Pembrolizumab for Fast-Growing Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether pembrolizumab (also known as MK-3475), a cancer treatment, is safe and effective for individuals with fast-growing cancers that are microsatellite stable but have a high tumor mutation rate. Researchers aim to determine if this drug can reduce tumor size and help manage the disease. It suits patients whose cancer has progressed despite previous treatments and who have a measurable tumor with specific genetic traits. Participants will receive close monitoring to ensure the treatment's safety and effectiveness. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from cutting-edge therapy.
Will I have to stop taking my current medications?
The trial requires that you stop certain medications before starting. You must not have had chemotherapy, biological cancer therapy, or radiation within 2 weeks before the first dose. Also, you cannot use systemic corticosteroids or certain immunotherapies within one week before starting the study drug.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that pembrolizumab, the treatment under study, has been used in many cancer trials. One analysis reviewed over ten thousand reports of side effects from these trials. The most common issues included tiredness, pain, rash, diarrhea, fever, cough, and loss of appetite. These side effects are generally manageable, meaning they can be treated or controlled.
Another study found that combining pembrolizumab with chemotherapy for certain stomach cancers improved survival and response rates. It also had a safety profile considered manageable, indicating that while side effects can occur, they are usually not severe enough to outweigh the potential benefits for many patients.
In summary, pembrolizumab has been widely studied and is usually well-tolerated, but like any treatment, it can have side effects.12345Why do researchers think this study treatment might be promising?
Pembrolizumab, known by its study name MK-3475, is unique because it targets the PD-1 pathway, which is a mechanism that allows cancer cells to hide from the immune system. Unlike standard chemotherapy, which directly attacks rapidly dividing cells, pembrolizumab enhances the body's own immune response to fight cancer, offering a potentially more targeted and less toxic approach. Researchers are excited about this treatment because it could provide a new option for patients with fast-growing tumors that are microsatellite instability (MSI) negative, a group that often lacks effective treatment alternatives.
What evidence suggests that pembrolizumab might be an effective treatment for fast-growing cancers?
Research has shown that pembrolizumab, also known as MK-3475, effectively treats various types of cancer by helping the immune system identify and attack cancer cells. Studies have found that pembrolizumab can extend survival and generally causes fewer severe side effects compared to some other treatments. For instance, in patients with advanced bladder cancer, some experienced complete responses, with their cancer becoming undetectable. While pembrolizumab is typically used for tumors with specific genetic features, this trial will examine its effectiveness in cancers without these features, specifically in the MSI (Microsatellite Unstable) Negative with Mutator Phenotype arm.16789
Who Is on the Research Team?
Dung Le, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Are You a Good Fit for This Trial?
This trial is for patients with microsatellite stable tumors and high tumor mutation burden (>20 mutations/MB). They must have received prior cancer therapy, be in good physical condition (ECOG 0-1), have proper organ function, agree to use birth control, consent to biopsies, and not have certain health issues or recent treatments that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-3475 (pembrolizumab) to evaluate anti-tumor activity and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-3475
Trial Overview
The trial tests MK-3475 (pembrolizumab) effectiveness and safety in patients whose cancers are MSI-negative but show a mutator phenotype. It aims to see if this drug can shrink or slow the growth of these specific types of tumors.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Pembrolizumab - StatPearls - NCBI Bookshelf - NIH
Pembrolizumab is a medication used in the management and treatment of various oncologic conditions. It is in the cancer immunotherapy class of drugs.
Pembrolizumab as Second-Line Therapy for Advanced ...
Pembrolizumab was associated with significantly longer overall survival (by approximately 3 months) and with a lower rate of treatment-related adverse events ...
3.
researchgate.net
researchgate.net/publication/314029035_Pembrolizumab_Pembro_MK-3475_for_advanced_urothelial_cancer_Results_of_a_phase_IB_studyMK-3475) for advanced urothelial cancer: Results of a ...
Three out of 29 (10%) were complete responders and four (14%) achieved a PR; PFS was 8-9 weeks and median OS was 9.3 months [59, 60] . Currently ...
4.
targetedonc.com
targetedonc.com/view/pembrolizumab-mk-3475-combination-to-be-evaluated-in-prostate-cancerPembrolizumab Combination to be Evaluated in Prostate ...
In April 2013, pembrolizumab received a breakthrough therapy designation from the FDA for the treatment of patients with advanced melanoma ...
Efficacy of pembrolizumab in microsatellite-stable, tumor ...
Pembrolizumab showed significantly shorter survival than FTD/TPI (±bevacizumab) in later-line treatment of MSS-TMB-H mCRC. •. Comprehensive genomic profiling ...
Retrospective analysis of clinical trial safety data for ...
We analyzed over ten thousand adverse event reports from Keynote clinical trials of pembrolizumab for various cancer indications with or without co-occurring ...
Side Effects of KEYTRUDA® (pembrolizumab)
Common side effects of KEYTRUDA when used alone include feeling tired; pain, including pain in muscles; rash; diarrhea; fever; cough; decreased appetite; ...
Efficacy and safety of pembrolizumab in advanced gastric and ...
Pembrolizumab combined with chemotherapy improves survival and response rates with a manageable safety profile in advanced gastric and GEJ cancers.
FDA Approves Merck's KEYTRUDA® (pembrolizumab) for ...
The safety profile observed in patients with MSI-H or dMMR tumors was consistent with previously reported safety data. For KEYTRUDA, the most common adverse ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.