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A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity

NCT03092323 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-11-18

No results posted yet for this study

Summary

This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.

Conditions

  • Soft Tissue Sarcoma of the Extremity

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm.

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Sarcoma Alliance for Research through Collaboration

    lead OTHER

Principal Investigators

  • David Kirsch, MD, PhD · Princess Margaret Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2025-09-01
Completion
2028-09-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092323 on ClinicalTrials.gov