Bismarck

Researchers are evaluating the effectiveness of pemigatinib in adults with advanced or metastatic pancreatic cancer that has spread to nearby tissues, lymph nodes, or distant body parts, and that have specific genetic changes in the FGFR gene. The study focuses on patients whose cancer has FGFR2 gene fusions or other FGFR alterations, aiming to see if pemigatinib can block these abnormal gene functions to stop tumor growth and possibly improve quality of life. This is a phase II trial conducted nationwide using a fully decentralized telemedicine approach to reach participants. Participants receive pemigatinib as an oral medication once daily for 14 days within each 21-day cycle. Treatment continues unless the disease progresses or unacceptable side effects occur. Alongside the drug treatment, patients undergo various imaging tests including CT scans, MRI, optical coherence tomography (OCT), and when needed, whole body bone scans and dilated eye exams (ophthalmoscopy). After finishing treatment, patients are followed up at 30 days and then every four months for one year to monitor their condition. Throughout the study, patients provide blood samples and undergo scans to evaluate treatment response and detect resistance mutations. Researchers track the overall response rate for up to 24 months and assess safety and tolerability. Patients must comply with scheduled visits, tests, and oral medication intake. The total study participation includes treatment cycles and a follow-up period lasting up to approximately 16 months after treatment completion.

Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab in patients with advanced or locally unresectable stomach or esophageal adenocarcinoma. This phase II/III trial aims to determine if adding nivolumab improves progression-free survival and overall survival compared to paclitaxel and ramucirumab alone. The study also assesses response rates, disease control, safety, tolerability, and quality of life in participants with PD-L1 CPS 21 1 advanced gastric or esophageal cancer. Participants are randomly assigned to one of two treatment groups. The first group receives nivolumab IV on day 1 of each 28-day cycle, ramucirumab IV on days 1 and 15, and paclitaxel IV on days 1, 8, and 15. The second group receives ramucirumab IV on days 1 and 15 and paclitaxel IV on days 1, 8, and 15 of each cycle. Treatment continues every 28 days until disease progression or unacceptable side effects occur. Optional blood samples may be collected during the study. Imaging with CT and MRI is performed throughout. Participants undergo scans and assessments at baseline and during treatment to monitor cancer progression and treatment effects. They also complete questionnaires on quality of life and symptoms. After treatment ends, participants are followed up at 30, 60, and 90 days and then every 6 months for up to 3 years. Researchers measure progression-free survival and overall survival as primary outcomes, along with other safety and patient-reported measures.

Researchers are evaluating the effects of adding cemiplimab, an immunotherapy drug that blocks the PD-1 pathway to help the immune system attack tumor cells, to the usual treatment of docetaxel and ramucirumab in patients with stage IV or recurrent non-small cell lung cancer. This phase II/III Expanded Lung-MAP trial compares cemiplimab combined with docetaxel and ramucirumab versus docetaxel and ramucirumab alone, aiming to improve treatment outcomes in patients who previously received platinum chemotherapy and immunotherapy but developed resistance or disease progression. Participants are randomly assigned to one of two treatment arms. In Arm I, patients receive dexamethasone orally twice daily on days 0-2, ramucirumab and docetaxel intravenously on day 1 of each 21-day cycle. In Arm II, patients receive the same treatments plus cemiplimab intravenously on day 1 of each cycle. Treatment cycles continue every 21 days until disease progression or unacceptable side effects occur. Throughout the study, patients undergo regular blood sample collection and imaging scans such as CT or MRI to monitor disease status. During the study, participants are closely monitored with scans, blood tests, and physical exams to assess overall survival and other outcomes like progression-free survival, response rates, and treatment safety. Researchers also collect blood samples for future molecular studies. After completing treatment, patients are followed up every 3 to 6 months for up to 3 years to track long-term survival and health status. The study measures overall survival from randomization to death from any cause, assessed up to 3 years.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.

This research evaluates the combination of two drugs, cabozantinib and nivolumab, in treating patients with advanced melanoma or squamous cell cancers of the head and neck that have spread locally or to distant parts of the body. The study focuses on how well patients can be grouped based on specific tumor biomarkers called tumor mutational burden and tumor inflammation signature. It also aims to understand if this drug combination can shrink or stabilize tumors and how responses vary with biomarker status. This is a phase II trial assessing both the feasibility of biomarker-based patient grouping and the treatment's overall response rate. Participants receive nivolumab intravenously once every 28-day cycle and take cabozantinib orally every day for up to two years unless the disease worsens or side effects become unacceptable. The study includes two stages focusing on molecular characterization and treatment efficacy. Patients undergo tumor biopsies at screening and optionally during follow-up, along with regular imaging scans like CT or MRI and blood sample collections throughout the study. During the trial, patients are closely monitored through scans, blood tests, and biopsies to track tumor response and safety. After treatment ends, follow-up visits occur every 12 weeks for one year and then every six months for up to three years. Key outcomes include the time to get biomarker results within 21 days and the overall tumor response rate at the end of the first stage. The study also assesses disease control, progression-free survival, overall survival, and safety of the drug combination in relation to tumor biomarkers.

Researchers are evaluating how well chemotherapy given before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus squamous cell carcinoma that can be removed by surgery. This phase II randomized trial focuses on patients with locally advanced resectable tumors classified as T3 or T4a stages, aiming to preserve important structures like the skull base and orbit, and to improve overall survival. The study also examines additional outcomes such as progression-free survival, the accuracy of imaging predictions, and the effects of tobacco use on treatment and symptoms. Participants are randomly assigned to one of two groups. One group undergoes standard surgery followed by image-guided intensity-modulated radiation therapy (IMRT) daily for 30 treatments starting 4-6 weeks after surgery, with additional chemotherapy (cisplatin or carboplatin) if certain high-risk features are present. The other group receives up to three cycles of chemotherapy including docetaxel and cisplatin (or carboplatin if cisplatin is not suitable), followed by surgery within six weeks. After surgery, they receive the same radiation therapy and additional chemotherapy as needed. The study includes correlative biomarker and questionnaire analyses. Throughout the study, participants have evaluations including magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) scans before registration and during treatment. After completing therapy, patients are followed every three months for up to two years, then every six months up to five years to monitor structure preservation and survival outcomes. Researchers also assess treatment side effects, physical and psychological symptoms, and tobacco use behaviors during this time.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.

Researchers are studying treatments for patients with peritoneal mesothelioma, a rare cancer affecting the lining of the abdomen. This phase II trial compares the usual treatment of carboplatin, pemetrexed, and bevacizumab, which involves chemotherapy and surgery, with a combination that adds immunotherapy using atezolizumab. The goal is to see if adding immunotherapy improves the response rate and other outcomes such as safety, surgery success, metabolic response, and survival. Participants are randomly assigned to two groups. One group receives intravenous atezolizumab, bevacizumab, carboplatin, and pemetrexed every 21 days for up to 4 cycles, followed by surgery and heated chemotherapy delivered inside the abdomen (HIPEC) within 4-8 weeks. Those not eligible for surgery continue maintenance therapy with atezolizumab and bevacizumab every 21 days. The other group gets bevacizumab, carboplatin, and pemetrexed on the same schedule, followed by surgery and HIPEC or maintenance therapy with bevacizumab, with or without atezolizumab, depending on the doctor's decision. During the study, patients undergo CT and PET scans and provide blood and tissue samples to monitor treatment effects. After treatment ends, participants are followed every six months for up to three years to assess response and safety. The main outcome measured is the tumor response rate up to four years after starting the trial.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.