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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be >= 18 years of age

Pleomorphic sarcoma with inflammation or with limited areas of differentiation

Pleomorphic sarcoma with giant cells

Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Diagnostic Imaging Testing

    Procedure/Surgery

    Undergo standard imaging scans

  • Doxorubicin

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo ECHO

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Pembrolizumab

    Biological/Vaccine

    Given IV

Treatment groups

365 Participants
are divided into 2 treatment groups
Group A: Arm A (doxorubicin and pembrolizumabExperimental treatment 6 interventions
Group B: Arm B (doxorubicin)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

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). Will be analyzed separately for the undifferentiated pleomorphic sarcoma and related malignancies and for the dedifferentiated liposarcoma.

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

Secondary outcomes

1

Overall survival

Will be compared between doxorubicin + pembrolizumab vs doxorubicin alone to test the strategy of upfront pembrolizumab vs second line pembrolizumab.

Time frame
From randomization to death, up to 5 years

Other outcomes

1

Progression status

Evaluated using Cohen's kappa coefficient.

Time frame
From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years
2

Progression time

Time frame
From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years

Sponsors and contacts

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