modified Mayo Score, endoscopic and histologic evaluations, symptom tracking like bowel urgency and abdominal pain, and quality of life questionnaires. Safety will be monitored through adverse event reporting and serum drug concentration measurements. The primary outcome is the proportion of participants achieving clinical remission at week 40, and the study will also track long-term safety and efficacy outcomes through the extension phase.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children aged 6 to under 18 years who have severe eosinophilic asthma. This study focuses on patients with a history of asthma attacks and uncontrolled symptoms despite using high-dose inhaled corticosteroids and at least one additional asthma controller medication. The study is a Phase III, randomized, double-blind, placebo-controlled trial designed to measure the time to first asthma exacerbation. The study includes a screening period lasting between 4 to 12 weeks to determine eligibility. Participants are randomly assigned to receive either benralizumab or a placebo injection during the double-blind treatment period, which lasts at least 16 weeks or until an asthma exacerbation occurs. Those who experience an exacerbation during this period may continue treatment in an open-label extension phase lasting at least 48 weeks, followed by an end-of-treatment visit 8 weeks after the last dose. During the study, participants will have regular visits for assessments including asthma control questionnaires, symptom scoring, lung function tests, and blood tests for benralizumab levels and antibodies. Researchers will monitor asthma exacerbations, medication use, night-time awakenings, and quality of life measures. Safety and treatment adherence will be closely observed throughout the study and the extension period, with total participation lasting over a year depending on individual progress.

Researchers are investigating CRB-701, an antibody-drug conjugate targeting nectin-4, in adult patients with advanced solid tumors that express this protein. This three-part, open-label Phase 1/2 trial aims to determine a safe and effective dose of CRB-701 and to understand which cancers might respond to this treatment. The study explores safety, pharmacokinetics, and efficacy to guide future cancer therapies. Participants will receive CRB-701 through intravenous infusion over 30 minutes. The trial includes several dosing groups that range from dose escalation to dose optimization, sometimes combined with an anti-PD-1 drug. Part A focuses on escalating doses to find the maximum tolerated dose, Part B tests dose levels alone or with anti-PD-1 to optimize treatment, and Part C explores the recommended dose in multiple tumor cohorts. During the study, participants will attend clinic visits for infusions and undergo blood tests, CT or MRI scans, and other assessments to monitor tumor response and safety. Researchers will measure the safety, tolerability, and objective response rate to evaluate the treatment’s effect on tumors over periods ranging from 21 days to up to 6 months. The total study duration and monitoring will capture data on efficacy and side effects to support further research.