Wyandotte

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating the safety, side effects, and best dose of the drug cabozantinib combined with standard chemotherapy in treating patients newly diagnosed with osteosarcoma. This study aims to compare the effect of adding cabozantinib to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. Cabozantinib is a kinase inhibitor that may slow tumor growth by blocking signals involved in blood vessel formation and growth pathways. The trial includes both phase II and phase III components and involves patients with localized or metastatic high-grade osteosarcoma, including those with pelvic tumors or unresectable disease. During the feasibility phase, patients received cabozantinib orally and standard chemotherapy intravenously in a series of induction, consolidation, and maintenance cycles over several months. In the efficacy phase, patients are randomized into groups receiving either standard chemotherapy alone or combined with cabozantinib, with treatment cycles lasting 35 days each followed by local control procedures like surgery. The study monitors the impact of adding cabozantinib on event-free survival and overall survival. All participants undergo imaging (X-ray, CT, MRI, PET or bone scan) and blood sample collection at diagnosis and throughout the trial. Participants are closely monitored through scans and blood tests at various time points to assess treatment effects and safety. Researchers measure dose-limiting toxicities during the initial 6 weeks and track event-free survival and overall survival for up to five years after completing treatment. The study also collects tumor tissue and blood samples to study tumor DNA and assess response to therapy. Patient-reported outcomes on therapy-specific side effects and symptom burden are evaluated to understand tolerability. The total participation duration varies based on treatment cycles and long-term follow-up assessments.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab in patients with advanced or locally unresectable stomach or esophageal adenocarcinoma. This phase II/III trial aims to determine if adding nivolumab improves progression-free survival and overall survival compared to paclitaxel and ramucirumab alone. The study also assesses response rates, disease control, safety, tolerability, and quality of life in participants with PD-L1 CPS 21 1 advanced gastric or esophageal cancer. Participants are randomly assigned to one of two treatment groups. The first group receives nivolumab IV on day 1 of each 28-day cycle, ramucirumab IV on days 1 and 15, and paclitaxel IV on days 1, 8, and 15. The second group receives ramucirumab IV on days 1 and 15 and paclitaxel IV on days 1, 8, and 15 of each cycle. Treatment continues every 28 days until disease progression or unacceptable side effects occur. Optional blood samples may be collected during the study. Imaging with CT and MRI is performed throughout. Participants undergo scans and assessments at baseline and during treatment to monitor cancer progression and treatment effects. They also complete questionnaires on quality of life and symptoms. After treatment ends, participants are followed up at 30, 60, and 90 days and then every 6 months for up to 3 years. Researchers measure progression-free survival and overall survival as primary outcomes, along with other safety and patient-reported measures.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating a phase II Lung-MAP treatment trial testing combinations of targeted drugs—capmatinib, osimertinib, and ramucirumab—to treat patients with advanced non-small cell lung cancer (NSCLC) that has spread and shows EGFR and MET gene changes. Capmatinib and osimertinib are kinase inhibitors that block abnormal proteins signaling cancer growth, while ramucirumab is an antibody that may stop new blood vessel growth needed by tumors. Targeting these gene changes may help shrink or control the cancer. Patients are randomized into two groups: one group receives capmatinib and osimertinib orally along with ramucirumab intravenously, while the other group receives capmatinib and osimertinib orally without ramucirumab. Throughout the study, participants undergo CT or MRI scans and provide blood samples. The treatments are given according to the assigned group to compare their effects and safety. During the trial, participants are closely monitored with imaging and blood tests to assess cancer progression and treatment side effects. The main measure is progression-free survival, tracking time until cancer worsens or death, over up to 3 years. Researchers also evaluate response rates, overall survival, toxicity, and collect tissue and blood samples to study tumor DNA. Participants' health status and laboratory values are regularly checked to ensure safety and effectiveness of the treatments.

Researchers are investigating treatments for patients newly diagnosed with AL amyloidosis, a condition involving abnormal protein deposits in organs. This phase III trial compares the effects of adding a stem cell transplant with melphalan chemotherapy after initial treatment with a combination of daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) versus continuing Dara-VCD chemotherapy alone. The goal is to evaluate differences in major organ deterioration progression-free survival, overall survival, organ response, toxicity, and quality of life between the two approaches. Participants first receive induction therapy with Dara-VCD drugs over three 28-day cycles. Those who respond to induction are randomized to one of two consolidation treatments: either continued Dara-VCD chemotherapy or high-dose melphalan chemotherapy followed by autologous stem cell transplant. After consolidation, all participants receive maintenance therapy with daratumumab monthly for up to 18 cycles unless disease progresses or toxicity occurs. The study also collects tissue and blood samples for disease and response assessments. Throughout the study, participants undergo regular examinations including echocardiography, bone marrow biopsies, imaging scans (CT, MRI, or PET-CT), and blood and urine tests. Physical function, fatigue, and patient-reported symptoms are assessed with questionnaires. Follow-up visits occur every 3 to 6 months for up to 4 years after registration. The main outcome measured is the time without major organ deterioration or disease progression, assessed for up to four years from randomization.

Researchers are evaluating the effectiveness of two different monoclonal antibody treatments, rituximab and mosunetuzumab, for patients with follicular lymphoma that has a low tumor burden. This is a phase III trial aiming to compare how well these treatments work in preventing disease progression, transformation to a more aggressive lymphoma, or death. The study also looks at overall survival, response rates, event-free survival, and the frequency and severity of side effects. Specimens will be collected and stored for future research. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive rituximab intravenously on the first day and then rituximab combined with hyaluronidase subcutaneously on several days during a 56-day cycle, repeated for up to five cycles if the disease does not worsen or cause unacceptable side effects. In the second group, patients receive mosunetuzumab subcutaneously on several days during a 21-day cycle, repeated for up to eight cycles under the same conditions. Both groups undergo CT or PET/CT scans and blood sample collection during treatment and follow-up. After completing the treatment cycles, patients are followed every six months for five years and then yearly up to a total of 10 years to monitor their health and disease status. Researchers collect imaging results, blood tests, and other assessments to track progression-free survival, overall survival, treatment response, and safety. The study measures how long participants live without disease progression or transformation and records any treatment-related toxicities throughout the study period.

Researchers are evaluating treatments for patients with metastatic kidney cancer to see if adding surgery to standard immunotherapy-based drug combinations improves outcomes. This phase III trial focuses on kidney cancer that has spread to other parts of the body. The study compares standard immunotherapy drugs, which help the immune system fight cancer, with or without the surgical removal of the kidney, known as nephrectomy. Doctors currently do not agree on whether surgery adds benefit when combined with these immunotherapy treatments. Participants first receive one of three immunotherapy-based drug regimens, including combinations of nivolumab, ipilimumab, pembrolizumab, avelumab, and axitinib, given through intravenous infusions and oral tablets over several weeks. After 10-14 weeks of this initial treatment, patients are randomly assigned to either continue immunotherapy drugs alone or to also have kidney surgery followed by the same drugs. Surgery may be done by different methods and must occur within 8 weeks of randomization. Axitinib is stopped at least 24 hours before surgery. During the study, participants undergo regular scans of the chest, abdomen, and pelvis to assess disease status. They are monitored for survival for up to 7 years after randomization, with follow-up visits every 3 months in the first year, then every 6 months for two years, and annually thereafter. Researchers also evaluate tumor response, surgical complications, and drug side effects. Specimens are collected for future research, and participants' health and treatment effects are closely followed throughout the study period.