At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Confirmed histopathologic diagnosis of DDLPS, UPS, or related poorly differentiated sarcoma
- ✓Metastatic or unresectable sarcoma
- ✓LVEF >50% by MUGA or echocardiogram within 28 days
- ✕Pregnant or breast-feeding
- ✕Prior anthracycline treatment
- ✕Active or progressive brain metastases requiring immediate CNS treatment, per physician judgment
- ✕Clinically significant immunodeficiency or autoimmune disorder requiring chronic systemic steroids or steroids within 7 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Dedifferentiated Liposarcoma (DDLPS), Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas
In Brief
A Phase 3 clinical trial evaluating Biospecimen Collection, Diagnostic Imaging Testing, and 4 other interventions for Metastatic Dedifferentiated Liposarcoma and 5 related conditions. Currently recruiting, targeting 365 participants across 256 sites in 3 countries.
Signals
Detailed Summary
This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.
Study Details
Timeline
Arms & Interventions
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. 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. Patients also undergo ECHO or MUGA scan, standard imaging scans and blood sample collection throughout the study.
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 also undergo ECHO or MUGA scan, standard imaging scans and blood sample collection throughout the study.
Interventions
Undergo blood sample collection
Undergo standard imaging scans
Given IV
Undergo ECHO
Undergo MUGA scan
Given IV