715 Clinical Trials for Various Conditions
DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer survivors are at an increased risk of other health conditions like heart disease, diabetes, and other cancers. The study team at the University of Virginia wants to explore new ways to lower these risks. This study will be evaluating the Anticancer Lifestyle program, which takes a more holistic approach and uses web-based learning modules along with weekly group sessions to discuss each topic of the web-based learning modules.
This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.
This clinical trial studies how well a remotely delivered home-based exercise program for strength training works to positively impact endometrial cancer (EC) survivorship for patients with decreased cancer survivorship access. Cancer survivors in rural areas face barriers to supportive care, including geographic and environmental barriers to exercise and technology. Rural areas in the Midwest are underserved in terms of cancer care thus, it is essential to develop and test interventions that are scalable and can reach many individuals including those living in rural areas. Remotely-delivered exercise intervention approach allows for cancer survivors who may live far away from their primary treatment center to engage in supportive therapy via exercise interventions delivered in a sustainable context. In addition, historically black, hispanic and native endometrial cancer survivors have shorter survival and less access to survivorship care, so alternative models for healthcare delivery are needed in this underserved group. Information gained from this research may help determine whether utilizing a remotely delivered exercise program can positively impact EC survivorship for patients with decreased cancer survivorship access.
This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.
This phase I trial tests the safety, side effects, and best dose of combination therapy with pelcitoclax (APG-1252) and cobimetinib in treating patients with ovarian and endometrial cancers that have come back after a period of improvement (recurrent). APG-1252 is a drug that inhibits activity of proteins that prevent cell death, leading to increased cell death and reduced cell growth. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving APG-1252 in combination with cobimetinib may shrink or stabilize tumor in patients with recurrent ovarian and endometrial cancers.
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
This study is to find out how well liquid biopsies work as a non-invasive alternative to other methods of finding cancer cells (such as a tissue biopsy) in patients with endometrial cancer. A liquid biopsy is a blood test that may be able to find cancer cells. Collecting and storing samples of blood and tissue from patients with endometrial cancer to study in the laboratory may help doctors learn how the cells in the blood may change during treatment for uterine cancer.
This clinical trial evaluates the effect of tislelizumab in treating patients with mismatch repair deficient endometrial cancer that has come back (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing DNA errors and damage. Mismatch repair deficient tumors (dMMR) may have difficulty repairing DNA mutations during replication that may affect tumor's response to therapy. Immunotherapy with monoclonal antibodies, such as tislelizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tislelizumab may help treat patients with mismatch repair deficient endometrial cancer.
This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.
Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients. Primary Outcome Stage 1: Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities. Primary Outcome Stage 2: Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results.
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.
Programmed cell death 1 (PD-1) inhibitor treatment may benefit patients with endometrial cancer (EC) based on the following observations: 1) an overwhelming presence of PD-1 in ECs; 2) the well-known effect of obesity which activates pro-inflammatory white blood cells and promotes the development of ECs; and 3) the high prevalence of a specific gene pattern (ie, microsatellite instability hypermutated \[MSI high\]) among ECs that may be particularly sensitive to this class of drugs. To identify potential biomarkers of response to PD-1 inhibitors in EC, we will conduct a window of opportunity study of pembrolizumab in 20 patients with clinical stage 1, grade 3 EC, encompassing endometrioid, serous and clear cell histologies. Eligible patients will undergo a research biopsy for collection of fresh tissue at the time of enrollment, in addition to the routinely performed endometrial biopsy that led to the diagnosis of their cancer. Patients will receive a single dose of pembrolizumab (200 mg IV) prior to undergoing their scheduled hysterectomy with surgical staging three weeks later. As per standard of care, adjuvant chemotherapy with paclitaxel and carboplatin will be recommended after hysterectomy/surgical staging for women with endometrioid tumors and stage III disease or women with serous/clear cell tumors at all stages of disease. However, in this study pembrolizumab will be added to adjuvant paclitaxel and carboplatin for EC. Pre-treatment endometrial biopsy specimens (fresh frozen tissue and formalin-fixed paraffin embedded (FFPE)) and a post-treatment hysterectomy specimen (fresh frozen tissue and FFPE) will be collected for translational studies. Blood, fecal and vaginal samples will be collected pre-treatment, at the time of surgery and following 3 cycles of adjuvant pembrolizumab/paclitaxel/carboplatin treatment.
This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.
18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the image interpretation is not affected by nonspecific urine activity in the ureters and bladder, which is advantageous for pelvic imaging. Recent literature suggests that Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new opportunities for noninvasive probing of glutamine metabolism and clinical use in patient management. Current literature indicates that amino acid transporters including that of glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic malignancies. Given the lack of current clinical data, a pilot study providing a direct comparison of Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical cancer and endometrial cancer. This research will compare the diagnostic performance of the research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory endpoint.
This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells. After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.
This randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.
This randomized phase II trial studies how well cabozantinib s-malate and nivolumab work in treating patients with endometrial cancer that has come back (recurrent) or spread to other places in the body (advanced or metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may work better in treating endometrial cancer.
This phase II trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back (recurrent). Chemotherapy drugs, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
This phase II trial studies how well everolimus and letrozole with or without ribociclib work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs such as everolimus and letrozole have been shown to be effective at stopping tumor growth either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.
This phase II trial studies how well copanlisib works in treating patients with endometrial cancer that has not decreased or disappeared, and the cancer may still be in the body despite treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
This phase II trial studies how well enzalutamide, carboplatin, and paclitaxel work in treating patients with endometrioid endometrial cancer that is stage III-IV or has come back. Androgens can cause the growth of endometrioid endometrial cancer. Antihormone therapy, such as enzalutamide may lessen the amount of androgen made by the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving enzalutamide, carboplatin, and paclitaxel may work better in treating patients with endometrioid endometrial cancer.
This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in patients with ovarian, fallopian tube, primary peritoneal, or endometrial cancer.
This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.
This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight.
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.