Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

Conditions

• Advanced Dedifferentiated Liposarcoma
• Locally Advanced Dedifferentiated Liposarcoma
• Metastatic Dedifferentiated Liposarcoma
• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Palbociclib — DRUG
  Given PO
• Cemiplimab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  undergo MRI
• Computed Tomography — PROCEDURE
  Undergo a CT Scan
• Biospecimen collection — PROCEDURE
  Undergo blood sample collection
• Questionnaire Administration — OTHER
  Ancillary Studies

Study Details

This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone.

Key Dates

Start date

Jun 7, 2023

Status verified

May 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

77 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (palbociclib)
  Patients receive palbociclib PO on study. Patients will be allowed to cross over to Arm II following documentation of disease progression. Patients undergo MRI or CT scans throughout the trial. Patients may also undergo blood sample collection on study.
• Experimental: Arm II (palbociclib, cemiplimab)
  Patients receive palbociclib PO and cemiplimab IV on study. Patients undergo MRI or a CT scan throughout the trial. Patients may also undergo blood sample collection on study.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: The time from randomization to the first documentation of disease progression or death, assessed up to 48 months. ]

Locations (194)

Find similar trials in Birmingham, AL

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