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PD-1 Inhibitor

Cemiplimab + Palbociclib for Liposarcoma

Phase 2

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a combo of drugs can help treat advanced liposarcoma better than one drug alone.

Who is the study for?

Adults with advanced dedifferentiated liposarcoma that's spread and can't be removed by surgery. They must have good organ function, no severe heart disease or active infections, and not be pregnant or nursing. People with certain autoimmune diseases or those needing high-dose steroids are excluded.

What is being tested?

The trial is testing if adding Cemiplimab to Palbociclib improves treatment outcomes for advanced liposarcoma compared to Palbociclib alone. Participants will either receive the combination therapy or just Palbociclib, and their cancer's response will be monitored.

What are the potential side effects?

Possible side effects include immune system reactions, fatigue, digestive issues, skin problems like rash, liver enzyme changes, blood cell count variations which could increase infection risk. Specific side effects from each drug may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Duration of response (DoR)

Incidence of adverse events

Overall survival (OS)

+1 more

Other study objectives

CDK4 copy number

Efficacy and toxicity endpoints

Infiltrating immune cell subsets and tumor and immune cell major histocompatibility complex (MHC) and PD-L1 expression

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (palbociclib, cemiplimab)Experimental Treatment6 Interventions

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.

Group II: Arm I (palbociclib)Active Control5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Biospecimen collection

2020

N/A

~130