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Monoclonal Antibodies
Pre-Surgery Pembrolizumab for Solid Cancers
Phase 2
Waitlist Available
Led By Michael J Overman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of solid cancer
Locally advanced cancer defined as either an unresectable primary cancer or a resectable primary cancer with a high chance of recurrence (defined as an estimated greater or equal to 20% chance of recurrence by the treating physician). A resectable primary may include locoregional disease, as long as all disease is felt by the treating physician to be in a resectable distribution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying how well pembrolizumab works before surgery in treating patients with MSI-H or dMMR solid cancers.
Who is the study for?
Adults with locally advanced solid cancers that are mismatch repair deficient (dMMR) or have high microsatellite instability (MSI-H). Participants must be in good health otherwise, with specific blood counts and liver function within acceptable ranges. They should not be pregnant or breastfeeding and willing to use contraception if necessary. Those who've had recent major surgery, immunodeficiency, HIV, other cancer treatments within 2 weeks, severe allergies to pembrolizumab, active infections or autoimmune diseases requiring treatment in the last 2 years cannot join.Check my eligibility
What is being tested?
The trial is testing how well pembrolizumab works when given before surgery to patients with certain types of advanced solid tumors. Pembrolizumab is an immunotherapy drug designed to help the immune system detect and fight cancer cells by blocking a pathway known as PD-1/PD-L1.See study design
What are the potential side effects?
Pembrolizumab may cause side effects like fatigue, skin reactions, diarrhea, hormonal gland problems (like thyroid dysfunction), inflammation-related symptoms affecting lungs or intestines; it can also weaken the immune system making one prone to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a confirmed diagnosis of solid cancer.
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My cancer is advanced but hasn't spread far and doctors think it might come back after surgery.
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My cancer shows a specific genetic change related to how it repairs DNA.
Select...
My cancer has specific genetic features known as dMMR or MSI-H.
Select...
My cancer has high microsatellite instability.
Select...
My kidney function is within the required range for the study.
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My liver function tests are within the required range.
Select...
My cancer is MSI-H as determined by a specific genetic test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological complete response (pCR)
Secondary outcome measures
Incidence of adverse events
Overall survival
Rate of organ sparing
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not respond to pembrolizumab and stop the treatment after 2 doses may undergo surgery within 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,767 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,607 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
283 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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