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Alkylating agents
Pembrolizumab + Chemotherapy for Endometrial Cancer
Phase 3
Waitlist Available
Led By Ramez N Eskander
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
Performance status of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying the combination of pembrolizumab, paclitaxel, and carboplatin to treat endometrial cancer.
Who is the study for?
This trial is for adults with stage III-IV or recurrent endometrial cancer. Eligible participants may have had prior hormonal therapy, but not chemotherapy for this cancer within the last year, and no previous treatment with certain immunotherapy drugs. They must not be pregnant, agree to use contraception if of childbearing potential, and cannot have severe allergies to the study drugs or significant health conditions that could affect safety.Check my eligibility
What is being tested?
The trial tests adding pembrolizumab (an immunotherapy drug) to the usual chemotherapy regimen of paclitaxel and carboplatin in treating advanced or recurrent endometrial cancer. It aims to see if this combination improves outcomes compared to chemotherapy alone.See study design
What are the potential side effects?
Pembrolizumab can cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), and infusion-related reactions. Chemotherapy with paclitaxel and carboplatin may lead to hair loss, nausea, fatigue, increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer is at stage III, IVA, IVB, or is recurrent.
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I can take care of myself and perform daily activities.
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My endometrial cancer is at stage III, IVA, IVB, or is recurrent.
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My cancer's type has been confirmed by a pathology report.
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My cancer can be measured by scans and has a visible tumor or enlarged lymph node.
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I cannot have surgery to reduce my tumor size after starting this trial until my disease progresses.
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I cannot have surgery to reduce my tumor after starting this trial until my disease progresses.
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My pathology report includes MMR protein testing results.
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I am 18 years old or older.
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My cancer type is confirmed and matches one of the specified types.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Association between PD-L1 IHC and MMR status
Concordance between Institutional Mismatch repair (MMR) immunohistochemistry (IHC) testing and centralized MMR IHC
Duration of objective response
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (pembrolizumab, paclitaxel, carboplatin)Experimental Treatment6 Interventions
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan throughout the study.
Group II: Arm I (placebo, paclitaxel, carboplatin)Active Control6 Interventions
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan throughout the study.
On February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm 1 will not receive additional placebo infusions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
66,694 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,093 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,932,908 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hepatitis B virus load is undetectable with treatment.I have not taken steroids or immunosuppressants in the last 7 days.My endometrial cancer is at stage III, IVA, IVB, or is recurrent.I am HIV positive, on treatment, and my viral load is undetectable.I must provide a tumor sample for specific testing before the next trial phase.I do not have any severe illnesses that could interfere with the study.You have received a pathology report that shows the results of a specific type of testing for certain proteins.I have had pneumonitis treated with steroids or have it now.I have completed any radiation therapy for endometrial cancer at least 4 weeks ago.Your absolute neutrophil count is at least 1,500 per microliter.I have another cancer, but it won't affect this cancer treatment's safety or results.I have completed any radiation therapy for endometrial cancer at least 4 weeks ago.Your AST and ALT levels are not more than three times the upper limit of normal.I am taking mineralocorticoids for low blood pressure or adrenal gland issues.I haven't had chemotherapy for endometrial cancer, or it's been over a year since I completed it.Your bilirubin level in your blood should not be too high, unless you have a condition called Gilbert's disease.I do not have significant liver disease like hepatitis or cirrhosis.I have stopped any hormonal treatments for endometrial cancer at least 3 weeks ago.I can take care of myself and perform daily activities.Your platelet count is at least 100,000 per microliter.I am not currently in a cancer study or haven't been in one for the last 4 weeks.I have stopped any hormonal therapy for endometrial cancer at least 3 weeks ago.I have vitiligo, type I diabetes, or thyroid issues treated with hormones.My endometrial cancer is at stage III, IVA, IVB, or is recurrent.My cancer's type has been confirmed by a pathology report.I have another cancer type, but it won't affect this trial's treatment.I am using inhaled or topical corticosteroids.I have or had an autoimmune disease that could worsen or needs steroids.My cancer can be measured by scans and has a visible tumor or enlarged lymph node.I cannot have surgery to reduce my tumor size after starting this trial until my disease progresses.I have been treated with specific immune therapy drugs before.You have had a serious allergic reaction to a specific type of medication called a monoclonal antibody, or to paclitaxel and carboplatin.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I cannot have surgery to reduce my tumor after starting this trial until my disease progresses.Your thyroid stimulating hormone (TSH) levels are normal, and if they are not, your Free T4 level should be normal too.My pathology report includes MMR protein testing results.My brain cancer hasn't worsened after treatment, and I've been off steroids for 4 weeks.I am 18 years old or older.My cancer type is confirmed and matches one of the specified types.I have taken steroids for CT scan contrast.I may need to use corticosteroids for my condition, pending approval.If you have rheumatoid arthritis, Sjogren's syndrome, or psoriasis, it's okay if you're using topical medications to control them. If you have certain positive blood tests, we'll need to check if it's affecting your organs before you can join.Your creatinine level is not higher than the normal range for the lab's standards.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (pembrolizumab, paclitaxel, carboplatin)
- Group 2: Arm I (placebo, paclitaxel, carboplatin)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the more common reasons that doctors prescribe Pembrolizumab?
"Pembrolizumab is frequently used to ameliorate malignant neoplasms but can also be useful for treating other conditions, such as unresectable melanoma, microsatellite instability high, and patients with a high risk of recurrence."
Answered by AI
What other experimental treatments have included Pembrolizumab?
"Pembrolizumab was first trialed in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been a total of 1990 completed trials. Right now, 2077 studies are actively recruiting patients with many clinical sites based in Danbury, Connecticut."
Answered by AI
How many research centers are coordinating this trial?
"Danbury Hospital in Danbury, Connecticut, Northwest Oncology LLC in Dyer, Indiana, and Ascension Saint Vincent Indianapolis Hospital in Indianapolis are all participating locations for this clinical trial. 100 other medical facilities are also included."
Answered by AI
Has Pembrolizumab been cleared by the FDA for public use?
"Pembrolizumab is a Phase 3 trial drug, so it has received a safety rating of 3 from our Power team. This score takes into account both efficacy data and multiple rounds of safety testing."
Answered by AI
How many test subjects are part of this research?
"Yes, as indicated by the clinicaltrials.gov website, this research is actively recruiting participants. This trial was originally posted on July 16th, 2019 and updated November 16th, 2020. They are hoping to enroll 810 individuals from 100 different locations."
Answered by AI
Are there any current openings for participants in this trial?
"That is accurate. According to clinicaltrials.gov, this trial began recruiting patients on 7/16/2019 and is still looking for 810 more across 100 sites. The data was last updated on 11/16/2022."
Answered by AI
Who else is applying?
What state do they live in?
District of Columbia
New York
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Lowell General Hospital
New York-Presbyterian/Brooklyn Methodist Hospital
The Moncton Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
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