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Pembrolizumab + Olaparib for Endometrial Cancer
Study Summary
This trial will test whether a combination of two drugs is an effective treatment for endometrial cancer or endometrial carcinosarcoma.
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 a significant liver condition.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I stopped my hormonal therapy for endometrial cancer at least a week ago.My endometrial cancer has come back or did not go away after treatment.I have been treated with drugs targeting PD-1, PD-L1, or CTLA-4.I am taking medication that strongly affects liver enzymes and cannot stop during the study.My endometrial cancer is either serous, carcinosarcoma, grade 3 endometrioid, or undifferentiated.I am not pregnant, not breastfeeding, and follow birth control advice.I am fully active or can carry out light work.I have been treated with lenvatinib or similar drugs along with anti-PD-1 or anti-PD-L1 therapy.I finished chemotherapy more than 3 weeks ago.My previous hormonal therapy does not count as a treatment.I have had 1 to 3 treatments for endometrial cancer.I am 18 years old or older.I have had pneumonitis treated with steroids or currently have it.I have another cancer that won't affect this treatment's safety or results.My brain cancer has worsened or I've been off steroids for less than 4 weeks.I have been treated for an autoimmune disease in the last 2 years.I do not have any uncontrolled illnesses.I cannot take pills by mouth or have stomach issues that affect medication absorption.I have not been in a cancer study or received experimental treatment in the last 4 weeks.I am highly allergic to pembrolizumab or olaparib.I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.I had radiotherapy less than 2 weeks before starting the study treatment.I am taking medication that strongly affects liver enzymes and cannot stop during the study.I have not received a live vaccine in the last 30 days.I have previously been treated with a PARP inhibitor.I am HIV-positive, on treatment, and my viral load is undetectable.
- Group 1: Pembrolizumab with Olaparib
- 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
Are there any unfilled slots for participants in this trial?
"Verified. According to clinicaltrials.gov, this medical study has initiated recruitment and is searching for 25 participants at 7 locations. It was posted on January 27th 2022 and its last update occurred on October 21st 2022."
What medical conditions have been found to be ameliorated by Pembrolizumab?
"Pembrolizumab is the go-to therapy for those with unresectable melanoma, as well as individuals facing a high risk of recurrence or microsatellite instability."
How many sites are engaged in this research endeavor?
"At present, 7 medical centres are contributing to this study. These sites include Middletown, Basking Ridge and Montvale as well as 4 other locations. To minimize any travel requirements, it is recommended that participants select the closest site to them for enrollment."
Is this a groundbreaking research endeavor?
"After AstraZeneca's initial research into pembrolizumab began in 2005, the drug was granted its Phase 1 approval. Nowadays, 1114 studies are underway for this medication at 3058 different locations and 66 countries."
To what extent has Pembrolizumab been tested in other scientific experiments?
"Currently, 1114 clinical trials are researching the efficacy of Pembrolizumab with 143 studies at Phase 3. Out of all the locations conducting these experiments, Houston Texas is a major hub - though there are 42751 operating sites around the world."
What is the enrollment capacity for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this trial is now open for enrollment and was initially published on January 27th 2022 with the most recent update occurring October 21st of that same year. 25 study participants are needed between 7 distinct medical centres."
What potential adverse reactions might one experience while using Pembrolizumab?
"The safety of pembrolizumab is estimated to be a 2, taking into account the findings of this Phase 2 trial. Although data confirming its efficacy has yet to emerge, there are studies that support its relative safeness."
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