Babylon

Researchers are evaluating the safety, tolerability, and effectiveness of EIK1001 combined with standard treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received vein-based treatment for their advanced disease. This phase 2, open-label, multicenter trial includes participants with confirmed stage 4 squamous or non-squamous NSCLC without mutations suitable for first-line targeted therapy. The study aims to find appropriate dosing and monitor adverse events alongside treatment response. Participants receive EIK1001, a Toll-like receptor 7/8 agonist, together with pembrolizumab, a PD-1 inhibitor, and chemotherapy drugs such as paclitaxel, pemetrexed, or carboplatin. These treatments are combined as part of the standard care for stage 4 NSCLC. The trial assesses safety and efficacy over the treatment period, including a dose-finding phase to determine the best dose of EIK1001. During the study, participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, organ function tests, and monitoring of performance status. Researchers track the percentage of participants experiencing safety events throughout up to two years of treatment. Follow-up includes ongoing evaluation of side effects and effectiveness to understand the treatment impact and participant well-being over the course of the trial.

Researchers are evaluating a drug called sigvotatug vedotin alone and in combination with pembrolizumab, with or without chemotherapy, to determine its safety and effects in people with various advanced solid tumors. This Phase 1 study includes participants with specific cancers like non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, esophageal cancers, ovarian cancer, and others. The trial aims to find out the side effects of sigvotatug vedotin and whether it can treat these solid tumors effectively. The study is divided into four parts. Part A focuses on finding the right dose of sigvotatug vedotin. Part B tests the safety and effectiveness of that dose. Parts C and D look at the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with chemotherapy drugs carboplatin or cisplatin. Participants receive these drugs intravenously, with pembrolizumab given every 3 or 6 weeks and chemotherapy every 3 weeks depending on the drug. During the study, participants undergo tumor biopsies, physical exams, and disease assessments to monitor treatment effects. Researchers track side effects, lab abnormalities, and dose-limiting toxicities for up to 30-37 days after the last dose of sigvotatug vedotin, and for up to 3 years after pembrolizumab treatment. The study follows participants with regular safety monitoring and evaluations of tumor response throughout the trial.

Researchers are evaluating the effectiveness of a combination treatment involving adagrasib, pembrolizumab, and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 2 trial focuses on patients with PD-L1 tumor proportion score (TPS) of 1% or higher, but less than 50%, who have not received prior systemic therapy for advanced disease. The study aims to assess how well this combination works as a first treatment option for this patient group. Participants receive adagrasib as oral tablets twice daily at a dose of 400 mg. Pembrolizumab and chemotherapy drugs (pemetrexed and either cisplatin or carboplatin) are given by intravenous infusion once every three weeks. The study includes several groups based on prior treatments and PD-L1 levels, with some participants having previously completed induction chemotherapy. Treatments are administered according to these schedules and patient eligibility. During the study, researchers monitor participants for tumor response and progression-free survival over 30 months. They use standard criteria to measure tumor size changes and disease progression. Assessments include clinical evaluations and imaging to track response to treatment. Safety and tolerability are also monitored throughout the study period to understand the effects of the combination therapy on patients.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo in treating bacterial conjunctivitis in both adults and children. This Phase 3 study aims to show that fusidic acid 1% is superior to placebo for this eye infection, while also establishing its safety when applied directly to the eye. Participants will receive either fusidic acid 1% or a placebo ophthalmic solution as part of a randomized, masked treatment. The study is conducted across multiple centers and includes careful monitoring of treatment effects. The main measure of success is clinical cure assessed on Day 4 after starting treatment. During the study, participants will be closely observed for signs of improvement and safety. They must avoid other ocular treatments, cosmetics, and contact lenses during participation. Researchers will confirm bacterial conjunctivitis through clinical signs and tests to exclude viral causes. The total duration and follow-up procedures are designed to thoroughly evaluate treatment outcomes and safety.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are evaluating the safety and effectiveness of using circulating tumor DNA (ctDNA) testing to guide the start of CDK4/6 inhibitor therapy in people with intermediate-risk hormone receptor-positive, HER2-negative early-stage breast cancer. This study compares results to historical data to see if timing treatment based on ctDNA can maintain cancer control while reducing unnecessary treatment. Participants will be followed for up to nine years with regular blood tests, hormone therapy, imaging as needed, and quality-of-life assessments. Participants will undergo ctDNA testing every three months using the Signatera Genome assay for up to four years. Those who test positive for ctDNA at the start will begin CDK4/6 inhibitor therapy (ribociclib or abemaciclib) along with standard hormone therapy for at least two years. Participants who test negative will continue hormone therapy alone but will have ongoing ctDNA surveillance. If ctDNA becomes positive during monitoring, staging tests will be done to check for distant disease before starting CDK4/6 inhibitor therapy plus hormone therapy. Throughout the study, participants will have regular blood draws and hormone therapy treatments, with imaging performed as needed. Researchers will track invasive disease-free survival for up to nine years from surgery and compare four-year outcomes to historical controls. Safety, treatment adherence, and quality of life will be assessed during follow-up visits over the study period.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved treatment alternatives. This Phase 3, multicenter, randomized, open-label study compares the Bria-IMT regimen combined with the checkpoint inhibitor Retifanlimab against treatment chosen by patients or physicians. The study also aims to assess the activity of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. Participants are initially randomized equally into three groups: Bria-IMT plus Retifanlimab, treatment of physician's choice (TPC), and Bria-IMT alone. After enrollment of 150 patients, the monotherapy group is discontinued, allowing crossover to combination therapy if needed, with subsequent randomization continuing between combination therapy and TPC. Treatment cycles for Bria-IMT with or without Retifanlimab occur every three weeks, including cyclophosphamide given 2-3 days before SV-BR-1-GM inoculations, SV-BR-1-GM administered intradermally, interferon injections at inoculation sites, and Retifanlimab infusions timed consistently each cycle. TPC is given according to standard care at each site using approved drugs including chemotherapy and targeted agents. Participants undergo imaging assessments every six weeks twice, then every eight weeks during treatment if disease is stable and no major safety issues arise. Safety and overall survival will be monitored up to 60 months. Eligibility requires confirmation of advanced breast cancer with prior therapies failed, and participants must have an ECOG performance status of 0 to 2 with expected survival of at least four months. The study includes comprehensive assessments, treatment monitoring, and long-term follow-up to evaluate outcomes and safety.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.