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Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer mNSCLC whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are studying the real-world effectiveness, safety, and patient experience of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating treatments for advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary. The study focuses on patients with no visible tumor remaining after primary tumor debulking surgery. It aims to compare the time patients remain free from cancer recurrence when treated with different lengths of chemotherapy followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two groups. One group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib is taken orally daily, starting at a dose of either 200 mg or 300 mg. Treatment continues until disease progression, unacceptable side effects, or other stopping reasons. Tumor assessments using CT or MRI scans and blood tests for the tumor marker CA-125 are performed regularly to monitor disease status. During chemotherapy, clinical visits including blood tests and toxicity monitoring occur every 3 weeks, and pregnancy tests are done every 4 weeks for women of childbearing potential. During niraparib maintenance, visits and safety monitoring happen every 4 weeks for the first 11 months, then every 12 weeks afterward. Physical exams take place every 12 weeks. Safety is closely monitored through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in Europe, with follow-up lasting up to 8 years to assess recurrence-free survival and other outcomes.

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 evaluating treatments for participants with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC in this Phase III, randomized, open-label, international study. The study aims to compare the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with durvalumab against investigators choice chemotherapy combined with pembrolizumab, and also evaluates Dato-DXd alone. The main goal is to assess whether Dato-DXd with durvalumab helps participants live longer without their cancer worsening or improves overall survival compared to the standard chemotherapy plus pembrolizumab. Participants are assigned to one of three treatment groups Dato-DXd combined with durvalumab investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with pembrolizumab or Dato-DXd alone. All treatments are given by intravenous infusion. The study includes stratification by geographic location, disease-free interval history, and prior PD-1PD-L1 treatment for early stage TNBC. Throughout the study, participants will undergo regular assessments including imaging to measure cancer progression, laboratory tests, and evaluations of symptoms and quality of life. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and time to deterioration in symptoms such as pain and physical functioning. Safety and tolerability of the treatments will also be closely observed. Participation may last up to several years with ongoing follow-up to capture long-term outcomes.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating the safety and effectiveness of various targeted therapies and immunotherapy combinations in adults with metastatic colorectal cancer mCRC whose tumors show specific biomarkers. This open-label, exploratory Phase 1 study aims to understand how these treatments work in different patient subgroups based on their tumors genetic characteristics. Participants are assigned to treatment groups depending on their biomarker test results. Participants receive different combinations of drugs such as inavolisib, cetuximab, bevacizumab, atezolizumab, tiragolumab, SY-5609, divarasib, FOLFOX, and FOLFIRI. Treatments may be given orally or by intravenous infusion following specific schedules, with cycles lasting 21 or 28 days depending on the regimen. Some treatment arms are closed, while others are active or recruiting participants. Throughout the study, participants undergo regular assessments including tumor measurements to evaluate response rates. Researchers monitor safety by tracking adverse events and measure drug levels in the blood at set intervals. The primary outcome is the objective response rate over approximately 84 months, with secondary outcomes including duration of response, disease control rate, and recommended doses for some drug combinations. The study lasts several years, with ongoing monitoring of participants health and tumor status.

Researchers are evaluating the effectiveness and safety of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as first-line treatment for patients with advanced biliary tract cancer BTC. This phase III study aims to understand which treatment provides better overall survival and disease control for this condition. The trial focuses on patients with advanced BTC, including intra-hepatic or extra-hepatic cholangiocarcinoma and gallbladder carcinoma, who have not previously received systemic therapy for advanced disease. Participants receive either rilvegostomig or durvalumab through intravenous infusion alongside chemotherapy with gemcitabine and cisplatin. Durvalumab is given at 1500 mg intravenously every three weeks for up to eight cycles, then every four weeks thereafter. Gemcitabine and cisplatin are administered intravenously on days 1 and 8 of each 21-day cycle. The study compares these two treatment combinations to assess their impact on survival and disease progression. During the study, patients will be closely monitored for overall survival, progression-free survival, response rates, and treatment safety over approximately four years. Additional assessments include measuring drug levels in the blood, evaluating patient-reported symptoms and quality of life, and tracking the duration of response. Regular imaging scans and laboratory tests will be conducted to measure disease status and organ function. Safety and tolerability of the treatments will also be carefully observed throughout the trial period.

Researchers are evaluating the efficacy and safety of ifinatamab deruxtecan I-DXd in people with various recurrent or metastatic solid tumors, including endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinomas of the esophagus, gastroesophageal junction and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low and HER2 immunohistochemistry 0 breast cancer, and cutaneous melanoma. This Phase 1B2 study is divided into two parts, Stage 1 and Stage 2, with safety and efficacy data guiding progression between stages. A safety run-in phase will assess I-DXd tolerability specifically in hepatocellular carcinoma. Participants receive intravenous infusions of I-DXd, typically at 12 mgkg, except for hepatocellular carcinoma where dosing is determined separately. The treatment is given to participants who have been previously treated with one or more systemic therapies for their tumor type. Each tumor type forms a separate cohort, and participants receive the study drug in repeated cycles as per protocol. Throughout the study, participants will be monitored for tumor response, safety, and side effects. Assessments include imaging scans to measure tumors, laboratory tests, and evaluations of adverse events. Pharmacokinetic analyses will measure drug concentrations over time. The primary outcome is the objective response rate, with follow-up lasting up to approximately 57 months. Safety data are collected up to 47 days after the last dose, and long-term monitoring includes survival and disease progression evaluations.

Researchers are evaluating the safety and effectiveness of BioPearl183 microspheres loaded with Doxorubicin in treating adults with unresectable hepatocellular carcinoma HCC, a type of liver cancer that cannot be removed surgically. This study aims to confirm the safety and technical success of this treatment while also investigating its ability to control tumor growth and improve survival. The study is conducted after the medical device has been approved for market use. The treatment involves a procedure called Transarterial Chemo Embolization TACE, where BioPearl183 microspheres loaded with the chemotherapy drug Doxorubicin are delivered directly to the liver tumors. This is a single group study including about 50 participants who will receive this treatment. During the study, participants will undergo clinical follow-up until their disease progresses or they require another treatment, with survival monitoring continuing up to 18 months. An interim safety and technical success review will occur during enrollment. Participants will be regularly evaluated for safety by monitoring any serious adverse events related to the procedure or device within the first month. Effectiveness will be measured through tumor response, time until disease progression, duration of response, and survival rate over 18 months. Follow-up includes clinical visits and assessments to track disease status and treatment outcomes. The study aims to provide detailed information on both the safety and benefits of BioPearl183 microspheres in this liver cancer treatment setting.