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ACTIVE NOT RECRUITING

NCT05694871

PHASE2

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Official title: Official Title A Randomized Phase 2 Trial With a Safety Lead-In to Evaluate Palbociclib Versus Palbociclib and Cemiplimab for the Treatment of Advanced Dedifferentiated Liposarcoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-06-07

Completion Date

2027-05-31

Last Updated

2026-01-26

Healthy Volunteers

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

Inclusion Criteria: * ELIGIBILITY CRITERIA (STEP 1): Patients must have histologically documented dedifferentiated liposarcoma (DDLPS). Patients with mixed well-differentiated/dedifferentiated liposarcoma (WD/DD LPS) tumors are eligible provided there is a histologically confirmed DDLPS component at some point during the treatment course * Disease must be metastatic or locally advanced and surgically unresectable, in the opinion of the treating investigator * Note: Intact retinoblastoma protein (RB) can be assumed in DDLPS. In a query of project Genomics Evidence Neoplasia Information Exchange (GENIE) (American Association for Cancer Research \[AACR\]), including 286 DDLPS tumors, the rate of RB1 mutation in DDLPS was 1.37%. Therefore, molecular testing to determine intact Rb is not required * ELIGIBILITY CRITERIA (STEP 1): Patients must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria to be eligible for this study. Previously radiated lesions should not be used as target lesions unless there is documented evidence of disease progression of that lesion after radiation * ELIGIBILITY CRITERIA (STEP 1): Patients may have received any number of prior systemic treatment lines for DDLPS, including none * ELIGIBILITY CRITERIA (STEP 1): Patients must have recovered to baseline or =\< grade 1 per CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy, and with the exceptions of fatigue (which must be =\< grade 2), alopecia and/or endocrinopathies related to prior immunotherapy which are controlled with hormone replacement * ELIGIBILITY CRITERIA (STEP 1): Patients must have completed all prior anti-cancer treatment, including radiation, \>= 14 days prior to registration * ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years * ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * ELIGIBILITY CRITERIA (STEP 1): Absolute neutrophil count (ANC) \>= 1000/mm\^3 * ELIGIBILITY CRITERIA (STEP 1): Platelet count \>= 100,000/mm\^3 * ELIGIBILITY CRITERIA (STEP 1): Hemoglobin \>= 9 g/dL * ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance (CrCl) \>= 30 mL/min * ELIGIBILITY CRITERIA (STEP 1): Total bilirubin =\< 1.5 x upper limit of normal (ULN) * ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN * ELIGIBILITY CRITERIA (STEP 1): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible, patients should be class IIB or better. Furthermore, patients may not have an uncontrolled ventricular arrhythmia or recent (within 3 months) myocardial infarction * ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently receiving treatment, they are eligible if they have an undetectable HCV viral load * ELIGIBILITY CRITERIA (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients participating on this trial may not be receiving other anti-neoplastic therapies and there should be no anticipated need for such therapy * ELIGIBILITY CRITERIA (STEP 1): Patients with treated brain metastases that are non-progressing are eligible if follow-up brain imaging performed at least 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are not eligible * ELIGIBILITY CRITERIA (STEP 1): Patients must be able to swallow oral medications * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): In order to cross over to Arm 2, patients must meet the same eligibility criteria as described above * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Patients must have demonstrated progression of disease on palbociclib monotherapy (Arm 1) per RECIST version 1.1 criteria Exclusion Criteria: * ELIGIBILITY CRITERIA (STEP 1): Patients may not have received prior treatment with CDK4/6 inhibitors (including, but not limited to: palbociclib, ribociclib or abemaciclib) or anti-PD-1/anti-PD-L1 antibodies * ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \* Therefore, for women of childbearing potential only, a negative serum pregnancy test done =\< 7 days prior to registration is required * ELIGIBILITY CRITERIA (STEP 1): Patients must not have an active autoimmune disease with the exception of vitiligo, well-controlled asthma or allergic rhinitis, type 1 diabetes, psoriasis or hypothyroidism. Patients with a history of adrenal insufficiency are eligible if on a stable dose of prednisone =\< 10 mg or equivalent * ELIGIBILITY CRITERIA (STEP 1): Patients must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any other condition that would limit compliance with study requirements * ELIGIBILITY CRITERIA (STEP 1): Patients may not require the use of chronic steroids in excess of 10 mg prednisone daily or equivalent * ELIGIBILITY CRITERIA (STEP 1): Patients may not require concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir). The required washout period prior to re-registration 2 weeks * ELIGIBILITY CRITERIA (STEP 1): Patients may not require concomitant use of known strong CYP3A inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort). The required washout period prior to re-registration is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Patients may not have experienced a grade 3 or higher non-hematologic adverse event deemed clinically significant in the opinion of the treating investigator, or have discontinued palbociclib due to toxicity, while participating on Arm 1 * Patients must also have recovered to baseline or =\< grade 1 per CTCAE version 5.0 from toxicity related to Arm 1 treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy, and with the exceptions of fatigue (which must be =\< grade 2), alopecia and/or endocrinopathies related to prior immunotherapy which are controlled with hormone replacement * Note: Patients who underwent dose reduction of palbociclib during treatment on Arm 1 will begin treatment on Arm 2 at the same dose (i.e. dose re-escalation is not allowed) * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Patients may not have received prior treatment with anti-PD-1/anti-PD-L1 antibodies * RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \* Therefore, for women of childbearing potential only, a negative serum pregnancy test done =\< 7 days prior to re-registration is required

Locations (194)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Mercy Cancer Center

Merced, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Southwest Oncology PC

Durango, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Parker Adventist Hospital

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Alegent Health Mercy Hospital

Council Bluffs, Iowa, United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Council Bluffs, Iowa, United States

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Saint Joseph Hospital

Lexington, Kentucky, United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Saint Joseph Hospital East

Lexington, Kentucky, United States

Saint Joseph London

London, Kentucky, United States

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

CHI Health Good Samaritan

Kearney, Nebraska, United States

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC