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Pembrolizumab for Endometrial Cancer
Study Summary
This trial is testing the effects of the immunotherapy drug pembrolizumab on patients with endometrial cancer that has spread or come back and has an ultra-mutated or hyper-mutated phenotype. The study will look at the proportion of patients whose tumors shrink with pembrolizumab, the side effects of the drug, and how long patients live without their disease progressing or coming back.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have previously been treated with specific immunotherapy drugs.You have not used any experimental drugs or devices within the last four weeks before starting the trial.My tumor is highly mutated according to specific genetic tests.I have recovered from recent cancer treatments, but I may still have some nerve pain or damage.I am 18 years old or older.You are pregnant or breastfeeding.I do not have current severe digestive system problems.I have an autoimmune disease that affects my organs or requires steroids.I've had chemotherapy with radiation to enhance its effect.I have had pneumonitis treated with steroids or have it now.I haven't had active cancer treatment in the last 5 years, except for certain skin cancers or cervical cancer.I am not pregnant and agree to use birth control during and after treatment.I have recovered from recent cancer treatments, but I may have moderate nerve pain or damage.I have stopped any hormonal treatments for endometrial cancer at least a week ago.My cancer is one of the specified types of epithelial cell cancers.I have completed any radiation therapy for endometrial cancer at least 4 weeks ago.I stopped my endometrial cancer treatment 3 weeks ago, or any trial drugs 30 days ago.My brain metastases are treated, stable, and I haven't taken high-dose steroids recently.I have tested positive for HIV, AIDS, hepatitis B, or hepatitis C.I can perform all my usual activities without assistance.I am currently receiving IV treatment for an infection.It has been over 4 weeks since my major surgery.I have stopped all cancer treatments 3 weeks ago, and any trial drugs 30 days ago.I may have had up to 4 treatments for my condition.I have recovered from side effects of previous treatments, except for mild neuropathy or hair loss.I completed radiation for endometrial cancer over 4 weeks ago.I have been cancer-free for at least 3 years, except for skin or in situ cervical cancers.I am fully active or can carry out light work.I am not pregnant and agree to use birth control during and after treatment.My tumor is highly mutated due to specific genetic changes.My cancer is one of the specified types of epithelial cell cancer.I stopped my hormonal therapy for endometrial cancer at least a week ago.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I have not received a live vaccine within the last 30 days.I have an active tuberculosis infection.My organs are functioning well enough to start treatment.My endometrial cancer has returned or worsened after chemotherapy.My endometrial cancer has come back or worsened after chemotherapy.You must have a disease that can be measured using a specific medical evaluation method called RECIST 1.1.
- Group 1: Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Pembrolizumab been given the green light by the FDA?
"This drug has been safety tested and, as such is rated a 2 on the 1 to 3 scale. However, there are not yet any efficacy data available for Pembrolizumab."
Are there any available slots still open for this trial?
"According to clinicaltrials.gov, this medical investigation is not currently accepting new patients; however, the initial posting date was September 1st 2016 and updates were made as recently as May 11th 2022. Despite this study's inactivity, 1246 other studies are actively seeking participants at present."
Is this evaluation of treatments open to elderly individuals?
"As per the requirements of this research, prospective participants must be older than 18 but not exceed 100 years old."
What other exploratory trials have been conducted using Pembrolizumab?
"Currently, there are 961 trials exploring Pembrolizumab and 122 of them have reached Phase 3. Houston, Texas hosts many of these studies but the medication is being investigated in 35727 distinct locations throughout the world."
Who is eligible for enrollment in this research project?
"This clinical trial is searching for 25 individuals with endometrial neoplasms who are aged 18 to 100. Desired participants should meet the following criteria: biopsy-confirmed recurrent or progressive endometrial cancer after at least one prior chemotherapy regimen, negative urine and serum pregnancy test taken within 72 hours before receiving first dose of Pembrolizumab, discontinued all therapy (including chemo/targeted therapies) 3 weeks prior to study date, eligible tumor histologies include Endometrioid adenocarcinoma, serous adenocarcinoma, clear cell carcinoma etc., RECIST 1.1 measurable"
In what ways has Pembrolizumab traditionally been utilized?
"Pembrolizumab is widely utilised to treat malignant neoplasms, as well as unresectable melanoma, microsatellite instability-high tumors and conditions exhibiting post-chemotherapy progression."
What is the headcount of participants currently accepted into this research endeavor?
"Recruitment for this trial is finished. The study, which was first published on September 1st 2016 and last modified on May 11th 2022, no longer needs new participants. Alternatively, there are currently 285 clinical trials open to those with endometrial neoplasms and 961 studies involving Pembrolizumab that remain actively recruiting patients."
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