Westerly

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

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.

This trial focuses on both women and men diagnosed with Stage I HER2-positive invasive breast cancer. It aims to compare two different combinations of HER2-targeted therapies given after surgery, studying how well each treatment controls the cancer and their side effects. The study is a randomized phase II trial supported by Genentech and led by the Dana-Farber Cancer Institute, evaluating long-term benefits and disease-free survival over several years. Participants are randomly assigned to one of two groups. One group receives six cycles of intravenous trastuzumab-emtansine T-DM1 every three weeks, followed by eleven cycles of subcutaneous trastuzumab every three weeks. The other group receives weekly intravenous paclitaxel for twelve weeks along with subcutaneous trastuzumab every three weeks, continuing trastuzumab alone for additional cycles. The entire treatment period lasts about one year. During the study, participants undergo screening and regular laboratory evaluations along with follow-up visits. Researchers monitor side effects, quality of life, symptoms related to therapy, and cardiac function. The main outcomes measured include the incidence of toxicities during the first 18 weeks and disease-free survival over up to 72 months. Participants are followed for five years after treatment to assess long-term outcomes and safety.

Researchers are evaluating the use of carboplatin chemotherapy given before surgery in patients with high-risk prostate cancer who have inherited mutations in the BRCA1 or BRCA2 genes. This phase II trial aims to determine how well carboplatin works in shrinking tumors prior to surgery and to assess its impact on disease progression and survival. The study also monitors treatment side effects and collects tissue samples for future research. Participants receive carboplatin intravenously before undergoing prostate surgery. Those who show signs of disease progression after surgery will have imaging tests such as CT, MRI, chest X-ray, or PSMA PET scans. Blood samples are collected throughout the trial to monitor health and support additional studies. The study includes detailed follow-up to evaluate treatment outcomes and safety. During the trial, participants will have regular assessments including physical exams, PSA tests, and imaging scans if needed. Researchers will review the rate of complete tumor response after carboplatin treatment at surgery and track progression-free survival and overall survival over time. Safety and side effects of the treatment are closely monitored. Participation may last up to five years with ongoing collection of health data and specimens.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating treatment options for patients newly diagnosed with multiple myeloma who are considered frail or intermediate-fit and who are not candidates for stem cell transplant. This phase III trial compares three different three-drug induction regimens followed by either single or double drug maintenance therapies. The study aims to find which drug combination best controls the cancer and improves patient outcomes while considering patients age, other health conditions, and physical function. Participants are randomly assigned to one of three treatment arms. In Arm 1, patients receive bortezomib, lenalidomide, and dexamethasone with bortezomib given subcutaneously and the others taken orally for up to 9 cycles, followed by lenalidomide maintenance. Arm 2 involves daratumumab with hyaluronidase-fihj given subcutaneously, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. Arm 3 includes the same induction as Arm 2, but maintenance therapy combines daratumumab with hyaluronidase-fihj and lenalidomide. Each cycle lasts 28 days, and treatment continues without disease progression or unacceptable side effects. During the trial, participants undergo regular assessments including tumor measurements, blood tests, and quality-of-life questionnaires. Researchers monitor progression-free survival, overall survival, response rates, minimal residual disease status, and patient-reported symptoms and health status. After completing treatment, patients are followed up every 3 months for one year, every 6 months for two years, and then annually for up to 10 years to monitor long-term outcomes and safety.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.