Pembrolizumab for Colorectal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorectal Carcinoma+5 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug in combination with radiation therapy. Researchers want to see if it is safe and effective in treating colorectal cancer that has spread to the liver.

Eligible Conditions
  • Colorectal Carcinoma
  • Liver

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 6 years

1 year
Expression levels of PDL1
Magnetic Resonance Imaging
Recurrence rate at 1 year
Tumor-infiltrating lymphocytes
up to 6 years
Disease-free survival estimated using the Kaplan-Meier method
Overall survival estimated using the Kaplan-Meier method
Time to recurrence estimated using the Kaplan-Meier method

Trial Safety

Trial Design

1 Treatment Group

SBRT + Pembrolizumab
1 of 1

Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1

SBRT + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, Stereotactic body radiotherapy (SBRT) · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Stereotactic body radiotherapy (SBRT)
2015
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,656 Previous Clinical Trials
4,954,140 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,061 Previous Clinical Trials
2,563,791 Total Patients Enrolled
Dustin DemingPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Able to understand the information provided Informed consent/assent is a process through which a person voluntarily agrees to participate in a study after being given a full explanation of the study
The person has a cancer that has spread to the liver and no other parts of the body.
This text is saying that microsatellite instability testing must be either MSI-stable or MSI-low.
Participants must have at least one intrahepatic lesion in order to be eligible for SBRT
The participant must be a surgical candidate who is looking to have all of their known diseases eradicated with one additional surgery
If a person had surgery to remove extra-hepatic metastatic disease more than a year ago and now new extra-hepatic disease has been found, they are allowed to participate in the study.
You must be at least 18 years old in order to sign this form.
The tumor must be proficient in mismatch repair, as determined by microsatellite instability or immunohistochemistry for MMR proteins.
To ensure accurate results, IHC for MMR proteins must demonstrate the presence of intact MMR proteins.
Histologic confirmation of a colorectal primary tumor is acceptable if accompanied by radiographic evidence of metastatic disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.