A Randomized Phase III Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas
ClinicalTrials.gov processed this data on December 6, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified September 2024 by National Cancer Institute (NCI)
Sponsor
National Cancer Institute (NCI)Information Provided by (Responsible Party)
National Cancer Institute (NCI)Clinicaltrials.gov Identifier
NCT06422806Other Study ID Numbers: NCI-2023-06412
First Submitted: May 18, 2024
First Posted: May 21, 2024
Last Update Posted: December 9, 2024
Last Verified: September 2024
History of Changes
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Study Description
PRIMARY OBJECTIVE:I. To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.
KEY SECONDARY OBJECTIVE:
I. To assess whether the combination of doxorubicin and pembrolizumab versus (vs) the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS).
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability in each treatment arm. II. To quantify overall response rate (ORR) and durability of response (DOR) in each treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive doxorubicin intravenously (IV) over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity.
Patients in both arms also undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan, standard imaging scans and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months in years 2-10.
Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 180 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Randomized Phase III Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas |
Study Start Date | September 11, 2024 |
Anticipated Primary Completion Date | June 30, 2026 |
Anticipated Study Completion Date | June 30, 2026 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) [From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors version 1.1) or death from any cause without prior progression, up to 5 years] Will be compared between the treatment arms (doxorubicin + pembrolizumab versus [vs] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group performance status [0 vs 1]) log-rank test with a 2.5% type I error (1-sided).
Secondary Outcome Measures
- Overall survival [From randomization to death, up to 5 years] Will be compared between doxorubicin + pembrolizumab vs doxorubicin alone to test the strategy of upfront pembrolizumab vs second line pembrolizumab.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | National Cancer Institute (NCI) |
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Locations |
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Investigators |
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More Information
Additional Relevant MeSH Terms
- Sarcoma
- Histiocytoma, Malignant Fibrous
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Histiocytoma
- Neoplasms, Fibrous Tissue
- Neoplasms, Connective Tissue