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PD-1 Inhibitor

Arm II (palbociclib, cemiplimab) 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Duration of response (DoR)

Incidence of adverse events

Overall survival (OS)

+1 more

Other outcome measures

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

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

Biospecimen collection

2020

N/A

~70

Computed Tomography

2017

Completed Phase 2

~2720

Palbociclib

2017

Completed Phase 3

~3760

Cemiplimab

2015

Completed Phase 3

~1340

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,566 Total Patients Enrolled

1 Trials studying Liposarcoma

15 Patients Enrolled for Liposarcoma

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,369 Total Patients Enrolled

28 Trials studying Liposarcoma

2,071 Patients Enrolled for Liposarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants still being enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov data shows that this research, which was initially posted on May 30th 2023, is currently seeking participants. 38 sites have been identified and 72 patients must be recruited in total."

Answered by AI

What are the potential risks associated with Arm II (palbociclib, cemiplimab) for patients?

"Although the data supporting efficacy is limited, there is still evidence to suggest Arm II (palbociclib, cemiplimab) can be safely administered. As such, our team has given it a rating of 2 on a scale from 1 to 3."

Answered by AI

What is the current capacity of this medical examination?

"Affirmative, the data hosted on clinicaltrials.gov suggests that this research project is actively recruiting participants. This trial was initially posted on May 30th 2023 and has since been revised as recently as July 20th of the same year. In total, 72 patients need to be enrolled from 38 different healthcare facilities."

Answered by AI

Is the clinical trial for this research prevalent in North America?

"Currently, 38 clinical trial sites are actively admitting patients for the study. Locations include Bellevue, Highland Park and Council Bluffs in addition to 35 other places of research. To reduce travel demands during participation, it is urged that you choose the closest site available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05694871.

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