Natori

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma HNSCC. This Phase 3 randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-L1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating the effectiveness and safety of combining calderasib with pembrolizumab as the first treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. The study compares this combination to pembrolizumab with a placebo to see if it improves the time participants live without the cancer worsening and overall survival. Participants receive pembrolizumab through an intravenous infusion every 21 days for up to 35 cycles. They also take calderasib or a matching placebo by mouth daily until they meet criteria to stop treatment. The study is randomized and double-blind, meaning neither participants nor researchers know who receives calderasib or placebo. During the study, participants will have regular assessments to monitor cancer progression, overall survival, response rate, and quality of life measures through questionnaires. Safety will be closely monitored by tracking adverse events and treatment discontinuations. The study may last up to about 56 months, including follow-up to observe long-term outcomes and quality of life changes.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Non-small cell lung cancer NSCLC is the most common lung cancer type, and this study focuses on people with NSCLC whose tumors have a specific faulty KRAS G12D gene mutation. Researchers are comparing a new drug called setidegrasib to the standard treatment docetaxel in adults with advanced or metastatic NSCLC who have already received chemotherapy and immunotherapy. The goal is to see if setidegrasib can help people live longer without their cancer worsening and to evaluate other effects on symptoms, tumor response, and safety. Participants in the study will be randomly assigned to receive either setidegrasib or docetaxel, both given through intravenous infusions. Setidegrasib is given on days 1, 8, and 15 of each 21-day cycle, while docetaxel is given on day 1 of each 21-day cycle. Treatment continues until the cancer progresses, side effects prevent continuation, or other stopping reasons occur. Some participants initially on docetaxel may switch to setidegrasib if their cancer worsens. Safety checks and monitoring occur regularly throughout the study. During the study, participants will have tumor scans every 6 weeks for the first year, then every 9 weeks until their cancer progresses. After progression, clinical staff will follow up by phone every 12 weeks. Researchers will assess how long participants live without cancer progression and overall survival, along with symptom changes, tumor response, quality of life, and side effects. The study may last up to several years, with ongoing evaluation of participant health and treatment effects.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the long-term safety of nivolumab alone or in combination with other cancer therapies in patients with various tumor types. This Phase 2 study focuses on monitoring the effects and side effects of these treatments over an extended period to understand their safety profiles better. Participants receive one of several treatment regimens involving drugs such as nivolumab, ipilimumab, cabozantinib, trametinib, relatlimab, and others. Each treatment is given at specified doses on set days, with some regimens combining multiple drugs. The study includes patients who have previously participated in Bristol-Myers Squibb sponsored trials and may continue or restart treatment based on prior response. Throughout the study, participants undergo regular safety assessments to track adverse events, including serious, immune-mediated, and drug-related side effects. Monitoring continues from the first day of treatment up to 135 days after stopping treatment to assess the incidence of adverse events and deaths. This comprehensive safety monitoring helps researchers understand the long-term effects of these cancer therapies over several years.

This research observes patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors, excluding colorectal cancer, to monitor the safety and effectiveness of dabrafenib and trametinib. It is a prospective, multicenter, single-arm, non-interventional observational study that collects real-world data under current medical practices. The study is conducted using an electronic data capture system and aims to gather long-term information especially in pediatric patients. Participants receive dabrafenib and trametinib as prescribed according to the Japanese Package Insert without treatment assignment by the study. Adult patients are observed for one year after starting treatment, while pediatric patients are followed for up to eight years regardless of whether they continue treatment, to collect extensive safety and response data during the reexamination period. The study aims to include approximately 65 adults and about 20 pediatric patients. During the study, researchers collect data on adverse events related to skeletal and sexual maturation in pediatric patients, overall response rate in adults, progression-free survival, changes in height and weight, and other safety outcomes. Data collection occurs throughout the observation periods for both adult and pediatric patients. The study is sponsored by Novartis Pharmaceuticals and is designed to provide important long-term safety and effectiveness information on these medications used in routine care.

Multiple myeloma is a cancer affecting plasma cells in the bones and bone marrow, causing bone pain, fractures, infections, weak bones, and kidney failure. This study is evaluating the investigational drug etentamig compared to standard available therapies in adults with relapsed or refractory multiple myeloma. The study aims to understand changes in disease symptoms and treatment effects over time in this population. Participants are randomly assigned to one of two groups Arm A receives etentamig as an intravenous infusion given in 28-day cycles, and Arm B receives standard available therapies chosen by the investigator based on local guidelines. The study will last about 3.5 years, with treatments and monitoring continuing throughout this period. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure outcomes such as progression-free survival, response rates, overall survival, symptom changes, and quality of life using questionnaires and clinical tests. The study includes careful safety monitoring and may involve more treatment visits than standard care.