Avon

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to the usual approach of patient observation after surgery in people with early-stage non-small cell lung cancer (NSCLC) who have no remaining cancer cells following standard treatment. This phase III trial aims to determine if durvalumab can improve disease-free survival and overall survival, as well as assess its safety and impact on quality of life. The study focuses on participants with stage II to IIIB NSCLC who achieved a complete response after neoadjuvant chemo-immunotherapy and surgery. Participants are randomly assigned to one of two groups: one group receives durvalumab intravenously every 28 days for up to 12 cycles if there is no disease progression or unacceptable side effects, while the other group undergoes active surveillance without additional treatment for 12 months. Both groups have regular computed tomography (CT) scans and blood sample collections during the study. After treatment or surveillance, participants are followed annually for up to 10 years. Throughout the study, participants complete questionnaires about their quality of life and report symptoms such as rash or numbness. Researchers monitor disease recurrence, new lung cancers, or death, as well as treatment side effects. Specimens and images are collected for future research. The total participation time includes treatment or observation plus long-term follow-up visits to assess the effects and safety of durvalumab compared to observation alone.

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 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 the addition of tivozanib to standard pembrolizumab immunotherapy in treating patients with high-risk renal cell carcinoma (RCC) after surgery. This phase III trial aims to compare disease-free survival between patients receiving pembrolizumab alone and those receiving both pembrolizumab and tivozanib. The study also examines overall survival, side effects, quality of life, and collects specimens for future research. Participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days in a 12-week cycle for up to four cycles. The other group receives the same pembrolizumab schedule plus oral tivozanib on set days within each cycle for up to six months. Both groups undergo blood sample collection, MRI or CT scans, and may have tissue biopsies during the trial. After completing treatment, patients are followed regularly for up to 10 years to monitor disease status and survival. Assessments include imaging scans, laboratory tests, and questionnaires about quality of life and fatigue. Researchers track any side effects and disease recurrence, aiming to understand the long-term benefits and safety of the combined therapy compared to pembrolizumab alone.

Researchers are evaluating patients who have had surgical removal of bladder, kidney, ureter, or urethra due to muscle-invasive urothelial cancer. This phase II/III trial studies whether a blood test measuring circulating tumor DNA (ctDNA) can identify patients at higher risk of cancer returning, and whether immunotherapy treatments including nivolumab and relatlimab can help prevent recurrence and prolong survival. The study aims to determine if ctDNA levels after surgery can guide the need for additional immunotherapy treatment and compare outcomes between different treatment approaches. Patients are assigned to one of two groups based on their ctDNA test results after surgery. Those with positive ctDNA (Cohort A) are randomly assigned to receive either nivolumab alone or nivolumab combined with relatlimab via intravenous infusion every 28 days for up to 12 cycles. Patients with negative ctDNA (Cohort B) are randomly assigned to receive either immediate nivolumab treatment or ctDNA surveillance with treatment starting only if ctDNA becomes positive. Throughout the study, participants undergo tissue and blood sample collections, imaging scans such as CT or MRI, and may have cystoscopy procedures. Participants are closely monitored during treatment and after completing therapy with follow-up visits scheduled at multiple time points up to 248 weeks. Researchers assess the clearance of ctDNA, overall survival, disease-free survival, and quality of life using questionnaires. Safety is also evaluated, and the study explores associations between ctDNA changes and patient outcomes. This comprehensive monitoring helps to understand the benefits and risks of the immunotherapy treatments and the role of ctDNA in guiding therapy for urothelial cancer patients.