This trial is evaluating whether Durvalumab will improve 1 primary outcome, 8 secondary outcomes, and 9 other outcomes in patients with Uterine Cervical Neoplasms. Measurement will happen over the course of Estimated to be up to 20 weeks.
This trial requires 770 total participants across 2 different treatment groups
This trial involves 2 different treatments. Durvalumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Uterine polyps and cervical cancer are the most common gynecologic problems in the first two years after childbirth. However, with prompt early diagnosis, the prognosis of these malignant tumors will be very good.
Common treatment for uterine cervical neoplasms involves hysterectomy (removal of the uterus) as the removal of the body of the uterus is used to treat all uterine cervical neoplasms, especially cervical cancer. Lymphadenectomy (removal of lymph nodes from the pelvis and abdomen) is almost used to treat cervical cancer and most uterine cervical neoplasms. Cessation of menstruation (complete or partial menstrual cessation) is often used by surgeons to treat uterine cervical neoplasms since it may decrease the likelihood of recurrence of the tumor. Surgery is also used to treat uterine cervical neoplasms, particularly in cases of carcinoma.
The American College of Surgeons estimates that there will be 5,000 new cases of cervical cancer, 5,400 new cases of invasive adenocarcinoma, and 7,400 new cases of other cervical neoplasms for the year 2006 in the United States.
Different types of cervical neoplasms may have differing causes; however, there appears to be no major difference between the two main types. There is evidence that smoking is a major risk factor for cervical neoplasms, particularly those of the squamous epithelium.
There are many clinical signs of [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer). The most important signs are vaginal bleeding or bleeding after sexual intercourse, and pain and/or discomfort during sexual intercourse and pelvic pain. The symptoms are mainly the same in squamous cell carcinoma and adenocarcinoma of the cervix. Most often a person who has symptoms of a cervix cancer is already dead when diagnosed with the cervical cancer.
The most common type of cervical neoplasm (squamous cell carcinoma) is a locally advanced tumor. A total LEEP cannot be performed. With these considerations, our findings do not support the possibility of a cure in patients with uterine cervical neoplasms.
Patients must consider the importance and risks in taking part in clinical trials and also must understand the fact that trials on uterine cervix are generally based on less information than for other organs, and they are often of low quality.
While several diagnostic and histopathological parameters have been established for uterine cervical neoplasms (carcinoma/adenocarcinoma/adenomyoma/endometrioid carcinoma/clear cell carcinoma), they provide limited information for disease evaluation. Moreover, the most frequently used prognostic parameters are not validated, and a comprehensive approach for assessing uterine cervical neoplasms needs to be established. It may be necessary to apply an algorithm-based approach to the management of uterine cervical neoplasms. Further investigation of the clinical utility of this approach should be done.
Uterine cervical cancer has no definitive treatment. Radical surgery is a very effective method of curative. It shows high cure rate and reduces the mortality. Cervical stenting is a new method in managing the patients and reducing the time to treatment, and it is helpful to increase the rate of survival of patients with uterine cervical cancer.
Durvalumab is a human monoclonal antibody that selectively targets human PD1 (B7-H3) and is the first anti-PD1 antibody approved for use in the United States by an FDA. It is not approved for any other disease, but it is being used in many clinical trials in different tumor types.Durvalumab monotherapy was found to not be effective, but it significantly increased the overall survival of patients with EOC-MCL when compared to docetaxel monotherapy.
Durvalumab significantly improved physical HRQoL when compared with placebo after 4 months of therapy. Moreover, durvalumab induced a significant response shift toward a better QoL. Results from a recent paper indicate that durvalumab may favorably influence HRQoL. Results from a recent paper are in line with the well-documented clinical anti-tumor effect of durvalumab and could potentially be used to influence the treatment choice in the future in patients with uterine cervical neoplasms.
Findings from a recent study revealed that the most frequent pathological finding in uterine cervical neoplasms was the keratinized squamous papillary carcinoma. In addition, hyperpapillary lesion had the highest risk factors. Therefore in the light of this information, uterine cervical biopsy should be considered from patients who have no uterine bleeding in particular with hyperpapillary uterine cervical neoplasms.