Clinical Trials

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 characterize a landscape of DNA alterations, RNA transcripts, and microbiome changes in resected tumors and body fluids of patients that have been diagnosed with aggressive endometrial cancer (Grade 3 and Type II) in order to identify molecular targets for which therapeutic drugs may exist.

The purpose of this study is to evaluate sensitivity and specificity of 3D ultrasound in the assessment of tumor diameter and myometrial invasion in endometrial cancer in a pre-operative setting. This research is aiming to avoid the performance of sentinel node biopsy in patients at low risk of lymphatic spread.

The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).

The purpose of this study is to develop a unique data and specimen model for a biobank that can be expanded across the Mayo Enterprise and implemented at extramural collaborative sites, including underserved populations.  The targeted demographic will be African American and white women undergoing hysterectomy for benign conditions or endometrial cancer (EC). 

The purpose of this study is to anaerobically (completely without oxygen) isolate and culture the bacteria species from the uterus that are believed to be associated with endometrial (the lining of the uterus) cancer. This will allow further tests to assess interactons between the bacteria, and between the bacteria and the host cells.

The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).

The purpose of this research study is to learn more about serous endometrial cancer by creating three-dimensional (3-D) tissue models in the laboratory setting.  The tissue models will provide scientists with a reliable, sensitive method to test biomarkers and cellular responses to treatment for endometrial cancer.   

The purpose of this study is to evaluate the safety and tolerability of the combination of DS-8201a in combination with olaparib, and to determine the recommended phase 2 dose (RP2D) 1.1.2 To evaluate the safety and tolerability of this combination in a dose expansion cohort in patients with uterine serous carcinoma.

The purpose of this study is to prospectively validate a new Artificial Intelligence (AI)-based model developed by our team to analyze TVUS images for early EC detection.  

The purpose of this study is to assess the 36-month incidence of pelvic/non-vaginal recurrence among patients with surgical stage I intermediate-risk endometrial cancer.

Eligible patients presenting with apparent uterine confined grade 1, 2, or 3 endometrioid endometrial cancer will undergo standard-of-care primary surgical treatment with a cervical injection of indocyanine green (ICG) dye for SLN mapping, a total hysterectomy, removal of the adnexae and staging with sentinel node mapping and pelvic washings. 

The final assessment for inclusion in the follow-up part of the study will be determined from the results of the final hysterectomy and staging pathology report to ensure bilaterally negative pelvic sentinel ...

The purpose of this study is to generate preliminary data for a risk stratification model for recurrence including traditional histopathologic risk factors, molecular characterization in endometrial cancer patients with features of aggressive disease.  

The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.

The purpose of this study is to positively impact endometrial cancer (EC) survivorship through a fully remote home-based exercise program. We believe this type of survivorship care will be accessible, sustainable, and scalable. We seek to design and implement a telehealth strength-based exercise intervention in rural EC survivors, a group currently overlooked in most survivorship studies.

The purpose of this study is to compare the incidence of cuff dehiscence in patients who have undergone total robotic laparoscopic hysterectomy vs. total vaginal hysterectomy, to identify risk factors for cuff dehiscence, and to study the impact of cuff dehiscence on a patient’s psychological well-being.

The purpose of this study is to identify those clinical, immunochemical, or molecular risk factors associated with an increased risk of distant recurrence in “high-intermediate” risk endometrial cancer patients. 

The purpose of this study is to determine 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 (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 ...

The purpose of this study is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.

The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy

The purpose of this study is to evaluate the usability and efficacy of Flyte, a home-based transvaginal mechanotherapy device, in the treatment of urinary incontinence in women who have received adjuvant radiation therapy, and to measure the associated improvement in overall quality of life. A secondary objective includes the feasibility of using the Flyte System to improve access to urinary incontinence treatment for patients in rural areas or those who experience difficulties traveling for in-person care.

The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.

The purpose of this randomized phase II trial study is to determine how well olaparib, cediranib maleate, and Week 1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) 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.

The purpose of this study is to collect vaginal and endometrial cell samples to study endometrial cancer.

The purpose of this phase II ComboMATCH treatment trial is to compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway.  

The goal of this study is to identify circulating tumor DNA in the preoperative blood samples of endometrial cancer patients and detect changes in the quantity and tumor-specific mutations and chromosomal rearrangements in circulating tumor DNA of patients with endometrial cancer.

The purpose of this study is to investigate the value of ultrasound imaging of microscopic blood vessels as a new biomarker for identifying the difference between benign and cancerous uterine pathologies, and to compare ultrasound imaging to the diagnostics of MRI and (if available), surgical pathology.

The purpose of this study is to validate a non-invasive diagnostic test with both high-sensitivity and negative predictive value (NPV) for its ability to rule out endometrial cancer.

The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.  

The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.

The purpose of this study is to quantify the extent of sexual dysfunction in our patients to explore if there is a need for a prospective intervention, with the ultimate goal of improving the quality of life of our patients, with respect to sexual function.

The purpose of this study is to identify the recommended Phase 2 dose (RP2D) of LY3484356 administered as monotherapy and in combination with other anticancer therapies in patients with locally advanced or metastatic ER+ breast cancer or ER+ recurrent, persistent, or metastatic endometrial endometrioid cancer (EEC).

This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.

This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing ...

This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. (CRC and melenoma cohorts are now closed to new patients)

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.

The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.

The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors.  A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...

The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.

GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.

The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.