NCT03056001

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

A Pilot Study Evaluating the Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to assess the safety and toxicity profile of doxorubicin and pembrolizumab in previously treated or untreated subjects with unresectable or metastatic soft tissue sarcoma. The secondary objectives are to assess overall survival, and response rate, duration of response, and progression-free survival (PFS) with this regimen using RECIST 1.1 criteria. The exploratory objectives are to assess PFS, overall response rate, duration of response, and disease control rate using the immune-related RECIST (irRECIST) criteria, evaluate the correlation between PD-L1 expression levels and antitumor activity of MK-3475, investigate other biomarkers that may correlate with tumor responses, and evaluate differences in tumor tissue characteristics in biopsies taken during or post-treatment with MK-3475 versus baseline.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-11-16
• Completion: 2022-11-15
• First posted: 2017-02-16
• Last updated: 2023-11-18
• Results posted: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study