Biga

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness and safety of CYP-001 combined with corticosteroids compared to corticosteroids alone in adults who have undergone allogeneic hematopoietic stem cell transplant and developed high-risk acute graft versus host disease (aGvHD). This phase 2, randomized, double-blind, placebo-controlled study assesses the severity of aGvHD using the Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines throughout the trial. Participants will be randomly assigned to receive either CYP-001, an intravenous infusion of induced pluripotent stem cell-derived mesenchymal stem cells, on Days 0 and 4 along with corticosteroids, or a placebo infusion on the same days plus corticosteroids. All subjects will receive corticosteroids at a minimum dose of oral prednisone 2 mg/kg/day or methylprednisolone 1.6 mg/kg/day intravenously as appropriate. The treatment phase includes study visits up to Day 100, followed by a long-term follow-up period with visits extending to 24 months. During the study, participants will undergo regular assessments to monitor the response to treatment and the severity of aGvHD. Researchers will evaluate the overall response rate at 28 days as the primary outcome. Safety and long-term effects will also be monitored throughout the follow-up period, ensuring comprehensive evaluation of both immediate and extended treatment impacts.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years who have severe uncontrolled asthma. These children must be on medium to high doses of inhaled corticosteroids along with at least one other asthma controller medication, with or without oral corticosteroids. This phase 3, multicenter, double-blind, placebo-controlled study aims to better understand how tezepelumab affects asthma control in this pediatric population. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo for 52 weeks during the double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in phase. After the treatment period, a 12-week follow-up phase occurs without treatment. Eligible participants can then join an optional open-label extension, receiving tezepelumab for an additional 104 weeks followed by another 12-week post-treatment follow-up. Throughout the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. Researchers will measure the annualized rate of severe asthma flare-ups from the start of treatment to week 52. Safety and treatment adherence will also be closely monitored during all study phases, with total participation potentially extending over two years for those in the extension period.

Researchers are evaluating the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab compared to standard nivolumab treatments in people who have advanced melanoma that has not been treated before. This study focuses on participants who have a specific genetic marker called HLA-A*02:01 and aims to understand how these treatments affect the progression of their cancer. The study is a phase 3, randomized, controlled trial, which helps ensure reliable comparison between the different treatment regimens. Participants in this study will receive either brenetafusp plus nivolumab or standard nivolumab regimens, which may include nivolumab alone or in combination with relatlimab. These treatments are given by intravenous infusion, with specific dosing of the drugs as concentrates for infusion. The study compares these approaches to see which is more effective in controlling the melanoma. During the study, participants will be closely monitored for disease progression and overall health. Researchers will use scans and other assessments to measure progression-free survival, which is the time participants live without their disease worsening, followed for up to about 45 months. Safety and response to treatment will be regularly evaluated to better understand the effects of the therapies over time.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.

Researchers are evaluating new combinations of treatments for people with non-small-cell lung cancer (NSCLC), including those with metastatic (spread) cancer and those with resectable stage II-III NSCLC. This Phase 2 platform trial has three substudies: Substudy-01 compares novel treatments to standard care in patients with untreated metastatic NSCLC; Substudy-02 focuses on patients whose metastatic NSCLC progressed after previous treatment; and Substudy-03 studies patients with resectable NSCLC before surgery. The main goals are to assess tumor response rates and, for Substudy-03, the complete pathological response rate after treatment. The trial tests multiple drugs administered intravenously or orally, including zimberelimab, domvanalimab, sacituzumab govitecan-hziy, etrumadenant, carboplatin, cisplatin, pemetrexed, paclitaxel, nab-paclitaxel, docetaxel, and nivolumab. Patients receive these treatments in various combinations depending on their substudy group. Substudy-03 participants undergo planned surgery such as lobectomy after treatment. The study compares these novel combinations against standard therapies to evaluate their safety and effectiveness. Participants will be monitored for up to five years with assessments of tumor response using standard criteria (RECIST v1.1) and pathological analysis for complete response where applicable. Researchers will collect data on treatment effects, safety, and disease progression throughout the study. Participants must undergo scans, laboratory tests, and clinical evaluations regularly to track their condition and response to treatment during this long-term follow-up period.