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

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05694871

Provider View

This study is comparing the effects of using palbociclib alone versus combining it with cemiplimab to treat advanced dedifferentiated liposarcoma, a type of cancer that may have spread. The goal is to see if the combination is more effective in controlling the cancer.

Patient Parameters

Program Overview

This phase II trial is investigating whether adding cemiplimab to palbociclib can better control advanced dedifferentiated liposarcoma, a cancer that may have spread to other parts of the body. Palbociclib works by blocking enzymes that help cancer cells grow, while cemiplimab is an antibody that may stop cancer cells from growing and spreading. The study aims to find out if this combination can shrink or stabilize the cancer more effectively than palbociclib alone.

Description

The main goals of this study are to ensure the safety of combining palbociclib and cemiplimab and to see if this combination can help patients live longer without the cancer getting worse compared to using palbociclib alone.

Secondary goals include checking the side effects of each treatment, comparing how well the cancer responds to each treatment, and seeing how long patients live overall. The study will also look at how the cancer behaves at 8 weeks into treatment.

Researchers will collect genetic information from previous tests and analyze tumor samples to understand the immune response and how it relates to treatment outcomes. They will also explore what happens if patients switch from palbociclib alone to the combination treatment after the cancer progresses.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will take palbociclib by mouth. If the cancer progresses, they can switch to the combination treatment. Patients will have regular MRI or CT scans and may give blood samples.

  • Group 2: Patients will take palbociclib by mouth and receive cemiplimab through an IV. They will also have regular MRI or CT scans and may give blood samples.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS).
  • Cancer must be advanced, spread, or cannot be removed by surgery.
  • Must have at least one measurable tumor.
  • Can have had any number of previous treatments for DDLPS.
  • Must have recovered from any side effects of previous treatments.
  • Must be 18 years or older.
  • Must be in good general health (ECOG status 0-2).
  • Must have adequate blood cell counts and organ function.
  • Must not have serious heart conditions.
  • Must have controlled hepatitis B or C, if applicable.
  • Must be HIV negative or have controlled HIV.
  • Must not have other cancers that interfere with this study.
  • Must not have active brain metastases.
  • Must be able to swallow pills.
  • If switching to the combination treatment, must meet the same criteria and have shown cancer progression on palbociclib alone.

Exclusion Criteria

  • Must not have had previous treatment with CDK4/6 inhibitors or anti-PD-1/PD-L1 antibodies.
  • Must not be pregnant or breastfeeding.
  • Must not have active autoimmune diseases, except for certain controlled conditions.
  • Must not have uncontrolled illnesses or require high doses of steroids.
  • Must not be taking certain medications that interact with the study drugs.
  • If switching to the combination treatment, must not have had severe side effects from palbociclib alone and must not have had previous treatment with anti-PD-1/PD-L1 antibodies.

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