Birkenhead

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 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 12 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 treatments 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.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus MACE-PLUS in adults with established atherosclerotic cardiovascular disease ASCVD or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are comparing two treatments, niraparib and temozolomide TMZ, in adults with newly diagnosed glioblastoma multiforme GBM that has an unmethylated MGMT promoter. This Phase 3 trial aims to find out if niraparib can improve overall survival compared to the current standard treatment, TMZ. The trial will enroll 450 adult participants and is sponsored by the Ivy Brain Tumor Center. Participants will be randomly assigned to receive either niraparib or TMZ. Niraparib is taken orally once daily starting with radiation therapy RT for 6 to 7 weeks and continued as an adjuvant treatment until cancer progression or discontinuation. The TMZ group receives the drug daily during RT, followed by a rest period and then up to 6 cycles of adjuvant TMZ. Radiation therapy is given as standard care to 60 Gy in 30 fractions. During the study, participants will complete scheduled visits and keep a diary to record medication use. Researchers will monitor overall survival over 24 months as the primary outcome. Secondary measures include progression-free survival, response rates, quality of life assessments, neurocognitive function tests, and tracking of adverse events. Safety and treatment effects will be closely observed throughout the trial period, which continues until March 2028.

Researchers are evaluating the anti-tumor activity of adding amivantamab to pembrolizumab and carboplatin compared to pembrolizumab combined with 5-fluorouracil and platinum therapy carboplatin or cisplatin in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have not received prior systemic treatment in this setting. HNSCC is a cancer affecting areas such as the mouth and throat. This phase 3, randomized, open-label study aims to better understand treatment options for this condition. Participants are assigned randomly to one of two treatment groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other group receives pembrolizumab, 5-fluorouracil administered via a 4-day infusion, and either carboplatin or cisplatin. The treatments are given as part of standard care agents, and the study compares these combinations to assess their effects and safety over time. Throughout the study, participants will be monitored for overall survival and tumor response using established criteria over approximately three years and seven months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires focusing on symptoms and functioning, and safety evaluations such as adverse event tracking and laboratory testing. Blood samples will also be collected to measure amivantamab concentration and antibodies. The study involves multiple visits and evaluations to thoroughly assess the treatments impact and participant well-being.

Researchers are evaluating the drug CC-97540 in people aged 16 and older who have active systemic lupus erythematosus SLE, including lupus nephritis, and who have not responded well to glucocorticoids and at least two immunosuppressant treatments. This Phase 2 study aims to assess the effectiveness, safety, and drug levels of CC-97540 in this group. The study is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Participants will receive CC-97540, a type of CD19-targeted NEX-T CAR T cell therapy, along with specified doses of fludarabine and cyclophosphamide on scheduled days. The study is open-label and multicenter, meaning both participants and researchers know which treatment is given. The treatments are designed to evaluate disease control and remission in participants with inadequate prior responses. The study includes multiple assessments over a period of up to 60 months to monitor various health outcomes. Throughout the study, participants will be closely monitored with regular assessments, including measuring drug-free remission rates, kidney response in lupus nephritis cases, disease activity, and patient-reported outcomes like fatigue and pain. Laboratory tests will track kidney function, autoantibody levels, and immune system markers. Safety is carefully observed by recording adverse events and lab abnormalities. The total participation duration can last up to 60 months, allowing thorough evaluation of long-term effects and disease status.

Researchers are evaluating the immune response and safety of the mRNA-1018-H5 vaccine against pandemic influenza in healthy adults aged 18 years and older. The study aims to measure how well the vaccine triggers protective antibodies and to monitor any side effects or reactions. This is a phase 3 randomized trial sponsored by ModernaTX, Inc., focusing on adults without significant health issues or with stable chronic conditions. Participants will be randomly assigned to receive either the mRNA-1018-H5 vaccine or a placebo. Both are given as intramuscular injections on Day 1 and Day 22. The vaccine is a sterile liquid designed for injection. The study includes a blinded design to ensure unbiased safety and immunogenicity assessments. Participants may be monitored for up to 205 days to assess antibody levels and adverse events. During the study, participants will have blood tests to measure antibody responses on Days 22, 43, and 205. Researchers will track local and systemic reactions for 7 days after each injection and any adverse events for up to 205 days. The main outcomes include the percentage of participants achieving protective antibody levels, immune response strength, and safety measures. Participants will be involved in regular visits and evaluations throughout the study period.

Researchers are evaluating new treatments and combinations for people with metastatic colorectal cancer mCRC in this Phase II, global study. The study focuses on participants with Mismatch-repair-proficient pMMR and Microsatellite stable MSS mCRC who have not received previous systemic treatment for advanced disease and do not have liver metastases. The goal is to assess the safety and effectiveness of these treatments in this specific group. Participants are randomly assigned to one of two groups one group receives the study drug volrustomig combined with FOLFIRI a chemotherapy regimen including irinotecan, 5-fluorouracil, and leucovorin and bevacizumab, while the other group receives only FOLFIRI and bevacizumab. All drugs are administered by intravenous infusion. This master protocol includes multiple substudies and will compare the treatment effects over approximately three years. During the study, participants will undergo regular assessments including scans to measure disease progression, safety monitoring for adverse events, and laboratory tests to track drug levels and immune responses. Researchers will measure progression-free survival and record any side effects throughout about three years of follow-up. Additional outcomes like overall survival, response rates, and duration of response will also be evaluated. Participants health status and organ functions will be monitored to ensure ongoing safety.

This trial investigates whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer NSCLC remain cancer-free longer than those receiving pembrolizumab with a placebo. It focuses on patients whose tumors did not completely respond to treatment before surgery. The study is a Phase 3, randomized, double-blind trial assessing adjuvant therapy following neoadjuvant treatment and surgery in resectable Stage II to IIIB NSCLC without complete pathological response. Participants first receive neoadjuvant treatment with pembrolizumab and chemotherapy every 3 weeks for up to 4 cycles, lasting about 12 weeks. After surgery, they get adjuvant treatment with pembrolizumab every 6 weeks for up to 7 cycles, combined with either intismeran autogene or placebo given by intramuscular injection every 3 weeks for up to 9 doses, for a total of about 42 weeks. The study compares these two groups to evaluate the impact on cancer recurrence. During the trial, participants undergo regular evaluations including disease-free survival monitoring for up to approximately 97 months, and other measures like overall survival, metastasis-free survival, and quality of life assessments for up to around 129 months. Safety is tracked by recording adverse events and therapy discontinuations. Follow-up involves questionnaires and clinical tests to assess health status and treatment effects over the long term.

Researchers are evaluating the safety and effectiveness of ruxolitinib cream in children and adolescents aged 6 to under 18 years with moderate atopic dermatitis. This condition involves skin inflammation and itching, and the study aims to provide new treatment options by comparing ruxolitinib cream to a matching vehicle cream. The trial is a Phase 3b, randomized, double-blind study sponsored by Incyte Corporation. Participants will be assigned randomly to receive either ruxolitinib cream or a vehicle cream. The creams will be applied twice daily or twice weekly depending on the study period. The study includes a vehicle-controlled phase and a disease control phase, with an open-label extension period where all participants may receive ruxolitinib cream. The treatment regimen also allows twice-daily application during disease flare-ups. During the study, participants will regularly visit the clinic for assessments including skin evaluations using the Eczema Area and Severity Index EASI, Investigators Global Assessment, itch severity ratings, and quality of life questionnaires. Blood samples will be taken to measure drug levels and safety labs. The study will monitor adverse events and disease flare-ups for up to 70 weeks. Participants and their guardians will keep diaries to track symptoms and cream usage throughout the trial.