Walla Walla

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 two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

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 studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors (ICIs). The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are evaluating the use of carboplatin chemotherapy given before surgery in patients with high-risk prostate cancer who have inherited mutations in the BRCA1 or BRCA2 genes. This phase II trial aims to determine how well carboplatin works in shrinking tumors prior to surgery and to assess its impact on disease progression and survival. The study also monitors treatment side effects and collects tissue samples for future research. Participants receive carboplatin intravenously before undergoing prostate surgery. Those who show signs of disease progression after surgery will have imaging tests such as CT, MRI, chest X-ray, or PSMA PET scans. Blood samples are collected throughout the trial to monitor health and support additional studies. The study includes detailed follow-up to evaluate treatment outcomes and safety. During the trial, participants will have regular assessments including physical exams, PSA tests, and imaging scans if needed. Researchers will review the rate of complete tumor response after carboplatin treatment at surgery and track progression-free survival and overall survival over time. Safety and side effects of the treatment are closely monitored. Participation may last up to five years with ongoing collection of health data and specimens.

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 player's 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 user's 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 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.