Pembrolizumab for Fast-Growing Cancers

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Immunotherapy, Corticosteroids, Growth factors, others

Disqualifiers: Autoimmune disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be looking at whether MK-3475 (pembrolizumab) is effective (anti-tumor activity) and safe in patients with MSI (Microsatellite Unstable) negative cancer with a mutator phenotype.

Research Team

Dung Le, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

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

I have colon cancer and have undergone at least two treatments.

My tumor is stable and has a high number of mutations.

I have had at least one treatment for my cancer.

Exclusion Criteria

Patients with history of allogeneic hematopoeitic stem cell transplant

I have not received a live vaccine within 4 weeks around my MK-3475 dose, except for the flu shot.

I have not had major surgery in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-3475 (pembrolizumab) to evaluate anti-tumor activity and safety

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

56 months

Treatment Details

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.

Participant Groups

Group I: MSI (Microsatellite Unstable) Negative with Mutator Phenotype Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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