MyMichigan Medical Center Saginaw

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 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 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.

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 investigating targeted therapies directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread or progressed after standard treatments. This Phase 2 screening trial, called ComboMATCH, aims to match patients to specific combination treatments based on genetic mutations found in their tumor cells. The study seeks to improve treatment planning by using genetic information to guide therapy choices. Patients undergo tumor genetic screening using previously collected samples or a new biopsy if eligible and aged 18 or older. Based on their tumors genetic profile, patients are assigned to one of multiple treatment subprotocols involving different drug combinations. Treatments include oral, intravenous, and intramuscular drugs such as selumetinib, olaparib, fulvestrant, binimetinib, and others. Treatment cycles generally repeat every 28 days until disease progression or unacceptable toxicity. Patients may also undergo biopsies, blood collection, imaging scans CT, MRI, PET, echocardiograms, and bone marrow procedures as part of the study. Throughout the trial, participants have regular assessments including tumor biopsies, blood draws, imaging tests, and heart function monitoring. These evaluations occur during screening, treatment, and follow-up periods. Researchers measure patient enrollment, assignment to treatment arms, and treatment outcomes over up to 8 years. Safety is monitored via clinical evaluations and diagnostic tests. This comprehensive approach aims to evaluate responses to targeted therapies guided by tumor genetics for advanced solid tumors.

Researchers are evaluating dose-escalated radiation therapy compared to usual care for patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have already completed 4 to 6 months of chemotherapy. The study is a phase III trial aiming to determine if higher doses of radiation can improve 3-year overall survival, as well as assess effects on tumor progression, chemotherapy-free intervals, treatment toxicity, and quality of life. This trial is led by NRG Oncology and focuses on patients without disease progression after initial chemotherapy. Participants are randomly assigned to one of two groups. The first group receives standard care, which may include additional chemotherapy options such as FOLFIRINOX, NALIRIFOX, or gemcitabinenab-paclitaxel, standard radiation therapy with concurrent chemotherapy, or observation. The second group receives dose-escalated radiation therapy delivered in either 5 or 25 fractions, with or without concurrent chemotherapy for the 25-fraction option. After radiation, patients who have not completed 6 months of chemotherapy are encouraged to finish it, with treatment beyond 6 months at the physicians discretion. Imaging and tissue biopsies are performed throughout the study. Participants undergo various assessments including blood sample collection, CT scans, MRI, and optional PETCT scans before and during treatment. Tumor tissue biopsies are also collected. Follow-up visits occur every 3 months for the first 2 years and annually for an additional 3 years. Researchers measure overall survival, local disease progression, progression-free survival, chemotherapy-free intervals, and adverse events. Quality of life is evaluated using specific questionnaires over the course of participation.

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 durvalumab, an immunotherapy drug, to chemotherapy before surgery in patients with high-grade upper urinary tract urothelial cancer. This phase IIIII clinical trial aims to compare outcomes between patients receiving chemotherapy alone and those receiving chemotherapy combined with durvalumab. The study focuses on improving event-free survival and pathologic complete response rates before surgery. Participants are assigned to one of three groups based on eligibility for cisplatin chemotherapy. Cisplatin-eligible patients are randomized to receive either durvalumab with accelerated methotrexate, vinblastine, doxorubicin, and cisplatin aMVAC chemotherapy, or aMVAC chemotherapy alone. Cisplatin-ineligible patients receive durvalumab combined with gemcitabine. Treatments are given intravenously in cycles every 14 or 21 days for up to four cycles. Surgery is scheduled within 21 to 60 days following treatment completion for patients without metastatic or unresectable disease. During the study, participants undergo tissue biopsies, blood sample collection, and imaging scans such as CT or MRI to monitor their cancer. After treatment and surgery, follow-up visits occur within 30 days and then every 3 to 6 months for up to five years. Researchers measure event-free survival, pathologic complete response, overall survival, disease-free survival, cancer-specific survival, kidney function, and safety outcomes throughout the trial.

Researchers are evaluating the effects of taking olaparib for one year compared to two years, with or without the addition of bevacizumab, in patients with stage III or IV ovarian cancer that has specific genetic mutations BRCA 12 or a deficiency in homologous recombination. This phase III trial aims to determine if shorter treatment with olaparib is not worse than longer treatment and to study survival, disease progression, toxicity, and other outcomes. The study also explores genetic markers that might predict treatment response. Participants are randomly assigned to one of two groups. In the first group, patients take olaparib orally twice daily for up to two years and may receive bevacizumab intravenously every 21 days for up to one year. In the second group, patients receive olaparib twice daily for up to one year and may also receive bevacizumab on the same schedule. Both groups undergo blood sample collection and imaging scans such as CT or MRI during the study treatment period. After finishing treatment, participants are followed up every three months for two years and then every six months for another three years to monitor health and disease status. Researchers assess progression-free survival based on tumor scans and survival over up to five years. Side effects, including risks of certain blood disorders and secondary cancers, are tracked. The total participation duration may extend over several years, including treatment and long-term follow-up.

Researchers are comparing two types of radiation therapy, fractionated stereotactic radiosurgery FSRS and the usual stereotactic radiosurgery SRS, in treating patients whose cancer has spread to the brain from other parts of the body. This phase III study aims to see if FSRS, which delivers radiation over three sessions, improves the time before the tumor returns compared to SRS, which delivers a single high-dose radiation treatment. The study also looks at other outcomes such as overall survival, brain progression, and side effects of the treatments. Participants are randomly assigned to one of two groups. One group receives a single session of SRS lasting 30 to 90 minutes, while the other group receives FSRS divided into three sessions of the same length. Both groups undergo computed tomography CT and magnetic resonance imaging MRI scans during the study. After treatment, patients are followed closely with regular check-ups every three months for the first year, then every four months for the second year, and every six months for the following three years. During the study, participants will have imaging scans to monitor tumor response and progression. Researchers will measure how long it takes for the tumor to grow back, progression of cancer in the brain, overall survival, and any radiation-related side effects. Safety is monitored for up to two years, and tumor outcomes are tracked for up to five years. This thorough follow-up helps to understand the long-term effects of the two radiation methods in patients with brain metastases.