Alcoa

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. 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 after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the combination of cabozantinib, nivolumab, and ipilimumab to treat patients with rare genitourinary tumors that have spread from their original location to other parts of the body. This phase II trial aims to measure how effective this combination is by looking at tumor response rates and survival outcomes. The study also assesses safety and supports tissue banking and clinical follow-up to better understand these rare cancers, including specific evaluation for patients with bone-only disease. Participants receive cabozantinib orally once daily during the first four cycles on a 21-day schedule and then continuously on a 28-day schedule for subsequent cycles. Nivolumab and ipilimumab are given intravenously on day 1 of cycles 1 to 4, followed by nivolumab alone on day 1 of later cycles. Treatment continues for up to 2 years unless the disease progresses or side effects become unacceptable. Patients may undergo several imaging tests such as CT, MRI, bone scans, PET/CT, and echocardiography throughout the study. During the trial, patients provide blood and urine samples regularly and undergo imaging to monitor disease status and treatment effects. Researchers track tumor response, progression-free survival, overall survival, and clinical benefit rates. After finishing treatment, participants are followed every two months for up to five years to observe long-term outcomes and safety.

Researchers are evaluating the effect of chemotherapy with capecitabine and temozolomide after surgery in patients with high-risk well-differentiated pancreatic neuroendocrine tumors. This phase II trial aims to see whether giving these chemotherapy drugs after tumor removal can prevent or delay the return of cancer compared to just observation. The study also looks at overall survival, safety, and collects tissue samples for future research. Participants are randomly assigned to one of two groups. One group receives capecitabine orally twice daily on days 1-14 and temozolomide orally once daily on days 10-14, repeated every 28 days for up to four cycles if there is no disease progression or unacceptable side effects. The other group is monitored without active treatment. After treatment or observation, all patients are followed up every six months for three years and then yearly up to five years from randomization. During the study, participants undergo regular scans to check for cancer recurrence and have blood tests to monitor their health and treatment effects. Researchers review medical history, physical exams, and laboratory tests before and during the study. The main outcome measured is recurrence-free survival over five years. Safety and tolerability of the chemotherapy are also tracked throughout the study period.