Trumbull

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the effectiveness and safety of adding autogene cevumeran and atezolizumab to a chemotherapy regimen called mFOLFIRINOX compared to mFOLFIRINOX alone in patients who have had pancreatic ductal adenocarcinoma PDAC surgically removed. The study focuses on participants who have not previously received systemic treatment for PDAC and show no evidence of disease after surgery. This is a phase II, open-label, randomized trial sponsored by Genentech, Inc. Participants are randomly assigned to one of two groups one group receives autogene cevumeran and atezolizumab along with mFOLFIRINOX chemotherapy, and the other group receives only mFOLFIRINOX. All medications are administered intravenously at specified times. The trial includes monitoring over approximately six years to assess outcomes. During the study, participants will be regularly evaluated for disease recurrence or new cancers, survival, and side effects. The main measure is disease-free survival from randomization to the first recurrence or death. Additional assessments include survival rates at specific time points and monitoring adverse events. Participants will be followed closely with clinical assessments to track their health and response to treatment throughout the study period.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage stage I and II classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Researchers are evaluating the safety and effects of an investigational anticancer drug called PF-08046876 in adults with advanced cancers of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is a type of antibody drug conjugate ADC designed to attach to cancer cells and kill them. This phase 1 open-label study aims to explore different doses and schedules of this study drug to better understand its impact and safety in these advanced solid tumors. Participants will receive PF-08046876 through an intravenous infusion. The study has multiple parts the first part involves groups receiving varying doses and treatment schedules to find safe regimens. In the second part, participants will be randomized to two dosing schedules found safe in the first part or assigned to tumor-specific groups receiving one of these safe regimens. This design helps optimize dosing for further study. During the trial, participants will be closely monitored for treatment-related side effects, including dose-limiting toxicities and adverse events from the start of treatment up to 30 days after the last dose or new cancer therapy. Researchers will assess tumor response, progression-free survival, overall survival, and drug levels in the blood over about two to three years. Tumor tissue and immune cells will be examined before and after treatment to understand the drugs effects. The study may last several years depending on participant involvement and treatment response.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase IIIII trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

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 evaluating how newly diagnosed Stage I HER2-positive invasive breast cancer responds to one of two different combinations of HER2-directed therapies after surgery. The study compares the effects and side effects of trastuzumab-emtansine T-DM1 followed by subcutaneous trastuzumab versus paclitaxel combined with subcutaneous trastuzumab. This phase II randomized trial also aims to understand the long-term benefits and disease-free survival for participants treated with these therapies. Participants are randomly assigned to one of two treatment groups. The first group receives intravenous T-DM1 every three weeks for six cycles, followed by subcutaneous trastuzumab every three weeks for eleven cycles. The second group receives weekly intravenous paclitaxel for twelve weeks alongside subcutaneous trastuzumab every three weeks for the first four doses, then continues with trastuzumab alone every three weeks for seventeen cycles. Treatment lasts about one year in total. During the study, participants undergo screening and regular evaluations including laboratory tests and follow-up visits. Researchers monitor the occurrence of clinically relevant toxicities during the first 18 weeks and track disease-free survival for up to 72 months. Additional assessments include quality of life, symptoms related to therapy, side effects, cardiac function, gene profiling, and overall survival. Participants will be followed for five years after completing treatment to assess long-term outcomes.

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 colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.