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Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab for Sarcoma

NCT03056001 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-18

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment.

Conditions

  • Soft Tissue Sarcoma, Adult
  • Soft Tissue Sarcoma, Child

Interventions

DRUG

Pembrolizumab

IV infusion on day 1 of each 3 week cycle, at dose of 200 mg

DRUG

Doxorubicin

IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)

Sponsors & Collaborators

Principal Investigators

  • Megan Jagosky, MD · Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2021-11-16
Completion
2022-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03056001 on ClinicalTrials.gov