Great Bend

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Researchers are evaluating the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

Researchers are evaluating treatment options for patients with nasal and paranasal sinus squamous cell carcinoma that can be surgically removed. This phase II randomized trial compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to see if giving chemotherapy first can shrink tumors and help preserve important nearby structures like the skull base and orbit, while also looking at overall survival and progression-free survival. Participants are randomly assigned to one of two groups. One group has surgery followed by radiation therapy, with additional chemotherapy if certain risk factors are found after surgery. The other group receives chemotherapy first, then surgery, followed by radiation therapy with possible additional chemotherapy. Chemotherapy drugs studied include docetaxel, cisplatin, and carboplatin, all given through intravenous infusions. Radiation therapy is delivered using image-guided intensity-modulated radiation therapy IMRT daily for several weeks. During the study, participants undergo scans like MRI and PETCT to assess tumor response and help predict outcomes. They are monitored regularly for side effects and treatment effects, with follow-up visits every three months for up to two years and then every six months up to five years. Researchers also collect data on tobacco use and its impact on treatment outcomes. The main outcomes measured are the rate of preserving the skull base and orbit and overall survival over five years.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the players skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the users performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

Researchers are evaluating different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are not eligible for stem cell transplant and are considered frail or intermediate-fit based on age, other health conditions, and functional status. This phase III trial compares three induction regimens followed by either single or double maintenance therapy to see which combination works best to control the cancer and improve survival. The study also examines patient quality of life, safety, and other treatment effects over time. Patients are randomly assigned to one of three treatment groups. The first group receives bortezomib, lenalidomide, and dexamethasone for up to nine 28-day cycles, followed by lenalidomide maintenance. The second group receives daratumumab and hyaluronidase-fihj, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. The third group has the same induction as the second group but receives both daratumumab and lenalidomide during maintenance. Treatments are given by injection or orally on specific days within each cycle, and continue as long as the disease does not progress or side effects are unacceptable. Participants undergo assessments including tumor measurements, blood tests, patient-reported questionnaires, and blood sample banking for future research. After completing treatment, patients are followed up every three months for one year, then every six months for two years, and annually for up to ten years to monitor progression, survival, and quality of life. The main outcomes measured are progression-free survival and overall survival, with additional evaluations of response rates, safety, and symptom reports up to ten years after starting the study.

Researchers are comparing two treatment approaches for patients with stage II to IIIB non-small cell lung cancer NSCLC that can be surgically removed. The study evaluates whether giving standard therapy both before and after surgery perioperative is more effective than giving it only after surgery adjuvant. The trial is phase III and aims to understand which approach leads to better survival and fewer complications in patients with resectable lung cancer. Participants are randomly assigned to one of two treatment groups. In the first group, patients have surgery within 28 days of joining the study, followed by up to four cycles of platinum-based chemotherapy and up to one year of immunotherapy if the cancer does not progress or cause unacceptable side effects. In the second group, patients receive chemotherapy combined with immunotherapy before surgery, then undergo surgery, and continue immunotherapy after surgery for up to one year under similar conditions. Throughout the study, patients may have CT scans, and possibly MRI or PETCT scans at the start. During the trial, researchers will monitor patients closely over time, including follow-up visits every six months for up to 10 years after treatment ends. They will assess outcomes such as survival without events like cancer recurrence or progression, overall survival, rates of surgery and complete tumor removal, side effects leading to treatment stops or hospitalizations, and the bodys response to treatment. This comprehensive monitoring helps evaluate the benefits and risks of each treatment approach.

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.