Pembrolizumab for Soft Tissue Sarcoma (STS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA
Soft Tissue Sarcoma (STS)+1 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a single-arm clinical trial determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery.

Eligible Conditions

  • Soft Tissue Sarcoma (STS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Soft Tissue Sarcoma (STS)

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 3 years

Up to 3 years
Duration of response
Feasibility, measured as the number of patients completing at least one cycle of pembrolizumab and completion of SBRT
Local failure at the irradiated site
Overall survival
Up to 3 years.
Number of grade 3-5 adverse events
Overall response rate (ORR) at non-irradiated sites
Patient reported health-related quality of life
Patient reported toxicity
Patient reported treatment satisfaction
Progression-free survival

Trial Safety

Safety Progress

1 of 3

Other trials for Soft Tissue Sarcoma (STS)

Trial Design

1 Treatment Group

Pembrolizumab + SBRT
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase < 1

Pembrolizumab + SBRTExperimental Group · 2 Interventions: Stereotactic body radiation therapy, Pembrolizumab · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiation therapy
2017
Completed Phase 1
~30
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: Chao Family Comprehensive Cancer Center, University of California, Irvine · Orange, CA
Photo of Orange 1Photo of Orange 2Photo of Orange 3
2011First Recorded Clinical Trial
1 TrialsResearching Soft Tissue Sarcoma (STS)
4 CompletedClinical Trials

Who is running the clinical trial?

University of California, IrvineLead Sponsor
486 Previous Clinical Trials
1,874,288 Total Patients Enrolled
Jeremy Harris, MD, MPhilPrincipal InvestigatorUniversity of California, Irvine

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have histologically or cytologically confirmed soft-tissue sarcoma, or a soft-tissue sarcoma with tumor mutational burden ≥10 mut/Mb.
You do not have a disease amenable to curative intent surgery.
You are eligible for this trial if you are a male or female, of all races and ethnic groups, and if you are aged 18 years or older.
You have an adequate organ and marrow function as defined below.
You have a performance status of 2 or less.
This study is evaluating whether radiation therapy combined with a cancer drug may help treat a rare type of cancer in children.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.