Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

Conditions

• Metastatic Dedifferentiated Liposarcoma
• Metastatic Undifferentiated Pleomorphic Sarcoma
• Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Unresectable Dedifferentiated Liposarcoma
• Unresectable Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Diagnostic Imaging Testing — PROCEDURE
  Undergo standard imaging scans
• Doxorubicin — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA scan
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Sep 11, 2024

Status verified

May 2026

Primary completion

Jun 30, 2035

Completion

Jun 30, 2035

Study Design

Enrollment

365 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (doxorubicin and pembrolizumab
  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.
• Active Comparator: Arm B (doxorubicin)
  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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 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 ]

Locations (245)

Find similar trials in Phoenix, AZ

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