Bismarck

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are evaluating the effect of adding intensity-modulated post-operative radiation therapy I-PORT to standard chemotherapy or immunotherapy in patients with non-small cell lung cancer NSCLC who still have lymph node cancer after surgery. This phase II trial aims to see if I-PORT improves disease-free survival and whether it increases serious heart or lung side effects compared to standard care alone. The study also looks at overall survival, cancer control, and patient-reported symptoms related to heart and lung health. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy or immunotherapy alone, continuing treatment if the cancer does not progress or side effects are manageable. The other group receives I-PORT once daily Monday through Friday for 5 to 6 weeks, starting 4 to 12 weeks after surgery, followed by the same standard chemotherapy or immunotherapy. Imaging scans and blood samples are collected during treatment in both groups. After completing treatment, participants are followed for five years with check-ups every three months for two years, then every six months for three years. During these visits, researchers assess disease recurrence, survival, side effects, and patient symptoms. The study uses various scans including CT, MRI, and FDG-PET, along with blood tests, to monitor participants health and treatment impact over time.

Researchers are evaluating the effectiveness and safety of a combination treatment including BMS-986489 a fixed dose combination of BMS-986012 and Nivolumab with Carboplatin plus Etoposide compared to Atezolizumab combined with Carboplatin plus Etoposide as a first-line therapy for participants with extensive-stage small cell lung cancer. This is a randomized, double-blind, multicenter phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive either the experimental combination of BMS-986489 with Carboplatin and Etoposide or the comparator regimen of Atezolizumab with Carboplatin and Etoposide. Doses are given on specified days according to the study protocol. The study examines these treatments as initial therapy for this type of lung cancer. During the trial, participants will be closely monitored for overall survival over a period of up to 5 years. Researchers will also measure other outcomes such as time to clinical decline based on lung cancer symptom scores, response duration, progression-free survival, and the occurrence of adverse events up to 135 days after the last treatment. Regular assessments will include imaging and clinical evaluations to track treatment effects and safety throughout the study.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab compared to paclitaxel and ramucirumab alone in patients with advanced stomach or esophageal adenocarcinoma. This phase IIIII trial aims to see if nivolumab improves progression-free survival and overall survival in these patients. Nivolumab is an immunotherapy monoclonal antibody that may help the immune system attack cancer, while ramucirumab may prevent tumor blood vessel growth, and paclitaxel stops cancer cells from dividing. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, combined with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives only ramucirumab and paclitaxel on the same schedule without nivolumab. Treatment cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients undergo CT scans and MRI imaging, and may optionally provide blood samples. Throughout the trial, participants are monitored with regular imaging and optional blood tests. After treatment ends, patients have follow-up visits at 30, 60, and 90 days, then every six months for up to three years. Researchers assess progression-free survival, overall survival, response rates, disease control, safety, and quality of life using questionnaires and patient-reported symptoms. This comprehensive monitoring helps evaluate treatment effects and patient well-being over time.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

This research aims to evaluate the combination of two drugs, cabozantinib and nivolumab, in treating advanced melanoma or squamous cell head and neck cancer that may have spread locally or to distant parts of the body. The study focuses on how these drugs affect tumor growth and the immune systems ability to fight cancer. It also investigates how quickly patients can be grouped based on tumor biomarkers, specifically tumor mutational burden and tumor inflammation signature, to understand differences in treatment responses. Participants receive nivolumab through intravenous infusion on the first day of each 28-day cycle and take cabozantinib orally every day. Treatment cycles continue for up to two years unless the disease progresses or side effects become unacceptable. During the study, patients undergo CT or MRI scans and blood sample collections. Tumor biopsies are taken during screening and may be repeated during follow-up. After treatment ends, participants are monitored every 12 weeks for one year and then every six months for up to three years. Throughout the trial, participants are assessed with imaging scans and blood tests to monitor cancer status and treatment effects. Researchers measure the time to receive biomarker results and evaluate tumor response rates. They also track safety, disease control, progression-free survival, and overall survival over the two years of treatment. Specimens are banked for future research. Participants remain under observation for several years after treatment to gather long-term data on outcomes and safety.

This trial evaluates treatment approaches for patients with locally advanced nasal and paranasal sinus squamous cell carcinoma that can be removed by surgery. It compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to assess organ preservation rates, overall survival, and progression-free survival, along with the accuracy of imaging predictions and the effects of tobacco use on treatment outcomes and patient symptoms. Participants are randomly assigned to one of two treatment groups. One group undergoes standard surgery followed by image-guided intensity-modulated radiation therapy IMRT and may receive cisplatin or carboplatin chemotherapy during radiation if certain risk factors are present. The other group receives up to three courses of chemotherapy with docetaxel and cisplatin or carboplatin before surgery, followed by the same radiation and chemotherapy approach. Chemotherapy is administered intravenously, and radiation is given daily for 30 treatments over several weeks. During the study, participants have imaging scans such as MRI and PETCT before and after chemotherapy to evaluate tumor status and organ preservation. After treatment, patients are monitored with follow-up visits every three months for up to two years, then every six months up to five years. The research team collects laboratory tests, questionnaires, and clinical assessments to measure survival outcomes, organ preservation, treatment side effects, and patient-reported symptoms throughout the study period.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

This trial studies adults with malignant peritoneal mesothelioma, comparing standard treatment alone to standard treatment combined with immunotherapy using atezolizumab. It aims to determine if adding atezolizumab to chemotherapy and bevacizumab improves response rates and survival. The study also explores safety, metabolic responses, surgical outcomes, and blood-based biomarkers related to treatment effects. Participants are randomly assigned to one of two groups. One group receives a combination of atezolizumab, bevacizumab, carboplatin, and pemetrexed intravenously every 21 days for up to four cycles, followed by cytoreductive surgery and HIPEC within 4 to 8 weeks. Those not eligible for surgery continue maintenance treatment with atezolizumab and bevacizumab. The other group receives bevacizumab, carboplatin, and pemetrexed on the same schedule, followed by surgery and HIPEC or maintenance bevacizumab with or without atezolizumab. Throughout the study, participants undergo CT and PET scans and provide blood and tissue samples for analysis. After completing treatment, patients are followed every six months for up to three years to assess outcomes including response rates, survival, safety, and pathological effects. The study measures these outcomes using imaging criteria and clinical evaluations to understand treatment benefits and risks.