University of California Davis Cancer Center

This research aims to gather health information from infants, children, adolescents, and young adults diagnosed with cancer to improve treatment and ongoing care. It maintains a Childhood Cancer Registry and uses clinical and biological data to identify eligibility for Childrens Oncology Group therapeutic trials. The study also develops a biorepository of biospecimens and clinical data for current and future research, including tumor and host DNA samples, and allows for future contact regarding additional research studies. Participants are assigned to one of two observational protocols. In the Project Every Child Protocol, medical data is reviewed to create a cancer registry, and biospecimens such as tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, or urine are collected. In the Project AYA Protocol, biospecimens are collected similarly. These samples are gathered at diagnosis, progression, recurrence, or post-mortem where applicable. During the study, participants undergo medical chart reviews and biospecimen collections. Researchers measure the number of patients consenting to biobanking as a primary outcome. Clinical data including diagnosis, staging, treatment summaries, and outcomes are recorded. The study involves ongoing data collection over time to support future research and screening for trial eligibility, with participation lasting as long as data and samples continue to be collected.

Researchers are developing and testing protocols to improve research involving ethnic and racial minorities with Multiple Myeloma MM using cancer registry data. The study aims to better understand factors related to the causes and survival of MM among different racial and ethnic groups. Initially, a pilot study contacted 400 patients across four groups to assess the feasibility of recruitment and data collection, with plans to expand the research to include over 1,000 participants per group using Californias three cancer registries. The study involves identifying eligible patients diagnosed with MM in California who are at least 21 years old and alive at the time of participation. Researchers will contact participants by mail, sending a survey packet that includes instructions, consent information, the survey itself, and incentives. The survey covers demographics, risk factors, cancer treatment, quality of life, and social determinants of health, taking about 30-45 minutes to complete. This phase will extend through 2025 and may include a survivorship cohort. Participants will be involved by completing mailed surveys and possibly providing saliva samples for additional analysis. Researchers will monitor response rates by raceethnicity and disease status to identify any disparities in participation. Data will be collected and handled following cancer registry policies. The study seeks to inform best practices for recruiting minorities with MM and provide insights for larger population-based studies on MM causes and survival.

Researchers are studying the health of people with Down syndrome who have been treated for acute leukemia. Children with Down syndrome face higher risks of side effects during leukemia treatment, but its unclear how this affects their long-term health. The study aims to understand chronic health conditions and other lasting effects after leukemia treatment in this group to help improve their quality of life and develop better care guidelines. Participants may provide saliva or buccal swab samples, undergo clinical assessments, and, if they have Down syndrome-associated acute lymphoblastic leukemia, may also give blood samples and complete neurocognitive tests. These evaluations are done in parts, including biospecimen collection, clinical evaluation, and neurocognitive assessment. During the study, participants will be assessed for chronic health conditions, neuropsychological outcomes reported by parents, health-related quality of life, and clinical risk factors. Researchers will also create a detailed group of survivors and a biobank for future research. The main outcome measured is the prevalence, type, and severity of chronic health conditions. The study will continue until June 2029, with ongoing assessments and data collection.

Researchers are evaluating the safety, side effects, and best dose of a combination of two anti-cancer drugs, neratinib and trastuzumab deruxtecan, in patients with advanced solid tumors that have spread or cannot be removed by surgery and have changes in the HER2 gene. This phase I trial aims to determine the maximum tolerated dose, assess tumor response, and study the drugs effects on tumor markers and overall survival in this patient population. Participants receive neratinib orally once daily on specified days of each 21-day cycle and trastuzumab deruxtecan intravenously over 30 to 90 minutes on day 1 of each cycle. Treatment cycles repeat every 21 days unless disease progression or unacceptable side effects occur. The study includes dose-escalation and dose-expansion phases, with possible tissue biopsies at various points to evaluate tumor changes and drug impact. Throughout the study, participants undergo blood sample collection, CT scans, and heart function tests via echocardiography or MUGA scans. Biopsies may be performed at baseline, during the study, or at disease progression depending on the cohort. After treatment ends, patients are followed every three months for at least one year to monitor health and survival outcomes. Researchers measure treatment safety, tumor response rates, duration of response, progression-free survival, and drug concentrations over this period.

Researchers are evaluating the combination of azacitidine or decitabine with venetoclax in patients with acute myeloid leukemia AML who have either not been treated before or whose disease has returned. This phase II trial focuses on patients who have previously failed treatment with hypomethylating agents HMA and aims to assess overall response rates, additional measures of effectiveness, and safety of this combination therapy. Participants receive azacitidine intravenously or subcutaneously on days 1 to 7 if they previously used decitabine, or decitabine intravenously on days 1 to 5 if they previously used azacitidine. Venetoclax is taken orally every day for 28 days. These treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects do not occur. During the study, participants undergo evaluations including response assessments up to one year, monitoring of minimal residual disease, rates of remission, transfusion independence, survival measures, and adverse events. Safety and treatment effects are closely monitored throughout the study period to better understand the impact of this combination therapy in AML patients with prior HMA failure.

