Alcoa

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are evaluating the effectiveness of combining cabozantinib with two immunotherapy drugs, nivolumab and ipilimumab, in treating patients with rare genitourinary tumors that have spread beyond their original site. This phase II study focuses on patients with various rare histological types of genitourinary cancers, aiming to assess how well this combination works compared to using each drug alone. The trial also aims to understand the safety of this treatment and to collect tissue samples and clinical data for further research. Participants receive cabozantinib orally once daily on days 1-21 of the first four cycles and continuously on days 1-28 of subsequent cycles. Nivolumab and ipilimumab are given intravenously on day 1 of the first four cycles, with nivolumab continuing as an IV infusion on day 1 of later cycles. Each treatment cycle lasts 21 days initially and 28 days thereafter, continuing for up to two years unless the disease progresses or unacceptable side effects occur. Patients may have scans such as CT, MRI, bone scans, and PETCT during the study and undergo blood and urine sample collections. Echocardiography is performed during screening. Throughout the study, participants are monitored with imaging tests and sample collections to track tumor response and safety. After completing treatment, patients have follow-up visits every two months for up to five years to observe long-term effects and survival. The main measure of success is the objective response rate, with additional assessments of progression-free survival, overall survival, clinical benefit, and adverse events. This extended monitoring helps researchers understand the lasting impact of the treatment combination.

Researchers are evaluating the effect of chemotherapy drugs capecitabine and temozolomide after surgery in patients with high-risk well-differentiated pancreatic neuroendocrine tumors. This phase II trial compares treatment with these drugs to observation only, aiming to see if chemotherapy can prevent or delay cancer recurrence and improve survival. The study also assesses the safety and tolerability of this chemotherapy combination and collects specimens for future research. Participants are randomly assigned to one of two groups. In the first group, patients take capecitabine twice daily on days 1 to 14 and temozolomide once daily on days 10 to 14, repeating this 28-day cycle for up to 4 cycles if there is no disease progression or unacceptable side effects. The second group undergoes surveillance without active treatment. After treatment or observation, all patients are followed every 6 months for 3 years, then annually until 5 years from randomization. During the study, participants will have regular medical exams and scans to monitor for cancer recurrence or progression. Researchers will assess recurrence-free survival as the primary outcome over up to 5 years, with overall survival and side effects also tracked. Safety evaluations are done up to 30 days after treatment completion. This long-term follow-up helps understand how well patients do after surgery with or without chemotherapy.