Heroica Puebla De Zaragoza

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

This research focuses on pediatric participants aged 6 to 17 years with obesity or overweight conditions. Its aim is to establish a framework to evaluate the safety and effectiveness of drug treatments for managing chronic weight issues in this population. The study is part of a Phase 3 Master Protocol that includes multiple interventions and will report results when all intervention-specific arms finish. Participants may receive either Orforglipron, a drug given orally, or a placebo, also taken by mouth. Different intervention-specific arms may begin independently as new treatments become available for testing. The study sets clear entry criteria for newly enrolled participants across these intervention arms. During the study, researchers will monitor participants from baseline up to 72 weeks, focusing on the number of participants allocated to each intervention arm. They will also track safety and treatment effectiveness. Participation involves regular assessments of weight, health status, and any side effects, ensuring a thorough evaluation of the chronic weight management interventions over time.

Researchers are evaluating how well two new study drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. This trial includes participants aged 8 to less than 18 years who have overweight or obesity. The study is designed in two parts: a main study and an extension study. The main study compares CagriSema, cagrilintide, semaglutide (an already approved drug), and placebo, with treatments assigned randomly. Participants receiving semaglutide will not continue to the extension study. The total time in the main study is about 1 year and 6 months, while those in the extension study may participate for up to about 4 years and 10 months. Participants in the main study will receive one of the four treatments by subcutaneous injection. In the extension study, participants will receive either CagriSema or cagrilintide. The study drugs are monitored closely for safety, and participants may experience side effects. The study compares these new treatments to a placebo and an existing approved drug to better understand their effects on weight management in young people. During the study, researchers will measure changes in body mass index (BMI) from baseline to week 68 as the primary outcome. Participants will undergo various assessments including laboratory tests and physical evaluations. The study tracks adherence to treatment and monitors safety throughout the study period. This comprehensive approach aims to provide detailed information about the efficacy and safety of these medications for managing weight in children and adolescents.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are comparing how long participants with KRAS/NRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer remain disease-free and their overall survival time when treated with two different regimens. This phase 3 study focuses on patients who have previously received chemotherapy. The study aims to evaluate progression-free survival and overall survival in participants receiving amivantamab plus FOLFIRI versus cetuximab or bevacizumab plus FOLFIRI. The study involves two treatment groups: one receiving amivantamab combined with chemotherapy drugs 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan (FOLFIRI), and the other receiving either cetuximab or bevacizumab with the same chemotherapy regimen. Participants will be randomly assigned to one of these treatment arms. The treatments will be administered according to protocol to assess their effects on the cancer. Participants will be monitored for up to 2 years and 1 month to measure progression-free survival through blinded independent central review and followed for overall survival for up to 4 years and 4 months. The study includes assessments of tumor response, safety, and other clinical evaluations. Tissue samples and detailed clinical data will also be collected. This comprehensive monitoring will help determine the comparative effectiveness of the treatment options over time.

Researchers are evaluating additional dosing options of dulaglutide in children and adolescents aged 10 to less than 18 years with Type 2 Diabetes. This phase 3, open-label, multicenter study aims to assess the safety, tolerability, how the drug moves through the body, and effectiveness of dulaglutide at doses of 3.0 mg and 4.5 mg in this pediatric population. Participants have Type 2 Diabetes managed with diet, exercise, metformin, and/or basal insulin. Participants will receive dulaglutide administered subcutaneously at either 3.0 mg or 4.5 mg doses. The study is a single-arm design without a placebo or comparative drug group. The treatment period and follow-up last about 8 months. The study monitors participants throughout this time to evaluate the effects and safety of the dosing options. During the study, researchers will regularly assess participants for any serious adverse events related to the study drug from baseline through week 26. Participants will be monitored for safety, tolerability, and drug levels in the body. The main outcome measure is the number of participants experiencing one or more serious adverse events related to dulaglutide. Overall participation in the study lasts approximately 8 months, including screening and treatment.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating how tirzepatide affects body weight and cardiovascular risk factors in adolescents with obesity who also have multiple weight-related health issues. This Phase 3 study aims to assess the safety and effectiveness of tirzepatide combined with healthy nutrition and physical activity. The study includes adolescents aged 12 to 17 years with obesity defined by a high body mass index (BMI) and at least two weight-related comorbidities such as hypertension, prediabetes, or high triglycerides. Participants will receive either tirzepatide or a placebo, both administered by subcutaneous injection once weekly during the primary 72-week study period. Alongside medication, all participants will follow lifestyle interventions focusing on nutrition and physical activity. After completing the initial 72 weeks and a 4-week safety follow-up, eligible participants who have not been off treatment for more than 12 weeks can continue tirzepatide treatment for an additional 156 weeks with ongoing lifestyle support. Throughout the study, up to 23 visits will monitor participants' BMI changes and improvements in weight-related health conditions. Researchers will measure the percentage change in BMI and assess whether participants show significant improvement or normalization in at least two comorbidities without new or worsening conditions over 72 weeks. Safety and efficacy will be closely tracked during the treatment periods and follow-up visits to understand tirzepatide's impact on adolescent obesity and related health risks.

Gastroesophageal reflux disease (GERD) happens when stomach acid or food repeatedly flows back into the esophagus, causing discomfort like heartburn and pain in the stomach, chest, or throat. This condition can affect people of all ages, including children. This research is focused on children aged 2 to 11 years who have symptomatic nonerosive GERD, which means they experience GERD symptoms without damage to the esophagus. The study aims to assess if different doses of the drug dexlansoprazole, adjusted based on body weight, can help relieve these symptoms in children. Participants in this study will receive daily oral doses of dexlansoprazole capsules in one of three amounts: 15 mg, 30 mg, or 60 mg. Children weighing 30 kilograms or less will be randomly assigned to take either 15 mg or 30 mg, while those weighing more than 30 kilograms will be assigned to 30 mg or 60 mg. The medication is taken once daily at the same time throughout the 12-week treatment period. The study will include up to 70 children across multiple centers worldwide. Children and their caregivers will keep an electronic diary to record any heartburn symptoms during the study. The research team will conduct multiple clinic visits over a period of up to 16 weeks, including up to 4 weeks for screening before treatment and a follow-up phone call 5 to 10 days after the final dose. The main outcome measured is the percentage of days without hurting or burning in the stomach, chest, or throat during the 12 weeks of treatment, alongside monitoring for side effects.