This trial is evaluating whether IMGN853 will improve 1 primary outcome and 4 secondary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of 5 Years.
This trial requires 50 total participants across 2 different treatment groups
This trial involves 2 different treatments. IMGN853 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Many of the [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer)s can be cured in cases where the tumors are less aggressive and there are no other cancer cells in the body. The more aggressive forms of endometrial tumors can not be cured in any cases, but good treatment can reduce symptoms to a great degree in many cases. It is important to remember that endometrial neoplasm cannot be cured, but good treatments may be able to reduce their size, severity, and recurrence.
Treatment of endometrial adenocarcinoma and endometrial sarcoma vary dependent on the type, grade, and the spread of the tumor. In endometrial adenocarcinoma, surgery can be useful if it has a curative intent. Radiation may improve outcomes in patients who have locally advanced or metastatic disease. Endometrial sarcoma often responds well to chemotherapy, surgery, and radiation therapy. In advanced endometrial cancer surgery and chemotherapy alone may result in long-term survival. Adjuvant therapy with chemotherapy, hormonal therapy, or radiotherapy is recommended for high-grade serous endometrial adenocarcinoma.
About 1.8 million people are diagnosed with endometrial neoplasms per year in the United States. This makes up 0.5% of women 30 years and older. Most people who develop endometrial neoplasms are diagnosed every 5 to 10 years. The majority of endometrial cancer occurs in postmenopausal women.
Endometrial neoplasms are common, benign tumor and carcinoma accounted for 71.6% and 12.9% of cases in this study, respectively. The percentage of low grade endometrial neoplasms increased in the postmenopausal women of both age groups.
There is an association between endometrial polyps and endometrial cancer. These symptoms may prompt a medical practitioner to consider an endometrial biopsy in women with polypoid endometrium.
Women with a personal history of endometrial cancer are more likely to have adenocarcinoma but not SCC. Women with adenocarcinoma have a shorter duration of symptoms and atypical symptoms such as gastrointestinal hemorrhage and abnormal vaginal bleeding. Women with no personal history of endometrial cancer are unlikely to have adenocarcinoma. Endometrioid adenocarcinoma is associated with hyper-estrogenism due to the secretory properties of adenocarcinomas while serous adenocarcinoma may be associated with hormonal replacement.
Given the increasing number of treatment options of endometrial neoplasms, we anticipate the arrival of new discoveries, and we will have to continue to update our recommendations.
Imgn853, originally developed as an alternative therapy for treatment of prostate cancer, displayed clear effects in endometrial cancer, an action mediated through the down-regulation of the cell proliferation-related gene P53. In addition, our results suggest that the drug exerts its cytotoxic effects in part through modulation of the cell cycle regulators, cyclins and c-myc, thus indicating a crucial position also for P53 in regulating cell cycle events mediated by the endometrial neoplasm and in the development of new imgn853-based strategies.
There is statistical significant difference in favour of Imgn853 compared to a placebo which suggests Imgn853 is more effective than a placebo when all patients are pooled. However, further studies should prove superiority of Imgn853 compared to a placebo on individual patient basis before it can be recommended in the treatment of uterine leiomyoma.
Endometrial neoplasia is a rare disease, but is often found in women who have a history of endometrial hyperplasia or carcinoma. Survival rates seem to be comparable in a recent study for endometrial adenocarcinoma and adenocarcinoma of the endometrium, although complete surgical staging was not performed. When metastasic adenocarcinoma occurs, the outcome seems to be poor as well. Follow-up must be kept up by gynecologists to monitor recurrence as well as detecting any sign of metastatic disease.