This research aims to evaluate how well amivantamab given by subcutaneous injection works in treating patients with advanced non-small cell lung cancer that has extra copies of the MET gene. This phase II Expanded Lung-MAP treatment trial focuses on patients with MET amplification-positive non-small cell lung cancer. The goal is to see if amivantamab-SC can reduce tumor growth or spread by targeting the extra MET gene copies in these tumors. Participants receive amivantamab subcutaneously on days 1, 8, 15, and 22 during the first 28-day cycle, then on days 1 and 15 of subsequent 28-day cycles as long as the disease does not progress or unacceptable side effects occur. Throughout the trial, patients have regular CT or MRI scans and blood samples taken to monitor treatment effects and disease status. After completing treatment, patients are followed for up to 3 years to assess long-term outcomes. During the study, researchers evaluate how many patients respond to the treatment, how long responses last, progression-free survival, overall survival, and the frequency and severity of side effects. Blood samples are collected before treatment, during therapy, and at disease progression to study tumor DNA and build a tissue and blood repository. Safety labs, physical exams, and performance status assessments are also conducted. The total participation can last up to 3 years including follow-up.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are studying the safety, side effects, and effectiveness of LOXO-435 alone or combined with standard cancer medicines in participants with advanced solid tumors that have changes in the FGFR3 gene. This includes cancers of the urinary system such as metastatic urothelial cancer. The study is an open-label phase 1 trial conducted in two parts dose escalation and dose expansion, focusing on finding the best dose and evaluating initial antitumor activity. Participants will receive LOXO-435 orally, either alone or with pembrolizumab and enfortumab vedotin administered intravenously, depending on their group. The study includes a dose escalation phase to determine the optimal dose and a dose expansion phase with several cohorts testing different combinations. Treatment continues for up to 30 months or longer if the disease does not worsen. During the study, participants will undergo assessments including safety monitoring, tumor response evaluation, pharmacokinetics testing, and quality of life questionnaires related to bladder symptoms and physical function. Researchers will track side effects and treatment impact over time, with visits scheduled regularly throughout treatment and follow-up. Participation may last up to 2.5 years, with ongoing monitoring of tumor response and safety.

Researchers are studying very low-risk and low-risk fusion negative rhabdomyosarcoma, a type of soft tissue cancer, to maintain excellent treatment outcomes while reducing therapy burdens. This phase III trial also evaluates how well patients with certain DNA mutations respond to different chemotherapy regimens and examines the use of centralized molecular risk stratification in treatment planning. The study aims to improve outcomes by adjusting therapy intensity based on molecular features. Patients are assigned to one of three treatment regimens based on their risk level and mutation status. Very low-risk patients receive vincristine and dactinomycin over 24 weeks in 8 cycles. Low-risk patients receive 12 weeks of vincristine, dactinomycin, and cyclophosphamide followed by 12 weeks of vincristine and dactinomycin, totaling 8 cycles. Patients with MYOD1 or TP53 mutations switch to an intensified 12-13 cycle regimen including vincristine, dactinomycin, and cyclophosphamide. Radiation therapy may be given at cycle 5 for some patients. Treatments are administered intravenously every 21 days. Throughout the study, participants undergo CT scans, MRI, bone scans, PET scans, and tumor biopsies to monitor disease status. Blood and tissue samples are collected at various times for research purposes. Researchers measure failure-free survival and overall survival over several years to assess treatment success. The trial lasts up to five years with ongoing assessments to track patient outcomes and safety.

Researchers are evaluating treatment options for patients newly diagnosed with multiple myeloma who are considered frail or intermediate-fit and who are not candidates for stem cell transplant. This phase III trial compares three different three-drug induction regimens followed by either single or double drug maintenance therapies. The study aims to find which drug combination best controls the cancer and improves patient outcomes while considering patients age, other health conditions, and physical function. Participants are randomly assigned to one of three treatment arms. In Arm 1, patients receive bortezomib, lenalidomide, and dexamethasone with bortezomib given subcutaneously and the others taken orally for up to 9 cycles, followed by lenalidomide maintenance. Arm 2 involves daratumumab with hyaluronidase-fihj given subcutaneously, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. Arm 3 includes the same induction as Arm 2, but maintenance therapy combines daratumumab with hyaluronidase-fihj and lenalidomide. Each cycle lasts 28 days, and treatment continues without disease progression or unacceptable side effects. During the trial, participants undergo regular assessments including tumor measurements, blood tests, and quality-of-life questionnaires. Researchers monitor progression-free survival, overall survival, response rates, minimal residual disease status, and patient-reported symptoms and health status. After completing treatment, patients are followed up every 3 months for one year, every 6 months for two years, and then annually for up to 10 years to monitor long-term outcomes and safety.