Greenlawn

This research aims to evaluate the safety and effectiveness of neoadjuvant carboplatin combined with mirvetuximab soravtansine in women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha FR. Mirvetuximab soravtansine is an investigational antibody drug designed to selectively target and kill cancer cells carrying FR. The study enrolls about 140 adult female participants with stage III or IV disease across approximately 80 sites in the United States. Participants receive intravenous infusions of mirvetuximab soravtansine together with carboplatin on the first day of each 21-day cycle, for up to 6 to 9 cycles. Bevacizumab may also be given at the investigators discretion. This single-group study includes regular treatment cycles over a period lasting approximately three years. During the study, participants will have frequent visits to hospitals or clinics for medical assessments, blood tests, and scans to monitor their health and response to treatment. Researchers will measure outcomes including tumor response based on independent central review, adverse events, disease control, progression-free survival, and symptom changes. Safety and treatment effects will be tracked throughout the study duration of about three years.

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 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.

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 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.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

Researchers are comparing two chemotherapy combinations for treating advanced, unresectable, or metastatic HER2 negative adenocarcinomas of the esophagus, gastroesophageal junction, and stomach. This phase III trial evaluates modified FOLFIRINOX fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan with or without nivolumab versus modified FOLFOX fluorouracil, leucovorin calcium, and oxaliplatin with or without nivolumab. Chemotherapy drugs act to stop tumor growth by killing cells or stopping division, and immunotherapy with nivolumab may affect the immune system to hinder tumor growth and spread. Participants are randomized into two groups one receives mFOLFIRINOX plus nivolumab as clinically indicated, and the other receives mFOLFOX plus nivolumab as clinically indicated. Treatments are administered intravenously. Throughout the study, participants undergo magnetic resonance imaging MRI, computed tomography CT scans, and may provide blood samples. Nivolumab is given as needed based on clinical assessment during the trial. Participants will be monitored up to 2 years from randomization for overall survival, with secondary measures including progression-free survival, response rates, duration of response, adverse events, and patient-reported outcomes collected at baseline and during treatment cycles. Safety and tolerability are evaluated, and exploratory analyses include biomarker assessments such as PD-L1 combined positive score and cell-free DNA. The trial includes regular imaging and clinical assessments to track disease status and treatment effects.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

Researchers are evaluating the safety and effects of pressurized intraperitoneal aerosol chemotherapy PIPAC in patients with ovarian, uterine, appendiceal, colorectal, or stomach gastric cancer that has spread to the lining of the abdominal cavity, known as peritoneal carcinomatosis. This phase I trial aims to understand how PIPAC works in different groups of patients based on their primary cancer type, including identifying the maximum tolerated dose of one chemotherapy drug in a specific subgroup. The study also explores the ability to proceed to surgery, tumor response, progression-free survival, technical success of the procedure, patient quality of life, and functional status. Participants are assigned to one of three groups based on their cancer type and prior treatments. Treatments include PIPAC delivered chemotherapy drugs such as doxorubicin, cisplatin, oxaliplatin, mitomycin, along with intravenous drugs like leucovorin, fluorouracil, and irinotecan. Each group receives up to three treatment cycles every 4 to 6 weeks if there is no disease progression or unacceptable side effects. After treatment, patients are followed every 12 weeks for up to three years. During the study, participants undergo laparoscopic procedures to deliver chemotherapy and collect biopsies for tumor assessment. Imaging with CT scans and biopsy samples are used to evaluate tumor response. Researchers monitor side effects, surgical complications, and patient-reported symptoms and quality of life through questionnaires. Functional status is tracked using a wristband pedometer. The study measures dose-limiting toxicities and adverse events up to 18 weeks, with additional long-term follow-up extending to three years to assess progression-free survival and technical success of PIPAC.