Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT03338959|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Recurrent Soft Tissue Sarcoma||Biological: Pembrolizumab Radiation: Radiation Therapy||Phase 1 Phase 2|
I. To determine the rate of complete histopathologic necrosis following the combination of pembrolizumab and neoadjuvant radiation.
I. To determine response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria following the combination of radiation and pembrolizumab.
II. To confirm the tolerability and safety of the combination of neoadjuvant pembrolizumab and radiation in a population with localized soft tissue sarcoma (STS) based on Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Patients receive pembrolizumab intravenously (IV) per institutional standard at the Seattle Cancer Care Alliance as an outpatient therapy. Cycles repeat every 3 weeks, up to a maximum of three doses, for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks beginning on Day 1 of Week 2.
After completion of study treatment, patients are followed up at 30 days after last dose, 90 days after last dose, 30 days after post-operative visit (wound care follow-up), and then every 12 weeks for up to 1 year, then every 6 months up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Pembrolizumab and Neoadjuvant Radiation for Large, High-Risk Soft Tissue Sarcomas|
|Actual Study Start Date :||March 28, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Treatment (pembrolizumab, radiation therapy)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks.
Radiation: Radiation Therapy
Undergo radiation therapy
- Rate of complete tumor necrosis [ Time Frame: From baseline through wound care follow-up visit (up to 8 months) ]Percentage of the tumor that has undergone necrosis.
- Incidence of adverse events [ Time Frame: Through the wound care follow-up visit (up to 8 months) ]Evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
- Partial Response Rate [ Time Frame: From baseline through wound care follow-up visit (up to 8 months) ]Proportion of patients who achieved a partial response (≥30% decrease in the sum of the longest diameters of target tumors) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338959
|Contact: Roxanne Mooreemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Roxanne Moore 206-606-6425 firstname.lastname@example.org|
|Principal Investigator: Seth M. Pollack|
|Principal Investigator:||Seth Pollack||Fred Hutch/University of Washington Cancer Consortium|