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Checkpoint Inhibitor

Pembrolizumab for Endometrial Cancer

Phase 2
Waitlist Available
Led By Alessandro D. Santin, M.D
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumors must demonstrate ultramutation (POLE/POLD1-mutation) and/or hyper-mutation (due to MMR gene defect) in a representative primary or metastatic tumor site by next generation sequencing (NGS) and Comprehensive Genomic Profiling (CGP) testing, and/or standard PCR-based DNA microsatellite instability (MSI) and immunohistochemistry (IHC).
Recovered from effects of recent surgery, radiotherapy, or chemotherapy; ≥ Grade 2 neuropathy eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with endometrial cancer that has returned or spread after chemotherapy. Participants must have a certain type of genetic change in their tumors, be in good physical condition (ECOG 0-1), and have recovered from previous treatments. Women who can bear children must agree to use contraception and not be pregnant.Check my eligibility
What is being tested?
The trial tests Pembrolizumab's effectiveness on patients with ultramutated or hypermutated endometrial cancer by measuring tumor response rates and monitoring the drug's safety profile. It also aims to estimate how long patients live without disease progression and overall survival time.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs, skin reactions, hormone gland problems (like thyroid dysfunction), fatigue, infusion reactions, and possibly increase the risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is highly mutated according to specific genetic tests.
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I have recovered from recent cancer treatments, but I may still have some nerve pain or damage.
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I am 18 years old or older.
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I am not pregnant and agree to use birth control during and after treatment.
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I have recovered from recent cancer treatments, but I may have moderate nerve pain or damage.
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I have completed any radiation therapy for endometrial cancer at least 4 weeks ago.
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I have stopped any hormonal treatments for endometrial cancer at least a week ago.
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My cancer is one of the specified types of epithelial cell cancers.
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I've had chemotherapy with radiation to enhance its effect.
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I can perform all my usual activities without assistance.
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I have stopped all cancer treatments 3 weeks ago, and any trial drugs 30 days ago.
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I am fully active or can carry out light work.
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My tumor is highly mutated due to specific genetic changes.
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My cancer is one of the specified types of epithelial cell cancer.
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My endometrial cancer has returned or worsened after chemotherapy.
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My endometrial cancer has come back or worsened after chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of adverse events as assessed by CTCAE v4
Neoplasms
Secondary outcome measures
Duration of progression-free survival (PFS)
Overall survival (OS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab 200 mg, Q3W, IV Infusion, Day 1 of each 3 week cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,388 Total Patients Enrolled
3 Trials studying Endometrial Cancer
92 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,675 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,143 Patients Enrolled for Endometrial Cancer
Alessandro D. Santin, M.DPrincipal InvestigatorYale University

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02899793 — Phase 2
Endometrial Cancer Research Study Groups: Pembrolizumab
Endometrial Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02899793 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02899793 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025