San Luis Obispo

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the safety and effectiveness of ibrutinib combined with venetoclax (I+V) and ibrutinib alone in people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 2 study focuses on adjusting the ibrutinib dose either proactively or reactively based on side effects to find the best treatment approach. Participants will receive oral capsules of ibrutinib and, for some groups, oral tablets of venetoclax. The study includes different treatment groups to compare how these regimens work when ibrutinib dosing is modified in response to adverse events. Dosing schedules and adjustments will be closely monitored throughout the study. During the study, participants will undergo regular assessments including scans to measure lymph node size and other tests to track response and safety. Researchers will measure the best overall response rate for up to five years. Safety monitoring and follow-up will continue as needed to evaluate long-term outcomes and treatment tolerability.

Researchers are evaluating the effectiveness of active surveillance and chemotherapy treatments in pediatric, adolescent, and adult patients with low risk and standard risk germ cell tumors. This phase III trial focuses on monitoring patients after tumor removal and comparing the outcomes of carboplatin-based versus cisplatin-based chemotherapy regimens. The study aims to maintain high overall survival rates for low risk patients and to compare event-free survival between the two chemotherapy options in standard risk patients. Additional objectives include assessing side effects such as hearing loss and neuropathy, and exploring tumor marker changes and other biological measures related to treatment outcomes. Patients with low risk stage I germ cell tumors undergo surgery followed by observation, with the option to transfer to standard risk treatment if the tumor recurs. Those with standard risk tumors are randomly assigned to one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin. Treatments are given intravenously on specific schedules every 21 days for up to 3 or 4 cycles, depending on the group. Throughout the trial, patients receive imaging scans, blood tests, tumor biopsies if needed, and pulmonary function tests to monitor treatment response and side effects. Participants are closely followed after treatment completion with regular visits every 2 months for the first year, then less frequently up to 10 years. Researchers collect data through imaging, blood samples, lung tests, and questionnaires to measure survival, disease recurrence, and side effects like hearing loss. The study also includes exploratory analyses of tumor markers and patient-reported outcomes to better understand treatment impacts and improve future care for germ cell tumor patients.

Regular exercise, such as walking 150 minutes per week, offers many health benefits but many adults find it hard to stick with an exercise program. This research focuses on sedentary adults aged 18 to 40 who exercise less than 1 hour per week. The study aims to explore whether offering different types of exercise can help improve how well people stick to their program over time. Participants will be assigned to one of three exercise plans, each requiring 150 minutes per week of moderate to vigorous activity. One group will do walking only. Another group will do a variety of exercises including cycling, walking/jogging, yoga/Pilates, or cross-training, with activities assigned randomly each week. The third group will also do a variety of exercises but can choose which ones to do and how much each week. Throughout the 4-week study, researchers will monitor how closely participants follow their exercise program by measuring changes in adherence weekly. Participants may be asked to complete questionnaires about their health and fitness history to ensure safety. The study will help understand if varying exercise types affects commitment to regular physical activity in sedentary adults.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating how well carboplatin chemotherapy works before surgery in men with high-risk prostate cancer who have inherited mutations in the BRCA1 or BRCA2 genes. This phase II trial aims to see if carboplatin can shrink tumors and lead to complete removal of cancer cells at the time of prostatectomy. The study also monitors progression-free survival, metastasis-free survival, overall survival, and treatment side effects. Additionally, specimens are collected for future research. Participants receive carboplatin intravenously before undergoing prostate surgery. If prostate-specific antigen (PSA) levels rise after surgery, patients undergo imaging tests such as CT, MRI, chest X-ray, or PSMA PET scans to monitor for cancer spread. Blood samples are collected throughout the trial to support further study and evaluation. During the study, participants have physical exams, medical history assessments, and laboratory tests including blood counts and liver and kidney function within 28 days before enrollment. Researchers track PSA progression and survival outcomes for up to five years after treatment. The trial includes regular imaging and safety monitoring to assess treatment effects and disease status over time.

Researchers are evaluating the safety and effectiveness of the coflex4 Interlaminar Technology compared to decompression surgery alone in adults with degenerative spinal stenosis and associated low back pain. This study is a prospective, multi-center trial with concurrent enrollment and a propensity score control, designed to fully characterize clinical outcomes under actual conditions of use, with follow-up evaluations at 2 and 5 years. Participants receive either decompression surgery plus the coflex4 device or decompression surgery alone. The study compares the performance of the coflex device to prior investigational device exemption (IDE) data at 24 and 60 months and to decompression alone from the ESCADA study at 24 months. The treatment focuses on surgical decompression of one or two lumbar levels (L1-L5) with or without additional stabilization using the coflex technology. During the study, participants undergo clinical assessments including pain and disability questionnaires, with measurements such as the Visual Analog Scale for back pain and the Oswestry Low Back Pain Disability Questionnaire. Researchers monitor clinical success and safety outcomes over the extended follow-up period. Participants must comply with scheduled visits and study procedures throughout the duration, including informed consent and psychosocial, mental, and physical ability to adhere to the protocol.

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.