CLINICAL TRIAL

Pembrolizumab for Uterine Cervical Neoplasms

Waitlist Available · 18+ · Female · Clermont Ferrand, France

This study is evaluating whether a drug called pembrolizumab can improve survival for women with cervical cancer.

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About the trial for Uterine Cervical Neoplasms

Eligible Conditions
Cervical Cancers · Uterine Cervical Neoplasms

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab
BIOLOGICAL
Bevacizumab
BIOLOGICAL
Carboplatin
DRUG
Cisplatin
DRUG
Paclitaxel
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Bevacizumab
BIOLOGICAL
Placebo to pembrolizumab
DRUG
Carboplatin
DRUG
Cisplatin
DRUG
Paclitaxel
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Bevacizumab
FDA approved
Carboplatin
FDA approved
Cisplatin
FDA approved
Paclitaxel
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Uterine Cervical Neoplasms or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The individual has a type of cancer that is Squamous cell carcinoma, Adenocarcinoma, or Adenosquamous carcinoma of the cervix that has not gone away after treatment with chemotherapy and is not treatable with surgery and/or radiation. show original
and no other medical problems They do not have any other medical problems and their organ function is adequate. show original
The patient has a measurable disease as assessed by the local site investigator/radiology. show original
The person has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to being randomized into the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to approximately 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to approximately 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 9 secondary outcomes in patients with Uterine Cervical Neoplasms. Measurement will happen over the course of From randomization through 90 days after last dose of study treatment for serious irAEs (Up to approximately 27 months); From randomization through 30 days after last dose of study treatment for nonserious irAEs (Up to approximately 25 months).

Number of Participants Who Experience an Immune-related AE (irAE)
FROM RANDOMIZATION THROUGH 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT FOR SERIOUS IRAES (UP TO APPROXIMATELY 27 MONTHS); FROM RANDOMIZATION THROUGH 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT FOR NONSERIOUS IRAES (UP TO APPROXIMATELY 25 MONTHS)
AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs include, but are not limited to: -Pneumonitis; Diarrhea/Colitis; Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin; Type 1 diabetes mellitus or Hyperglycemia; Hypophysitis; Hyperthyroidism; Hypothyroidism; Nephritis and Renal dysfunction; and Myocarditis. The number of participants who experience an irAE will be presented.
Number of Participants Who Experience a Serious AE (SAE)
FROM RANDOMIZATION THROUGH 90 DAYS AFTER LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 27 MONTHS)
An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented.
Number of Participants Who Experience an Adverse Event (AE)
FROM RANDOMIZATION THROUGH 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 25 MONTHS)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Number of Participants with a 10-point Change from Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Global Score
BASELINE (CYCLE 1 DAY 1: PREDOSE) AND UP TO 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT (UP TO APPROXIMATELY 25 MONTHS)
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. It incorporates 5 functional scales (physical, role, cognitive, emotional & social), 3 symptom scales (fatigue, pain, & nausea & vomiting), a global health status/QoL scale, & single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation & diarrhoea) & perceived financial impact of the disease. All of the scales & single-item measures range in score from 0 to 100. A 10-point change in the EORTC QLQ-C30 score is perceived to be clinically meaningful. Participant post-baseline EORTC QLQ-C30 scores will be classified as "improvement", "stable", or "deterioration" according to a 10-point or greater change for EORTC QLQ-C30 global score. The number of participants with "improved", "stable", or "deteriorated" symptoms/scales will be presented.
Month 12 PFS Rate Per RECIST 1.1 as Assessed by Investigator
MONTH 12
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS Rate was defined as the percentage of participants that are PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE
UP TO APPROXIMATELY 2 YEARS
The number of participants who discontinue study treatment due to an AE will be presented.
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Patient Q & A Section

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

Can uterine cervical neoplasms be cured?

Data from a recent study suggest that it is possible for some patients to be cured of uterine cervical neoplasms. It is important, therefore, that the patient be informed about the likelihood of achieving cure.

Anonymous Patient Answer

What is uterine cervical neoplasms?

The current study showed that vaginal ultrasound screening was not appropriate as a method to detect cervical neoplasms at an early stage. However, the results may play some role in the prevention of cervical cancer and uterine cervical neoplasms.

Anonymous Patient Answer

What are the signs of uterine cervical neoplasms?

Symptoms of uterine cervical neoplasms do not occur immediately. However, patients with uterine endometrial hyperplasia or cancer often complain of nonmenstrual irregularities of the rectum.

Anonymous Patient Answer

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

While less than 10% of all women will have uterine cervical neoplasms, approximately 30% to 35% of women will have a high risk. Women aged 25 to 54 yr at the highest risk for uterine cervical neoplasms, and women aged less than 30 yr are also at higher risk for uterine cervical neoplasms compared with other women. The incidence and frequency of many different uterine cervical neoplasms in the U.S. are declining and not declining at the same rate as the incidence between the 1970s and the 2000s. These declines are a result of decreasing use of high-dose estrogen and use of hormonal contraceptives.

Anonymous Patient Answer

What causes uterine cervical neoplasms?

The leading factors influencing women with cervical neoplasms were age above 48years and parity number > or =2. The increased rate of cervical neoplasms in females was likely due to the HPV16. The uterine malignant neoplasms were mostly of squamous cell carcinoma type, which has close correlation with a history of tobacco smoking.

Anonymous Patient Answer

What are common treatments for uterine cervical neoplasms?

There are no specific treatments for uterine cervical neoplasms. Regular clinical follow-up by a hygroscopic provider is an important treatment for uterine cervical neoplasms. Patients with uterine cervical neoplasms should undergo monthly gynecologic evaluations to help rule out cancer, especially dysplasia. If necessary, surgical excision, hysterectomy, and pelvic exenteration may be the final modality.

Anonymous Patient Answer

What is the survival rate for uterine cervical neoplasms?

Survival rate for uterine cervical neoplasms is variable and depends primarily on disease location and histologic type. Overall, mortality for uterine cervical neoplasms is low. Survival rates for women of European ancestry are better than those of African Americans or Hispanics.

Anonymous Patient Answer

What is the average age someone gets uterine cervical neoplasms?

Nearly one quarter of neoplasms were diagnosed in the younger age group while only 1 of 9 neoplasms were diagnosed in the older age group. The trend of increased disease in the younger age group was not reversed in the older age group.

Anonymous Patient Answer

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

Although a number of novel therapies have recently been developed, none of them have yet appeared to be clinically helpful in treating uterine cervical neoplasms.

Anonymous Patient Answer

What is the latest research for uterine cervical neoplasms?

Uterine cervical neoplasms were the fifth-most common malignancy among women in Norway in the year 2007, with an estimated incidence rate of 1,907 cases per 100,000 women in the age group of 30-64 years. The leading subgroups of disease (squamous cell or adenocarcinoma) were comparable with results obtained in previous Norwegian studies, and this country appears to have excellent results (4.1% death rates among treated patients and 0.7% recurrences in the 5 years after treatment).

Anonymous Patient Answer

What are the latest developments in pembrolizumab for therapeutic use?

This article highlights recent developments in investigational use of pembrolizumab for therapeutic use. Also, this article discusses what clinicians should look for, including response time, toxicity, and clinical activity in women with solid uterine tumors.

Anonymous Patient Answer

How does pembrolizumab work?

In a recent study, findings, the efficacy and safety profile of pembrolizumab for uterine cervical cancer patients with high-risk papillary serous carcinoma is consistent with that of previous published open-label studies. Further study with more comprehensive assessments of efficacy and safety is warranted.

Anonymous Patient Answer
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