Thanh Pho Vinh

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

This research is investigating the safety and effectiveness of combining Trastuzumab deruxtecan T-DXd with rilvegostomig, compared to T-DXd alone or the standard chemotherapy regimen of gemcitabine plus cisplatin with durvalumab in patients who have advanced HER2-expressing biliary tract cancer and have not received prior treatment. The study focuses on patients with unresectable, locally advanced, or metastatic biliary tract adenocarcinoma that expresses HER2 protein. Participants are randomly assigned to one of three groups one receiving T-DXd combined with rilvegostomig, another receiving T-DXd alone, and a third group receiving standard chemotherapy with gemcitabine and cisplatin plus durvalumab. All therapies are given by intravenous infusion. The study includes an initial safety run-in phase where participants complete at least one 21-day treatment cycle, followed by a randomized portion that will assess overall survival and other efficacy measures over an estimated period of up to 50 months. During the study, participants will undergo assessments including tumor tissue testing to confirm HER2 expression, evaluations of tumor lesions using RECIST criteria, and monitoring of physical function and adverse effects. Blood samples will be collected to analyze drug levels and immune responses. Researchers will track overall survival, progression-free survival, response rates, and patient-reported tolerability throughout the treatment and up to the studys end. The study duration extends until the final data collection, which may be up to several years after enrollment.

Researchers are evaluating the safety and effectiveness of datopotamab deruxtecan Dato-DXd compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer NSCLC that tests positive for trophoblast cell surface protein 2 TROP2 but lacks actionable genomic alterations. This phase III, randomized, open-label study also aims to assess the clinical performance of an investigational diagnostic test related to TROP2 expression. Participants will be randomly assigned to receive either Dato-DXd or docetaxel as an intravenous infusion every three weeks. Each treatment is given on Day 1 of a 21-day cycle. The study includes two groups one receiving Dato-DXd monotherapy and the other receiving docetaxel monotherapy. The study will continue until disease progression or other discontinuation criteria are met. Throughout the study, participants will undergo regular assessments to measure progression-free survival and overall survival over approximately 2.5 to 3.5 years. Additional evaluations include response rates, duration of response, symptom assessments, quality of life questionnaires, and biomarker analyses. Safety monitoring and diagnostic testing will also be conducted. The total participation time will depend on individual treatment duration and follow-up requirements.

Researchers are evaluating the safety and effectiveness of combining osimertinib tablets with Datopotamab Deruxtecan intravenous infusion compared to using osimertinib tablets alone as a first treatment for participants with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific EGFR mutations Ex19del andor L858R. This global Phase III, open-label, randomized study targets participants who have not yet received treatment for advanced disease and aims to assess how well this combination works and how safe it is over an estimated 8-year event-driven study duration. Participants will be randomly assigned to one of two groups one will receive osimertinib 80 mg orally once daily combined with Datopotamab Deruxtecan 6 mgkg by intravenous infusion every three weeks, while the other will receive osimertinib 80 mg orally once daily alone. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During treatment, visits occur every three weeks. For those receiving osimertinib alone or who stop Datopotamab Deruxtecan but remain on osimertinib, visits become every six weeks from cycle 7 to cycle 17 and then every twelve weeks until disease progression or stopping treatment. Participants will undergo regular assessments including scans and tests to monitor disease status and treatment effects as per the study schedule. Researchers will measure progression-free survival, overall survival, response rates, and other outcomes related to the cancer and treatment effects. Safety and drug levels will also be monitored. Participants can expect frequent visits and evaluations throughout the study, lasting up to about eight years or until specific stopping criteria are met.

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.