Adrian

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

Researchers are evaluating the use of osimertinib alone versus a combination of osimertinib and bevacizumab for treating advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial focuses on whether adding bevacizumab, which blocks blood vessel growth to tumors, can better control cancer and improve survival compared to osimertinib alone, a drug that blocks EGFR involved in cancer cell growth. Patients are randomly assigned to receive either osimertinib by mouth once daily or osimertinib with bevacizumab given intravenously every 21 days. Treatment continues unless the cancer progresses or side effects become unacceptable. The study includes imaging tests like CT, MRI, echocardiography, and MUGA scans to monitor disease and heart function, along with blood and urine sample collection. Participants are followed for up to 10 years after treatment ends, with check-ups every 3 months to measure progression-free survival, overall survival, response rates, and side effects. Researchers also analyze blood samples to study how the cancer develops resistance to treatment. This thorough monitoring helps understand long-term effects and how well the treatments control the cancer.

This phase II clinical trial investigates how well the combination of ramucirumab with paclitaxel compares to the FOLFIRI chemotherapy regimen in treating patients with advanced or treatment-resistant small bowel adenocarcinoma. Ramucirumab is a monoclonal antibody designed to block VEGFR-2, potentially limiting blood vessel growth to tumors and slowing cancer spread. Chemotherapy drugs such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan work by killing tumor cells or stopping their growth and spread, aiming to improve survival in this patient population. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive ramucirumab intravenously on days 1 and 15, combined with paclitaxel given intravenously on days 1, 8, and 15 in 28-day treatment cycles. The second group receives the FOLFIRI regimen, which includes irinotecan and leucovorin intravenously on days 1 and 15, plus fluorouracil given as a bolus and continuous infusion over days 1-3 and 15-17, also in 28-day cycles. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients undergo regular assessments including tumor scans and blood tests to track cancer progression and response. Follow-up visits occur every 8 weeks during treatment and then every 6 months for up to three years after disease progression. Researchers measure progression-free survival, overall survival, tumor response rate, and treatment safety. They also collect tissue and blood samples for future research. The study aims to identify which treatment offers better control of cancer growth and improved patient outcomes.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works for patients with hormone receptor positive, HER2 negative metastatic breast cancer. The study compares STMDDM with the usual care approach to see if overall survival is not worse using STMDDM. The trial also looks at healthcare costs, patient anxiety, quality of life, and preferences related to disease monitoring. Patients are randomly assigned to one of two groups. One group receives usual care with imaging at least every 12 weeks and other monitoring at the doctor's discretion for up to 312 weeks if the disease does not progress. The other group has their serum tumor markers checked every 4 to 8 weeks, with imaging only if markers are elevated, also for up to 312 weeks without progression. Additional assessments include quality-of-life and anxiety questionnaires. Throughout the study, participants undergo regular evaluations including imaging, blood tests for tumor markers, and patient-reported outcome questionnaires. Researchers track overall survival up to 312 weeks after randomization, along with healthcare costs and patient experiences. Participants must provide informed consent and are monitored for safety during the study period.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

Researchers are evaluating whether starting treatment early with venetoclax and obinutuzumab improves overall survival compared to delayed treatment in patients newly diagnosed with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase III trial focuses on patients who have asymptomatic disease but high-risk factors such as a high CLL-International Prognostic Index score or complex cytogenetics. Venetoclax is a drug that blocks a protein needed for cancer cell survival, while obinutuzumab is an immunotherapy that may help the immune system attack cancer cells and prevent tumor growth. Participants are randomly assigned to one of two groups: early treatment or delayed treatment. Both groups receive obinutuzumab intravenously on specific days in cycles and venetoclax orally daily during treatment cycles, with each cycle lasting 28 days for up to 12 cycles unless the disease progresses or unacceptable side effects occur. The early treatment group starts therapy as soon as they meet eligibility, while the delayed group begins once standard criteria for active treatment are met. Throughout the study, participants undergo procedures including CT scans, blood sample collection, and bone marrow aspiration and biopsy. During the study, participants are monitored closely through various tests and questionnaires to assess overall survival, quality of life using the FACT-Leukemia scale, response to treatment, and disease progression. The trial also studies measurable residual disease and various biomarkers to understand treatment impact. After treatment, participants are followed for up to 10 years to observe long-term outcomes and safety.

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 safety, side effects, best dose, and effectiveness of adding lenalidomide to nivolumab and the usual drugs rituximab and methotrexate in patients with primary central nervous system (CNS) lymphoma. This phase I trial aims to better understand how lenalidomide, which may slow tumor growth by blocking blood vessel formation, and nivolumab, an immunotherapy that may help the immune system attack cancer cells, work together in treating this type of lymphoma. The study also explores whether prolonged use of these drugs as maintenance therapy after initial chemotherapy can extend control of CNS lymphoma. During the induction phase, patients receive rituximab intravenously on day 1, methotrexate intravenously or orally on day 2, lenalidomide orally daily from days 5 to 9, and nivolumab intravenously on day 14. This cycle repeats every 14 days for up to 6 cycles if there is no disease progression or unacceptable side effects. Patients who respond or have stable disease move on to maintenance therapy, starting within 6 weeks after induction. Maintenance includes lenalidomide taken orally daily on days 1 to 21 and nivolumab given intravenously on day 1, repeated every 28 days for up to 12 cycles. Participants undergo several assessments including MRI scans throughout the trial, CT and PET/CT scans during screening, and lumbar punctures after the 6th induction cycle and 6 months into maintenance. Additional tests like bone marrow biopsy, testicular ultrasound, and echocardiogram may be done during screening. After completing treatment, patients are followed up every 3 months for 2 years, then every 6 months for up to 2 more years. Researchers measure the maximum tolerated dose of lenalidomide during the first treatment cycle and track how many patients can stay on maintenance therapy for 6 months.