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

NCT05694871 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

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

Interventions

DRUG

Palbociclib

Given PO

BIOLOGICAL

Cemiplimab

Given IV

PROCEDURE

Magnetic Resonance Imaging

undergo MRI

PROCEDURE

Computed Tomography

Undergo a CT Scan

PROCEDURE

Biospecimen collection

Undergo blood sample collection

OTHER

Questionnaire Administration

Ancillary Studies

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694871 on ClinicalTrials.gov