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 : Completed
First Posted : September 5, 2016
Results First Posted : May 26, 2021
Last Update Posted : May 26, 2021
|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)|
|Actual Enrollment :||37 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|
|Actual Primary Completion Date :||March 17, 2020|
|Actual Study Completion Date :||October 9, 2020|
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 (MTD) of Doxorubicin Hydrochloride Plus 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 (DLT) in less than 2 of 6 subjects. Only Phase 1 subjects will be evaluated for MTD.
- Objective Response Rate (ORR) (Phase II) [ Time Frame: Up to 2 years ]Evaluated per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT. Complete Response (CR) is a complete elimination of the tumor; Partial Response (PR) is 30% reduction. If a subject experienced a PR, this was required to be confirmed with a second scan at the next appropriate cycle.
- Duration of Response [ Time Frame: Up to 2 years ]Duration of response is the mean time to progression for all subjects who responded.
- 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 ]Average time to response
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|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Seth Pollack||Fred Hutch/University of Washington Cancer Consortium|