Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT02888665|
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : November 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Doxorubicin Hydrochloride Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 1 Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Pembrolizumab in Combination With Doxorubicin as Treatment for Patients With Advanced Sarcomas|
|Actual Study Start Date :||December 5, 2016|
|Estimated Primary Completion Date :||August 1, 2019|
Experimental: Treatment (pembrolizumab, doxorubicin hydrochloride)
Patients receive pembrolizumab 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.
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose of doxorubicin hydrochloride together with pembrolizumab according to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: Up to 42 days (6 weeks) ]Defined as a dose limiting toxicity in less than 2 of 6 patients.
- Objective response rate (ORR) (Phase II) [ Time Frame: Up to 2 years ]Will compare ORR with historical rates.
- Duration of response [ Time Frame: Up to 2 years ]
- Incidence of adverse events, according to NCI CTCAE version 4.0 [ Time Frame: Up to 2 years ]
- Median progression-free survival (PFS) [ Time Frame: Up to 2 years ]The Kaplan-Meier method will be used to estimate median PFS.
- Overall survival (OS) [ Time Frame: Up to 2 years ]The Kaplan-Meier method will be used to estimate median OS.
- Time to response [ Time Frame: Up to 2 years ]
- Expression of PD-L1 [ Time Frame: At baseline ]To evaluate the association between PD-L1 expression and clinical outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888665
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Seth Pollack 206-667-6629 email@example.com|
|Principal Investigator: Seth Pollack|
|Principal Investigator:||Seth Pollack||Fred Hutch/University of Washington Cancer Consortium|