Pesaro

This trial enrolls participants from previous studies evaluating adagrasib either alone or combined with other cancer therapies in patients with non-small cell lung cancer, colorectal cancer, and other advanced solid tumors. It is an open-label continuation study designed to provide long-term treatment for cancer patients who have already participated in those parent trials. The study is sponsored by Mirati Therapeutics Inc. and focuses on treatment of solid tumors. Participants receive adagrasib and may also receive other cancer drugs such as pembrolizumab, cetuximab, pemetrexed, docetaxel, irinotecan, leucovorin, oxaliplatin, and fluorouracil. The dosing and schedule are specified but depend on the parent study protocols. This trial includes multiple experimental arms reflecting different treatment combinations or regimens, continuing treatment for eligible patients who showed clinical benefit in the parent studies. During the study, participants are monitored for adverse events up to 90 days after their last dose or if they discontinue treatment. Researchers track serious adverse events, treatment-related discontinuations, and deaths related to adverse events. Participation involves ongoing treatment and safety assessments, with the study lasting until the primary completion date in February 2028. The study does not include healthy volunteers and involves adults aged 18 years and older.

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 efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating the combination of bleximenib, venetoclax VEN, and azacitidine AZA compared to placebo with VEN and AZA in treating adults with newly diagnosed Acute Myeloid Leukemia AML who have mutations in the NPM1 or KMT2A genes. This Phase 3 study focuses on participants who are not eligible for intensive chemotherapy due to age or other health conditions. The goal is to understand how these treatments work in this specific AML population. Participants receive treatment in 28-day cycles, either with bleximenib plus VEN and AZA or placebo plus VEN and AZA. Bleximenib, VEN, and placebo are taken orally, while AZA is given intravenously or under the skin. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for response to treatment including complete remission and overall survival for up to over four years. Researchers will track event-free survival, duration and timing of remission, transfusion independence, and other health outcomes. Safety is also closely observed through adverse events and lab tests. Participation involves regular visits for treatment and assessments over the study period.

This research aims to evaluate LN-145, an autologous tumor-infiltrating lymphocyte TIL therapy, in patients with metastatic non-small-cell lung cancer NSCLC. This phase 2, open-label, multi-cohort, non-randomized study involves patients with metastatic NSCLC, including those with varying PD-L1 tumor expression levels. The study excludes patients with certain genetic mutations and focuses on those with disease progression after prior therapies. The primary purpose is to assess treatment response and safety over time. Participants receive LN-145, which is produced by collecting a tumor sample to expand TILs outside the body. Before the infusion of LN-145, patients undergo a non-myeloablative lymphodepleting chemotherapy regimen including cyclophosphamide and fludarabine. After LN-145 infusion, patients are given IL-2 to support immune response. The study includes several cohorts based on tumor PD-L1 status, prior treatments, and other factors, with specific eligibility and treatment pathways for each. Throughout the study, participants are monitored for objective response rate and other outcomes up to 60 months. Assessments include disease progression evaluation, adverse event tracking, and biopsies. The study spans from screening through treatment and extended follow-up to evaluate long-term effects. Participants must meet performance and organ function criteria and agree to use effective birth control during and after treatment.

Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.

Researchers are evaluating a mobile health m-health solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus T2DM living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record EPR against usual diabetes care, focusing on changes in glycated hemoglobin HbA1c levels over an 18-month period. The study aims to enhance patients abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.

Researchers are evaluating the EuroHeart program, an observational and prospective multicenter initiative designed to improve quality of care for patients with common cardiovascular diseases such as Acute Coronary Syndrome ACS, heart failure, and atrial fibrillation. EuroHeart collects standardized and harmonized patient data to support continuous quality improvement by monitoring adherence to quality indicators defined by the European Society of Cardiology ESC. The program aims to understand how well proven treatments are applied in everyday clinical practice. The study involves continuous data collection from consecutive patients hospitalized or treated for these cardiovascular conditions. Participants enter a 12-month follow-up period during which clinical events and health status data are gathered. This registry specifically evaluates adherence to ESC quality indicators in Italian clinical practice, including measures such as time to reperfusion and prescription of recommended medications at discharge. Participants will be monitored through regular collection of clinical data over the 12 months following enrollment. Researchers will assess adherence to multiple ESC quality indicators related to treatment and management of STEMI and NSTEMI patients, including evaluations of left ventricular function, lipid levels, and use of dual antiplatelet therapy and other medications. The study also tracks cardiovascular and non-cardiovascular events during follow-up to support quality improvement efforts. Participation involves consent and data collection without experimental treatments.

Researchers are studying patients with advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The trial compares two chemotherapy approaches after an initial treatment period continuing the current chemotherapy regimen called mFOLFIRINOX or switching to a different chemotherapy combination of gemcitabine plus nab-paclitaxel. This phase III randomized trial aims to find out which approach helps patients live longer without disease progression after three months of initial chemotherapy. Participants first receive mFOLFIRINOX chemotherapy every two weeks for about 14 weeks, with at least 4 cycles required to continue in the trial. Those whose cancer has not worsened are then randomly assigned to one of two groups. One group continues mFOLFIRINOX, which includes oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil given by infusion every two weeks. The other group switches to gemcitabine and nab-paclitaxel, given on days 1, 8, and 15 in 28-day cycles. Treatment continues until the cancer progresses, side effects become unacceptable, the participant withdraws consent, or death. During the study, participants will have regular scans to monitor their cancer and assessments to track side effects, quality of life, and treatment response. Researchers will measure overall survival up to 48 months after randomization, along with progression-free survival, time until treatment stops, and other health outcomes. The trial includes ongoing evaluations of toxicity and quality of life to understand the impact of each treatment approach on patients. Participants remain under close medical supervision throughout the study period.

Researchers are evaluating the effect of adding gemtuzumab ozogamicin to standard chemotherapy for adults aged 18 to 60 with newly diagnosed favorable or intermediate-risk acute myeloid leukemia AML. This phase 3 study aims to reduce minimal residual disease MRD levels before transplantation and assess whether MRD-driven post-remission therapy can improve anti-leukemic outcomes. The study excludes patients with certain genetic markers or prior treatments to focus on a specific AML subgroup. Participants receive induction treatment with gemtuzumab, daunorubicin, and cytosine arabinoside, followed by consolidation therapy with adjusted doses of these drugs. After consolidation, patients undergo either autologous or allogeneic stem cell transplantation based on their MRD level. This MRD-guided approach helps tailor the intensity of post-remission therapy. Throughout the study, participants undergo MRD assessments to measure treatment activity, with the primary outcome being MRD negativity two months after starting therapy. Researchers also monitor kidney and liver function, heart health, and overall compliance with study procedures. The study involves regular clinical observations and assessments to evaluate the effectiveness of the combined treatment and its impact on MRD levels over time.