Siteman Cancer Center-West County

Researchers are evaluating the effects of pembrolizumab alone compared to the standard treatment of chemotherapy cisplatin or carboplatin combined with radiation therapy after surgery in patients with recurrent or second primary head and neck squamous cell carcinoma. This phase II trial aims to assess overall survival, disease control, metastasis rates, and side effects in high-risk patients, while also exploring whether high PD-L1 expression predicts better responses to pembrolizumab. Participants are randomly assigned to one of two treatment groups. One group receives intravenous cisplatin or carboplatin weekly for six cycles alongside daily intensity-modulated radiation therapy or proton beam radiation totaling 30 sessions. The other group receives intravenous pembrolizumab every six weeks for up to nine cycles. Throughout treatment, participants undergo CT or MRI scans to monitor their condition. After completing treatment, participants are followed up 30 days later and then every six months for up to five years. During the study, researchers evaluate overall survival from randomization to death, adverse events for up to five years, disease-free survival, and PD-L1 expression levels. The study monitors patients closely with imaging and clinical assessments to track treatment effects and safety over time.

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 treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.

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 whether adding chemotherapy before surgery can improve outcomes for patients with high-risk dedifferentiated liposarcoma DDLPS and leiomyosarcoma LMS in the retroperitoneal area. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to improve disease-free survival for these patients. The study is randomized and open-label, involving multiple centers. Participants are randomly assigned to one of two groups. The standard group undergoes large curative surgery within four weeks after randomization. The experimental group receives three cycles of chemotherapy tailored to their sarcoma typedoxorubicin and ifosfamide for high-grade liposarcoma, or doxorubicin and dacarbazine for leiomyosarcomastarting within two weeks of randomization, followed by a reassessment and surgery within three to six weeks after the last chemotherapy cycle. During the study, patients are closely monitored through imaging and pathology reviews to confirm tumor characteristics and treatment effects. Researchers measure disease-free survival over seven years, along with overall survival, recurrence rates, response to chemotherapy, side effects, complications, and quality of life for up to eight years. Participants provide tumor tissue and blood samples for research, and their health and safety are carefully tracked throughout the study period.

Researchers are evaluating the safety, side effects, best dose, and effectiveness of adding lenalidomide and nivolumab to the usual treatment of rituximab and methotrexate in patients with primary central nervous system CNS lymphoma. Lenalidomide may slow or stop tumor growth by blocking blood vessel development, while nivolumab and rituximab are monoclonal antibodies that help the immune system attack cancer cells. This phase I trial aims to improve understanding of these drugs in CNS lymphoma treatment and explore whether maintenance therapy can extend disease control after initial chemotherapy. During the induction phase, patients receive rituximab intravenously on day 1, methotrexate intravenously or orally on day 2, lenalidomide orally daily on days 5 to 9, and nivolumab intravenously on day 14. This 14-day cycle repeats for up to six cycles if the disease does not progress or side effects are unacceptable. Patients with a response or stable disease then enter maintenance therapy, receiving lenalidomide orally daily on days 1 to 21 and nivolumab intravenously on day 1 every 28 days for up to 12 cycles. Various imaging scans and procedures are performed throughout the study for monitoring. Participants undergo MRI scans regularly, CT and PETCT scans during screening, lumbar punctures after induction and maintenance phases, and other tests like bone marrow biopsy and echocardiograms. After completing treatment, patients are followed up every three months for two years, then every six months for an additional two years. Researchers measure outcomes including maximum tolerated dose, treatment response rates, progression-free survival, overall survival, and safety over up to five years.

Researchers are evaluating a phase II trial to study the use of personalized antibody-drug conjugates ADCs for treating patients with advanced or metastatic solid tumors that show high protein expression of Trop-2, nectin-4, or HER2. This trial aims to assess whether targeted treatments with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan work based on RNA and protein testing of tumor markers. These ADCs combine monoclonal antibodies with active drugs to target cancer cells more precisely. The study includes a two-step screening process. First, patients existing RNA test results are reviewed for expression of targets of interest TOIs. Then, protein expression is confirmed by immunohistochemistry IHC on previously collected tissue. Patients with high expression are assigned to one of three treatment cohorts receiving the corresponding ADC drug intravenously on specific schedules sacituzumab govitecan on days 1 and 8 every 21 days enfortumab vedotin on days 1, 8, and 15 every 28 days and trastuzumab deruxtecan on day 1 every 21 days. Imaging scans, biopsies, and blood sample collections are performed throughout the trial, with optional samples taken at progression. Echocardiography or MUGA scans are also used for patients receiving trastuzumab deruxtecan. Participants will undergo thorough assessments including CT and MRI imaging, tumor biopsies before and during treatment, blood collections, and heart function monitoring as applicable. Researchers will measure tumor response rates, progression-free survival, overall survival, molecular markers, and adverse events. After treatment ends, patients will be followed for up to three years with regular check-ins every 3 to 6 months to monitor outcomes and safety. This comprehensive monitoring helps understand the therapys impact and tumor changes over time.

This research aims to evaluate the safety, side effects, and best dose of SM08502 cirtuvivint alone and combined with ASTX727 in patients with acute myeloid leukemia AML and myelodysplastic syndromes MDS. The study focuses on relapsed or refractory AML and MDS, as well as frontline high-risk MDS. Cirtuvivint may work by blocking enzymes needed for cancer cell growth, while ASTX727 combines decitabine and cedazuridine to help bone marrow produce normal blood cells and kill abnormal cells. This phase I trial explores how these treatments affect patients, including their safety and potential anti-tumor activity. Participants are divided into three groups receiving different schedules of oral cirtuvivint Cohort I receives the drug daily on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle Cohort II receives it on days 1, 4, 8, 11, 15, 18, 22, and 25 and Cohort III receives the same cirtuvivint schedule as Cohort II plus ASTX727 on days 1-5. These cycles repeat every 28 days unless disease progression or unacceptable toxicity occurs. Before treatment, patients undergo heart function tests echocardiography or MUGA scan and blood and bone marrow sample collections. During the study, patients continue blood and bone marrow sampling to monitor their response and safety. After treatment, they are followed for 30 days, then every three months for two years, and every six months for up to three more years. Researchers measure the maximum tolerated dose, recommended phase 2 dose, adverse events, clinical response, event-free survival, and overall survival. This comprehensive monitoring helps evaluate the treatments effects and guide future development.

Researchers are evaluating whether adding paclitaxel chemotherapy directly into the abdominal cavity, alongside chemotherapy given through a vein, can better control the spread or growth of gastric cancer that has spread to the abdominal cavity. The study compares this combination approach to the usual chemotherapy treatment for this cancer type. The trial includes a surgical procedure called diagnostic laparoscopy to examine the abdomen and determine the appropriate treatment group for each participant. Participants will undergo diagnostic laparoscopy under general anesthesia, during which they will be randomly assigned to one of two groups. One group receives standard chemotherapy through the vein alone, while the other group receives the same chemotherapy plus paclitaxel delivered directly into the abdomen via an intraperitoneal port placed during surgery. Treatment cycles occur every 21 days for four cycles, with assessments after three months to decide whether to continue treatment or consider surgery to remove the cancer if possible. During the study, participants will have regular imaging scans such as CT or MRI to monitor disease status and blood samples collected periodically. After completing treatment, follow-up visits occur every three months for the first two years and then every six months up to five years to watch for side effects and cancer progression. Researchers will measure progression-free survival and overall survival to evaluate the treatments, along with monitoring adverse events related to the therapy.

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.