Westmoreland County

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 II/III 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 II/III 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 to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III 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.

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.

Researchers are evaluating the effectiveness of two digital mindfulness-based interventions for younger breast cancer survivors who experience elevated depressive symptoms. This phase III clinical trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their primary cancer treatments at least six months prior. The study aims to identify which digital mindfulness approach best improves mental health and well-being, while exploring factors that influence intervention benefits and cost-effectiveness. The study includes three groups: one attends live, instructor-led mindfulness sessions via Zoom once a week for six weeks; another uses a self-paced mindfulness app with structured lessons and exercises over six weeks; and a control group accesses guided audio mindfulness meditations. Participants without digital devices or internet access will be provided with tablets and hotspots. Both English and Spanish speakers are included in live and audio meditation groups, while the app group includes English speakers only. All groups have access to the mindfulness app for up to six months. Participants will attend sessions or use digital tools over six weeks, with daily home practice encouraged. Researchers will assess depressive symptoms shortly after the intervention and up to six months later, along with fatigue symptoms. Use of mindfulness materials and session attendance will be tracked to measure engagement. The study also collects information on emotion regulation, demographic factors, and social determinants of health to understand how these influence outcomes. Participation lasts approximately six months, with ongoing access to mindfulness resources during follow-up.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase II/III 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.

Researchers are studying women with recurrent endometrial carcinoma that has a deficient mismatch repair system, a condition where the body's ability to repair damaged DNA is impaired. This trial aims to compare the combination of two immunotherapy drugs, nivolumab and ipilimumab, against nivolumab alone to see which better shrinks tumors in this specific type of cancer. The study focuses on patients whose cancer has returned after being undetectable for a time, including those with tumors linked to Lynch Syndrome, a hereditary condition causing DNA repair problems. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive intravenous nivolumab every three weeks and ipilimumab every six weeks for up to eight cycles, followed by nivolumab alone every four weeks. In the second group, patients receive nivolumab alone every three weeks for up to eight cycles and then every four weeks afterward. Patients who achieve a complete response continue nivolumab for an additional 12 months. Optional tissue and blood samples are collected throughout the trial, and imaging tests such as CT scans or MRIs are regularly performed. Throughout the study, patients are monitored with scans and assessments to measure disease progression, response to treatment, and side effects. Follow-ups occur every three months for two years, then every six months for three years. The main outcome measured is progression-free survival, tracking the time until the cancer worsens or the patient passes away. Secondary outcomes include overall survival, tumor response rates, and treatment-related side effects over up to five years of observation.

Researchers are evaluating the addition of pembrolizumab, an immunotherapy drug, to usual chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival between different treatment approaches, including chemotherapy alone and chemotherapy combined with pembrolizumab. The study also assesses quality of life, side effects, and the impact of tumor markers on outcomes. Patients are randomly assigned to one of two active treatment groups. One group receives standard chemotherapy every 21 days for 4 cycles followed by pembrolizumab given intravenously every 21 days or every 6 weeks for up to 17 cycles. The other group receives chemotherapy combined with pembrolizumab during the initial 4 cycles, followed by pembrolizumab alone for additional cycles. Chemotherapy regimens include combinations of cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel. A previous group receiving chemotherapy alone followed by observation is closed. Participants undergo various assessments including echocardiograms, MRIs, CT scans, and blood sample collections during the trial. They complete quality of life questionnaires and are monitored regularly for disease recurrence, side effects, and survival for up to 10 years. Follow-up visits occur every 3 months for 2 years, then every 6 months for years 2 to 4, and annually thereafter, providing long-term monitoring of treatment effects and safety.

This trial investigates how well cabozantinib works when combined with two immunotherapy drugs, nivolumab and ipilimumab, in treating patients with rare genitourinary tumors that have spread from their original site. These cancers include various rare bladder, kidney, penile, and urethral cancers. The study aims to measure how effectively this combination can shrink tumors and improve survival, while also assessing safety and collecting tissue for further research. Participants receive cabozantinib pills daily on specific schedules during treatment cycles. Nivolumab and ipilimumab are given intravenously on set days during early cycles, with nivolumab continued alone afterward. Treatment cycles repeat every 21 days initially and then every 28 days for up to two years, unless the cancer worsens or side effects become unacceptable. Patients may undergo scans like CT, MRI, PET/CT, and bone scans, as well as blood and urine tests throughout the study. During the study, patients have regular imaging and lab tests to evaluate tumor response and monitor health. Follow-up continues every two months for up to five years after treatment to assess outcomes such as tumor shrinkage, progression-free survival, overall survival, and side effects. The research team also supports tissue banking and evaluates treatment effects on bone disease. Safety and quality of life are monitored closely throughout this time.