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PD-1 Inhibitor

Stereotactic body radiotherapy (SBRT) for Liver Metastases

Phase 1
Waitlist Available
Led By Dustin Deming
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

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
  • Liver Metastases
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence rate at 1 year
Secondary outcome measures
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
Other outcome measures
Expression levels of PDL1
Magnetic Resonance Imaging
Tumor-infiltrating lymphocytes

Trial Design

1Treatment groups
Experimental Treatment
Group I: SBRT + PembrolizumabExperimental Treatment2 Interventions
Subjects will receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment. Following SBRT, subjects will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery subjects will being the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab subjects will also have tumor imaging (CT or MRI).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy (SBRT)
2015
Completed Phase 1
~50
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,369 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,884 Previous Clinical Trials
5,054,367 Total Patients Enrolled
Dustin DemingPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer
2016. "PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02837263.
~2 spots leftby Apr 2025
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