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
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