McFarland Clinic - Trinity Cancer Center

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are studying adolescent and young adult AYA cancer survivors who had Hodgkin or non-Hodgkin lymphoma to understand how social and genetic factors affect their health outcomes after treatment. These survivors face unique biological, clinical, psychological, and social challenges that may influence their risks for illness and early death compared to older or childhood cancer patients. The study aims to identify conditions increasing these risks and to better meet the needs of AYA cancer survivors. Participants will complete questionnaires about their quality of life and provide blood samples at the start of the study and again at 6, 12, 18, and 24 months. This observational study collects health and treatment information without administering any medical treatments. The study assesses social-environmental risks, individual resilience factors, and gene expression changes to understand their impact on survival and quality of life. Participants will be asked to fill out health-related questionnaires and provide blood samples multiple times over two years. Researchers will measure disease-free survival, overall survival, comorbidities, and quality of life during this period. The study involves ongoing monitoring through questionnaires and blood tests to gather detailed data on how social and genetic factors influence long-term outcomes for AYA lymphoma survivors.

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.

This trial studies patients with relapsed or refractory T-cell acute lymphoblastic leukemia T-ALL or T-cell lymphoblastic lymphoma T-LBL. It evaluates the safety, side effects, best dose, and effectiveness of OBI-3424, a chemotherapy drug designed to stop cancer cell growth by killing cells or preventing their division or spread. The study also explores how OBI-3424 affects disease remission and survival outcomes. Patients receive OBI-3424 intravenously over 30 minutes on days 1 and 8 of each 21-day cycle. Treatment can continue for up to 17 cycles if the disease does not progress and side effects remain acceptable. Those who do not show partial remission by the fourth cycle may be removed unless the investigator finds them clinically benefiting. The study includes blood tests, cerebrospinal fluid collection, bone marrow biopsy, and possible CT scans throughout treatment. Participants undergo screening with blood tests and provide samples during treatment. They are monitored regularly with bone marrow samples and imaging to assess disease status and treatment response. Follow-up visits occur monthly for one year, then every two months for another year, every three months for a third year, and every six months for up to five years from registration. Researchers measure the maximum tolerated dose, response rates, side effects, survival, and minimal residual disease among other outcomes.

This trial investigates the addition of panitumumab to standard chemotherapy for patients with KRAS wild type pancreatic ductal adenocarcinoma that cannot be removed by surgery or has spread locally or to other parts of the body. The study aims to compare overall survival and other clinical outcomes between patients receiving panitumumab plus chemotherapy and those receiving chemotherapy alone. It also evaluates quality of life, treatment toxicity, and patient-reported symptoms. Participants are randomly assigned to one of two groups. One group receives panitumumab intravenously on days 1 and 15, combined with one of several chemotherapy regimens given intravenously in 28-day cycles, repeating if tolerated without disease progression. The other group receives the same chemotherapy regimens without panitumumab, also in 28-day cycles. Throughout the study, patients undergo CT scans and blood sample collection. After treatment, they are followed for up to three years. During the study, participants will have regular imaging and blood tests to monitor disease status and treatment effects. Quality of life and symptom questionnaires are completed at specified intervals. Researchers measure overall survival, progression-free survival, response rates, duration of response, and treatment side effects. Safety is monitored up to 30 days after treatment ends. Specimens are banked for future research, and patient-reported outcomes help assess the impact of treatment over 24 weeks.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the effect of adding the drug tivozanib to the immunotherapy pembrolizumab compared to pembrolizumab alone in patients with high-risk renal cell carcinoma RCC. The study aims to determine whether this combination improves disease-free survival and overall survival. This phase III trial also assesses side effects, quality of life, and collects specimens for future research in patients who have undergone surgery to remove all known kidney cancer sites. In this study, participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days of each 12-week cycle for up to 4 cycles. The other group receives the same pembrolizumab schedule combined with oral tivozanib taken daily on specific days within the 12-week cycle for up to 6 months. Throughout the trial, participants undergo blood samples, MRI or CT scans, and may have tissue biopsies. After treatment, patients are followed regularly for up to 10 years to monitor outcomes. Participants will have scheduled visits during treatment cycles and follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years. The research team measures disease recurrence or death disease-free survival as the main outcome, along with overall survival, side effects, treatment tolerance, and quality of life. Safety monitoring and quality of life assessments are included to evaluate the impact of the treatments over the long term.

Researchers are evaluating biomarker tests on tumor tissue to select personalized maintenance treatments for patients with extensive stage small cell lung cancer ES-SCLC. This phase II trial aims to determine how well these tests identify cancer subtypes and guide targeted therapies. The study also compares different maintenance treatments, including durvalumab, saruparib, ceralasertib, and monalizumab, which may affect tumor growth and immune response. Participants receive induction treatment with a platinum compound, etoposide, and durvalumab every 28 days for 4 to 6 cycles. After possible thoracic radiation, they are assigned to one of three cohorts based on cancer subtype and SLFN11 status. Each cohort is randomized to receive durvalumab alone or combined with another drug saruparib for cohort A, ceralasertib for cohort B, or monalizumab for cohort C. Maintenance cycles repeat every 28 days if disease does not progress or toxicity occurs. During the study, participants undergo imaging tests such as CT, PETCT, or MRI scans, and tissue and blood samples are collected for analysis. Researchers monitor progression-free survival and overall survival, as well as treatment safety and side effects, for up to three years. After completing study treatment, patients are followed for up to three years to assess long-term outcomes and collect specimens for future research.

Researchers are comparing two treatment approaches for patients with high anatomic stage estrogen receptor-positive, HER2-negative breast cancer who have a low risk of the cancer returning. The trial evaluates whether hormone therapy combined with the drug ribociclib works as well as chemotherapy followed by the same hormone therapy with ribociclib. Ribociclib targets enzymes needed for tumor cell growth, and hormone therapy lowers estrogen levels to help stop tumor growth. Chemotherapy works by killing or stopping the division and spread of cancer cells. Participants are first tested with the Oncotype DX assay to assess recurrence risk only those with scores between 0 and 25 continue. They are then randomly assigned to one of two groups one receives standard chemotherapy followed by hormone therapy plus ribociclib, and the other receives hormone therapy plus ribociclib without chemotherapy. Hormone therapy using letrozole, anastrozole, or exemestane is taken daily in 28-day cycles for at least five years, while ribociclib is taken daily for 21 days each cycle for up to three years. Patients undergo scans such as CT, bone scans, or PET-CT and may give blood samples during the study. Participants are followed closely with visits every 3 months during the first year, every 6 months for years 1 to 5, and annually for years 5 to 10. Researchers will assess invasive breast cancer-free survival up to 10 years and compare disease-free survival, recurrence rates, overall survival, and side effects between the two treatment groups. The study also aims to build a biorepository of tumor and blood samples for future research. This trial lasts until 2029, with ongoing monitoring to understand long-term outcomes and safety.