Birkenhead

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 CRB-701, an antibody-drug conjugate targeting nectin-4, in adults with advanced solid tumors that express nectin-4. This Phase 1/2 clinical trial aims to find a safe and effective dose of CRB-701 and to determine which cancers might respond to this treatment. The study includes three parts focusing on safety, dosing, and effectiveness, especially for tumors resistant to other treatments or lacking standard therapies. The study is divided into three parts. Part A involves escalating doses of CRB-701 alone to identify the maximum tolerated dose and recommended dose for further study. Part B tests two dose levels of CRB-701 alone and combined with an anti-PD-1 checkpoint inhibitor to optimize dosing. Part C further explores CRB-701 alone or with anti-PD-1 in up to seven groups of participants. Treatments are given by intravenous infusion. Participants will attend clinic visits for infusions and undergo various tests including blood work, CT or MRI scans, and other assessments to monitor tumor response and safety. The main outcomes measured are dose safety, tolerability, and objective tumor response over periods ranging from 21 days to up to 6 months. Ongoing monitoring includes safety assessments and evaluation of treatment effects 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.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.

Researchers are evaluating the effectiveness of niraparib compared to temozolomide (TMZ) in adults recently diagnosed with MGMT unmethylated glioblastoma multiforme (GBM). This Phase 3 trial aims to determine if niraparib can improve overall survival compared to the standard treatment with TMZ. The study will enroll 450 participants who have not received prior GBM treatment except surgery or biopsy. Participants will be randomly assigned to receive either niraparib or TMZ. Niraparib will be taken orally at 200 mg once daily starting on the first day of radiation therapy (RT) and continued daily during RT for 6-7 weeks, followed by adjuvant niraparib taken daily on Days 1 to 28 of each 28-day cycle until disease progression. The TMZ group will receive 75 mg/m2 orally once daily with RT, then after a 4-week rest, will take adjuvant TMZ 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for up to 6 cycles or until progression. Participants will complete scheduled study visits and keep a diary recording their study medication intake. Researchers will monitor overall survival over 24 months and assess safety and efficacy throughout the study period. Participants must meet specific health and diagnostic criteria and will be closely followed for treatment effects and adverse events.

Researchers are evaluating the anti-tumor activity of amivantamab combined with pembrolizumab and carboplatin compared to pembrolizumab, 5-fluorouracil (5-FU), and platinum therapy (carboplatin or cisplatin) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial focuses on participants who have not received prior systemic treatment in the recurrent/metastatic setting. HNSCC is a type of cancer affecting the outer tissue layer of the mouth and throat and other head and neck regions. Participants will receive either amivantamab added to pembrolizumab and carboplatin or the standard care regimen of pembrolizumab, 5-FU, and a platinum agent (carboplatin or cisplatin). 5-FU will be given as an infusion over a 4-day period. The study is a phase 3, randomized, open-label, multicenter trial comparing these treatment combinations. During the study, researchers will monitor overall survival and the objective response rate using standard tumor evaluation criteria for up to about 3 years and 7 months. Participants will undergo assessments to measure disease response, including imaging and other evaluations, to track how well the treatments work. Safety and side effects will also be monitored throughout the trial period.

Researchers are studying the effectiveness and safety of CC-97540, a CD19-targeted NEX-T CAR T cell therapy, in people with active systemic lupus erythematosus (SLE), including lupus nephritis. This phase 2, open-label trial focuses on participants who have not responded well to glucocorticoids and at least two immunosuppressant treatments. The goal is to assess whether CC-97540 can help achieve drug-free remission of SLE symptoms within six months. Participants receive CC-97540 along with specified doses of fludarabine and cyclophosphamide on certain days as part of the treatment. The study involves multiple centers and includes patients with active disease despite current treatment. The dosing schedule and exact administration details are defined to evaluate the therapy's effects and monitor drug levels. During the study, participants are closely monitored for safety and response to treatment. Researchers measure the proportion of participants who reach remission without the need for drugs by month six. The study includes assessments of disease activity and organ function, with ongoing observation to understand the therapy's impact on lupus symptoms and potential side effects over time.

Researchers are studying the immune response and safety of mRNA-1018-H5, a pandemic influenza vaccine, in adults aged 18 years and older. The trial aims to assess how well two doses of this vaccine trigger antibody production and to monitor any side effects or reactions. This is a Phase 3, randomized, observer-blind, placebo-controlled study focused on the influenza virus. Participants will receive either the mRNA-1018-H5 vaccine or a placebo, both provided as sterile liquid injections. The study involves two doses and includes detailed monitoring for immune response and side effects after vaccination. The trial compares the vaccine to a placebo to evaluate its immunogenicity and safety. During the study, individuals will undergo medical evaluations including physical exams and pregnancy testing if applicable. Researchers will measure antibody levels at Day 43 and record any local or systemic reactions up to Day 29 after injections, as well as any adverse events up to Day 205. The study tracks serious and medically-attended adverse events to ensure careful safety monitoring throughout the participation period.

Researchers are evaluating the safety and effectiveness of new treatment combinations for participants with metastatic colorectal cancer (mCRC). This Phase II global study uses a master protocol with substudies focused on participants who have mismatch-repair-proficient (pMMR) or microsatellite stable (MSS) mCRC without liver metastases and who have not previously received systemic treatment for advanced disease. Participants will be randomly assigned to one of two treatment groups: one receiving Volrustomig combined with FOLFIRI (a regimen of irinotecan, fluorouracil, and leucovorin) plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab only. All medications will be given as intravenous infusions. This modular study takes place across multiple centers worldwide. During the approximately three-year participation, researchers will measure progression-free survival and monitor adverse events. Participants will undergo regular evaluations including tumor assessments by RECIST 1.1 criteria and organ function tests. Safety and treatment effects will be closely observed throughout the study period to understand the impact of these new treatment combinations.

Researchers are evaluating whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) remain cancer-free longer compared to pembrolizumab with a placebo. This study focuses on patients with NSCLC whose tumors did not completely respond to treatment before surgery and aims to prevent the cancer from returning. It is a Phase 3 randomized, double-blind study involving participants with resectable Stage II to IIIB (N2) NSCLC. Participants receive treatments including pembrolizumab given as an intravenous infusion and either intismeran autogene or placebo administered as an intramuscular injection. Before surgery, patients have received neoadjuvant pembrolizumab combined with platinum-based doublet chemotherapy, but only those who did not achieve a complete pathological response are eligible. The study compares the effects of pembrolizumab with or without intismeran autogene following surgery. During the study, participants are closely monitored for disease-free survival over a period of up to approximately 97 months. Researchers will assess whether the cancer returns and evaluate overall safety. Participants undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the study period.