Durvalumab for Uterine Cervical Neoplasms

Phase-Based Estimates
2
Effectiveness
3
Safety
Research Site, Johannesburg, South Africa
Uterine Cervical Neoplasms+1 More
Durvalumab - Biological
Eligibility
18+
Female
Eligible conditions
Uterine Cervical Neoplasms

Study Summary

This study is evaluating whether a drug called durvalumab can improve the survival of women with cervical cancer.

See full description

Eligible Conditions

  • Uterine Cervical Neoplasms
  • Locally Advanced Cervical Cancer

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

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.

Year 5
The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT in terms of Progression-Free Survival (PFS)
Year 5
The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by the time from the date of randomization until death due to any cause in terms of Overall Survival (OS)
Year 5
Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0)
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by abnormality in clinical chemistry.
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by abnormality in hematology(cells/L).
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by abnormality in hematology(g/L).
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by electrocardiograms (ECGs)
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(blood pressure).
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(pulse rate) in beats per minute.
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(respiration rate) in breaths per minute.
The safety and tolerability of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by vital signs(temperature) in degree Celsius.
Week 20
The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by proportion of patients with a complete response at the first tumor assessment after chemoradiotherapy in terms of Complete Response (CR) rate
Year 5
The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by the number (%) of patients with at least one visit response of Complete Response (CR) or partial response (PR) in terms of Objective Response Rate (ORR)
Year 5
Disease-related symptoms and health related quality of life (HRQoL) in patients treated with durvalumab + SoC CCRT compared with placebo + SoC CCRT as assessed by the change from baseline in disease-related symptoms and HRQoL
The efficacy of durvalumab + SoC CCRT compared to placebo + SoC CCRT as assessed by time from detection of CR until the date of disease progression in terms of Duration of Response (DoR) in patients with a Complete Response (CR)
The efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of PFS in PD-L1 positive patients
To further assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of Proportion of patients alive and progression-free at 3 years (PFS 3 year).
Year 5
The efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of OS in PD-L1 positive patients

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Placebo (matching placebo for intravenous infusion)
Durvalumab (intravenous infusion)
Placebo group

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.

Durvalumab (intravenous infusion)durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
Placebo (matching placebo for intravenous infusion)placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Durvalumab
FDA approved
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: estimated up to 4.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly estimated up to 4.5 years for reporting.

Closest Location

Research Site - Nashville, TN

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female
Aged at least 18 years
Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
No prior chemotherapy or radiotherapy for cervical cancer
WHO/ECOG performance status of 0-1
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is uterine cervical neoplasms?

Add answer

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.

Unverified Answer

What are common treatments for uterine cervical neoplasms?

Add answer

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.

Unverified Answer

How many people get uterine cervical neoplasms a year in the United States?

Add answer

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.

Unverified Answer

What causes uterine cervical neoplasms?

Add answer

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.

Unverified Answer

What are the signs of uterine cervical neoplasms?

Add answer

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.

Unverified Answer

Can uterine cervical neoplasms be cured?

Add answer

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.

Unverified Answer

Who should consider clinical trials for uterine cervical neoplasms?

Add answer

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.

Unverified Answer

What is the latest research for uterine cervical neoplasms?

Add answer

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.

Unverified Answer

Have there been any new discoveries for treating uterine cervical neoplasms?

Add answer

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.

Unverified Answer

What is durvalumab?

Add answer

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.

Unverified Answer

Does durvalumab improve quality of life for those with uterine cervical neoplasms?

Add answer

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.

Unverified Answer

How serious can uterine cervical neoplasms be?

Add answer

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.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Uterine Cervical Neoplasms by sharing your contact details with the study coordinator.