NCT02888665

Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery

A Trial of Pembrolizumab in Combination With Doxorubicin as Treatment for Patients With Advanced Sarcomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of doxorubicin hydrochloride when given together with pembrolizumab and to see how well they work in treating patients with sarcoma that have spread to other parts of the body or that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride together with pembrolizumab may work better in treating patients with sarcoma.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of the combination of pembrolizumab and doxorubicin hydrochloride (doxorubicin) in patients with advanced soft tissue sarcoma (STS). II. To assess the clinical response rate of advanced soft tissue sarcoma (STS) patients receiving the combination of pembrolizumab and doxorubicin. SECONDARY OBJECTIVES: I. To explore the clinical activity of pembrolizumab in subjects with advanced STS with respect to time to response. II. To explore the clinical activity of pembrolizumab in subjects with advanced STS with respect to duration of response. III. To explore the clinical activity of pembrolizumab in subjects with advanced STS with respect to progression-free survival (PFS). IV. To explore the clinical activity of pembrolizumab in subjects with advanced STS with respect to overall survival. TERTIARY OBJECTIVES: I. To compare response rates between patients with high levels of PD-L1 expression with those who have PD-L1 absent. OUTLINE: This is a phase I, dose-escalation study of doxorubicin hydrochloride followed by a phase II study. Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Doxorubicin Hydrochloride	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2016-12-05
• Primary completion: 2020-03-17
• Completion: 2020-10-09
• First posted: 2016-09-05
• Last updated: 2021-05-26
• Results posted: 2021-05-26

Locations

1 site across 1 country: United States