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Pre-Surgery Pembrolizumab for Solid Cancers
Study Summary
This trial is studying how well pembrolizumab works before surgery in treating patients with MSI-H or dMMR solid cancers.
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 am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.I have fully recovered from any major surgery before starting the study treatment.I am 18 or older with a confirmed diagnosis of solid cancer.My cancer is advanced but hasn't spread far and doctors think it might come back after surgery.My hemoglobin level is above 8.0 g/dL without blood transfusions or erythropoietin in the last 2 weeks.My cancer shows a specific genetic change related to how it repairs DNA.I had radiotherapy over 2 weeks ago, with no ongoing side effects and didn't need steroids.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My cancer has specific genetic features known as dMMR or MSI-H.I've had cancer treatment within the last 2 weeks and have recovered from side effects.You are not able to become pregnant OR you are a woman who can become pregnant and agree to use birth control during the study and for at least 120 days after the study ends. This is to avoid any harm to a potential fetus.I am currently being treated for an infection.My cancer has spread to distant parts of my body, not just nearby lymph nodes.I have another cancer besides the one being studied, but it's not getting worse or treated in the last year.I have not received a live vaccine in the last 30 days.I have had or currently have lung inflammation treated with steroids.You have mental health or drug/alcohol problems that might make it difficult for you to follow the trial's requirements.You (or your legal representative) have given written permission to participate in the trial.You are currently using or have used an experimental medication or device in the last 4 weeks before starting this study. If you have completed a previous experimental study, you need to wait at least 4 weeks before starting this one.My cancer has high microsatellite instability.My kidney function is within the required range for the study.I am fully active or restricted in physically strenuous activity but can do light work.My liver function tests are within the required range.I have been treated with specific immune therapy drugs before.My cancer is MSI-H as determined by a specific genetic test.I have or can provide samples of my tumor for testing.You have a tumor that can be measured using standard criteria.My blood clotting tests are within normal limits, or if on blood thinners, within the therapeutic range.
- Group 1: Treatment (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
How many participants are actively engaged in this clinical experiment?
"Affirmative. Clinicaltrials.gov data shows that the recruitment for this medical trial, which was opened on September 17th 2019, is still open and actively seeking participants. 35 patients need to be enrolled from a single location."
Has the regulatory agency given authorization for Pembrolizumab?
"Data has only been collected on Pembrolizumab's safety, so we have assigned it a score of 2."
Have there been other investigations utilizing Pembrolizumab?
"Currently, Pembrolizumab has 961 active clinical trials running worldwide, 122 of which are in the third stage. Houston is a major hub for this medication research with around 35 thousand locations conducting tests on it."
What are the overarching aims of this medical study?
"The primary objective of this research, evaluated over a 12 month period, is to assess the pathological complete response (pCR) rate. Secondary objectives include tracking adverse events using Common Terminology Criteria for Adverse Events toxicity and post-operative complications classified with Clavien-Dindo's framework; additionally, organ sparing rates amongst those receiving at least 3 doses of neoadjuvant pembrolizumab will be considered. Finally, relapse-free survival data determined by Kaplan and Meier's methodology shall also be obtained."
For what conditions is Pembrolizumab typically prescribed?
"Pembrolizumab is regularly administered to patients suffering from malignant neoplasms, and can also be beneficial in treating microsatellite instability high, unresectable melanoma, and cancer that has progressed following chemotherapy."
Are there still opportunities to partake in this investigation?
"This medical trial is currently recruiting participants, as noted on the clinicaltrials.gov website. It was initially listed on September 17th 2019 and has most recently been amended in March 2022."
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