Avon

Researchers are evaluating whether adding adjuvant chemotherapy ACT to ovarian function suppression OFS plus endocrine therapy ET improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigators discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients health and quality of life.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. The trial aims to determine if durvalumab can improve disease-free survival and overall outcomes compared to the usual approach of monitoring without additional treatment. This is a phase III randomized trial focusing on patients with stage II-IIIB non-small cell lung cancer who achieved a complete response after neoadjuvant chemo-immunotherapy. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously every 28 days for up to 12 cycles, pending no disease progression or unacceptable side effects. The other group undergoes active surveillance through regular follow-up without additional treatment for 12 months. Both groups have scheduled computed tomography scans and blood sample collections throughout the trial. Patients are followed annually for up to 10 years after treatment completion. During the study, participants undergo various assessments including CT scans, blood tests, and patient-reported quality of life questionnaires. Researchers monitor disease recurrence, new lung cancers, survival, and treatment side effects over a 10-year period. Quality of life and symptom evaluations related to skin and nerve sensations are also compared between the groups. This extensive follow-up helps evaluate the long-term effects and safety of durvalumab versus observation.

Researchers are evaluating the effects of two chemotherapy combinations, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for treating advanced, unresectable, or metastatic HER2 negative cancers of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine if overall survival improves with mFOLFIRINOX compared to mFOLFOX and to assess differences in progression-free survival, response rates, safety, and patient-reported outcomes. Participants are randomly assigned to one of two groups one receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan intravenously, with nivolumab given as needed the other group receives fluorouracil, leucovorin calcium, and oxaliplatin intravenously, also with nivolumab as indicated. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional research on markers like PD-L1 combined positive score and cell-free DNA. During the study, participants will have regular imaging scans and blood collections to monitor their cancer and treatment effects. Researchers will track overall survival for up to two years and monitor progression-free survival, tumor response, duration of response, and adverse events for up to three years. Patient-reported outcomes will be collected at baseline and throughout treatment cycles to assess tolerability and side effects.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

Researchers are evaluating the addition of tivozanib to the immunotherapy drug pembrolizumab compared to pembrolizumab alone for patients with high-risk renal cell carcinoma RCC. This phase III trial aims to assess whether combining these treatments improves disease-free survival and overall survival in patients who have undergone surgery to remove all known kidney cancer sites. The study also looks at side effects, quality of life, fatigue, and collects specimens for future research. Participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days within a 12-week cycle, repeated up to four cycles if no disease progression or unacceptable side effects occur. The other group receives the same pembrolizumab schedule plus oral tivozanib taken daily on specified days within the cycle for up to six months. Both groups have blood samples taken and undergo MRI or CT scans during the trial. Tissue biopsies may also be performed. After the treatment phase, participants are followed with check-ups every four months for two years, then every six months for three years, and then yearly for five more years. Researchers monitor disease recurrence, survival, side effects, treatment tolerance, and patient-reported quality of life and fatigue through questionnaires. This long-term follow-up helps evaluate the lasting effects and safety of the treatments.

Researchers are studying patients who have had surgery to remove the bladder, kidney, ureter, or urethra due to muscle-invasive urothelial cancer. This trial evaluates whether a blood test measuring circulating tumor DNA ctDNA can identify those who need additional immunotherapy to prevent cancer recurrence. The study also compares treatment with nivolumab alone versus nivolumab combined with relatlimab, focusing on survival and disease progression outcomes. Participants are assigned to one of two groups based on their ctDNA blood test results. Those with positive ctDNA are randomized to receive either nivolumab alone or nivolumab plus relatlimab, each given intravenously every 28 days for up to 12 cycles. Participants with negative ctDNA are randomized to receive immediate nivolumab or be monitored closely with ctDNA surveillance and start nivolumab only if their ctDNA becomes positive. Throughout the study, patients undergo tissue and blood collection, imaging scans like CT or MRI, and may have cystoscopy. During the trial, participants are regularly monitored with blood tests for ctDNA, imaging, and questionnaires to assess quality of life and fatigue. The study measures the proportion of patients clearing ctDNA after treatment, overall survival, and disease-free survival for up to 5 years. Safety of the treatments is also assessed. After treatment, follow-up visits occur at specific weeks up to nearly 5 years to continue monitoring health and outcomes.