Puducherry

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 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 conducting a Phase I open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adults with relapsed advanced malignancies. The study focuses on patients with selected advanced solid tumors, such as non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer, who have no curative or life-prolonging treatment options left. This first-in-human trial aims to find the best dose of AUR107 using a traditional dose-escalation design. Participants will receive oral AUR107 once daily at escalating doses ranging from 5 mg to 200 mg. The trial follows a 33 dose escalation design to evaluate safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The study is multicenter and includes dose expansion following dose escalation. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over 28-day cycles. Researchers will measure pharmacokinetic parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and elimination half-life at various time points under fasting and fed conditions. Safety assessments and clinical evaluations will be conducted throughout the study, which is expected to continue until June 2027.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

This trial investigates the effectiveness and safety of two treatment combinations for people with relapsed or refractory multiple myeloma who have received one to three prior treatments and were previously treated with lenalidomide. It compares mezigdomide, bortezomib, and dexamethasone MeziVd against pomalidomide, bortezomib, and dexamethasone PVd to see which is better for this condition. The study is a Phase 3, randomized, open-label trial sponsored by Celgene. Participants receive either the MeziVd combination or the PVd combination, with specified doses given on certain days according to the study plan. These treatments are given as drugs, and participants are randomly assigned to one of these two groups to compare their effects. The study will continue for up to approximately five years to evaluate long-term outcomes. During the study, participants will be monitored regularly through various assessments including measuring disease progression, survival, response to treatment, and quality of life using specific questionnaires EORTC QLQ-C30 and QLQ-MY20. Blood samples may be checked for drug levels, and adverse events will be tracked. The main focus is progression-free survival, measured from randomization until disease worsening or death. Participants health and responses will be followed for up to five years, with ongoing visits and evaluations throughout this period.

This trial studies participants with previously untreated, unresectable, or metastatic colorectal cancer. It evaluates the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy. The study includes participants who do not have specific genetic markers like dMMR, MSI-H, or BRAF V600E mutations, which may affect treatment response. Participants receive treatment with study drugs such as pumitamig, bevacizumab, and chemotherapy regimens including FOLFOX, FOLFIRI, and CAPOX. The treatments are given at specified doses on specific days. The study uses a randomized, double-blind design with multiple experimental and comparator arms to assess these combinations. Throughout the study, participants undergo regular assessments to measure tumor response and survival outcomes. Key evaluations include imaging tests using RECIST v1.1 criteria, monitored by both investigators and independent reviewers, over a period of up to 5 years. Researchers track objective response, progression-free survival, and overall survival to determine treatment outcomes and safety.

This trial investigates the safety and efficacy of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Participants must have specific tumor characteristics including PD-L1 and HER2 status, and measurable disease according to established criteria. The study is a blinded, randomized phase 23 trial sponsored by Bristol-Myers Squibb. Participants will receive either Pumitamig or Nivolumab alongside chemotherapy regimens such as Folfox or Capox, with dosing given on specified days. The study uses a parallel design with multiple experimental arms to evaluate these combinations. Treatments and assessments will continue over several months following randomization. During the study, participants will undergo regular evaluations including tumor response assessments by RECIST criteria, survival monitoring, and safety checks. Researchers will measure objective response rates, progression-free survival, and overall survival up to several years after treatment starts. The trial includes long-term follow-up to monitor outcomes and safety over time, with the primary outcome tracked for up to two years after the last participant is randomized.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are evaluating the safety and effectiveness of darolutamide alongside standard androgen deprivation therapy ADT in Indian men with high-risk non-metastatic castration-resistant prostate cancer nmCRPC. This type of prostate cancer continues to progress despite very low testosterone levels. The study aims to collect detailed safety data and compare it with previous research involving darolutamide, which did not include Indian participants. Participants will take darolutamide tablets orally twice daily along with their ongoing ADT. They will have visits every 16 weeks from the start until their cancer worsens, they develop medical issues, leave the study, or the study ends. During these visits, various tests and assessments will be performed, including blood and urine sampling, physical exams, heart activity monitoring with ECG, and evaluation of daily living abilities using the ECOG performance status. Throughout the study, researchers will monitor adverse events, lab abnormalities, vital signs, and changes in participants health status up to approximately 15 months. They will also assess changes in prostate-specific antigen PSA levels and track the time to additional cancer treatments. Participants may continue darolutamide after the trial if they benefit from it. The total study duration extends up to the primary completion date in April 2027.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.