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

NCT05694871 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: A092107NCI-2022-08568
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 194

Brief 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

Locally Advanced Dedifferentiated Liposarcoma; 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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Efficacy analyses will be based on intention to treat principles. PFS will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio, median PFS, and estimated PFS rates at 12, 24, 36, and 48 months will be estimated along with corresponding 95% confidence intervals. A log-rank test will be used to compare the PFS distributions between the two treatment arms in this cohort. Cox proportional hazards models will also be used to assess the impact of treatment arm on PFS when stratifying on the stratification factors.

  The time from randomization to the first documentation of disease progression or death, assessed up to 48 months.

Secondary Outcomes (4)

• Incidence of adverse events

  Up to 2 years

• Duration of response (DoR)

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Progression free rate at 8 weeks (PFR8)

  At 8 weeks

Other Outcomes (4)

• CDK4 copy number

  Up to 2 years

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

  Up to 2 years

• Relationship between CDK4 copy number and the tumor immune microenvironment and clinical outcomes

  up to 2 years

Study Arms (2)

Arm I (palbociclib)

ACTIVE COMPARATOR

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.

Drug: Palbociclib; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Biospecimen collection; Other: Questionnaire Administration

Arm II (palbociclib, cemiplimab)

EXPERIMENTAL

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.

Drug: Palbociclib; Biological: Cemiplimab; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Biospecimen collection; Other: Questionnaire Administration

Interventions

Palbociclib DRUG

Given PO

Also known as: PD-0332991

Arm I (palbociclib); Arm II (palbociclib, cemiplimab)

Cemiplimab BIOLOGICAL

Given IV

Also known as: Cemiplimab RWLC, Immunoglobulin G4

Arm II (palbociclib, cemiplimab)

Magnetic Resonance Imaging PROCEDURE

undergo MRI

Also known as: MRI

Arm I (palbociclib); Arm II (palbociclib, cemiplimab)

Computed Tomography PROCEDURE

Undergo a CT Scan

Also known as: CAT Scan, CT Scan

Arm I (palbociclib); Arm II (palbociclib, cemiplimab)

Biospecimen collection PROCEDURE

Undergo blood sample collection

Arm I (palbociclib); Arm II (palbociclib, cemiplimab)

Questionnaire Administration OTHER

Ancillary Studies

Arm I (palbociclib); Arm II (palbociclib, cemiplimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (194)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, 93420, United States

Location

Mercy Cancer Center - Carmichael

Carmichael, California, 95608, United States

Location

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Kaiser Permanente Dublin

Dublin, California, 94568, United States

Location

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758, United States

Location

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

Location

Fresno Cancer Center

Fresno, California, 93720, United States

Location

Kaiser Permanente-Fresno

Fresno, California, 93720, United States

Location

Mercy Cancer Center

Merced, California, 95340, United States

Location

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

Location

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Mercy Cancer Center - Rocklin

Rocklin, California, 95765, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States

Location

Mercy Cancer Center - Sacramento

Sacramento, California, 95816, United States

Location

South Sacramento Cancer Center

Sacramento, California, 95823, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, 93401, United States

Location

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, 93444, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Woodland Memorial Hospital

Woodland, California, 95695, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

Location

Saint Francis Cancer Center

Colorado Springs, Colorado, 80923, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Mercy Medical Center

Durango, Colorado, 81301, United States

Location

Southwest Oncology PC

Durango, Colorado, 81301, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Littleton Adventist Hospital

Littleton, Colorado, 80122, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

Parker Adventist Hospital

Parker, Colorado, 80138, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

SIH Cancer Institute

Carterville, Illinois, 62918, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

Location

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

Location

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

Location

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

Location

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

Location

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

Location

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

Location

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States

Location

Alegent Health Mercy Hospital

Council Bluffs, Iowa, 51503, United States

Location

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, 51503, United States

Location

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, 51503, United States

Location

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Council Bluffs, Iowa, 51503, United States

Location

Flaget Memorial Hospital

Bardstown, Kentucky, 40004, United States

Location

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, 40701, United States

Location

Saint Joseph Hospital

Lexington, Kentucky, 40504, United States

Location

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, 40504, United States

Location

Saint Joseph Hospital East

Lexington, Kentucky, 40509, United States

Location

Saint Joseph London

London, Kentucky, 40741, United States

Location

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, 40353, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

Location

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

Location

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

Location

CHI Health Good Samaritan

Kearney, Nebraska, 68847, United States

Location

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, 68114, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Oncology Associates PC

Omaha, Nebraska, 68114, United States

Location

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

Location

Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Alegent Health Lakeside Hospital

Omaha, Nebraska, 68130, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Midlands Community Hospital

Papillion, Nebraska, 68046, United States

Location

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210, United States

Location

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011, United States

Location

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

Location

Geauga Hospital

Chardon, Ohio, 44024, United States

Location

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

TriHealth Cancer Institute-Westside

Cincinnati, Ohio, 45247, United States

Location

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio, 45255, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23229, United States

Location

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Saint Michael Cancer Center

Silverdale, Washington, 98383, United States

Location

West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, 54729, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, 53548, United States

Location

Marshfield Medical Center - Ladysmith

Ladysmith, Wisconsin, 54848, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States

Location

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

Location

Marshfield Medical Center - Neillsville

Neillsville, Wisconsin, 54456, United States

Location

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

ThedaCare Cancer Care - Waupaca

Waupaca, Wisconsin, 54981, United States

Location

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States

Location

MeSH Terms

Conditions

Liposarcoma

Interventions

palbociclib; cemiplimab; Immunoglobulin G; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: June 7, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (194)