Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
Run by Alliance for Clinical Trials in Oncology · NCT05694871 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2028-04-07.
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 adva…
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 77 (actual) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | Palbociclib, Cemiplimab, Magnetic Resonance Imaging, Computed Tomography, Biospecimen collection, Questionnaire Administration |
| Locations | 194 sites (United States) |
| Trial ID | NCT05694871 on ClinicalTrials.gov |
What this trial studies
PRIMARY OBJECTIVES: I. To perform a safety lead-in among 6 patients to confirm that the combination of palbociclib and cemiplimab is safe and tolerable. II. To evaluate whether palbociclib in combination with cemiplimab (Arm 2) demonstrates a superior progression-free survival (PFS) compared to palbociclib monotherapy (Arm 1) for patients with advanced dedifferentiated liposarcoma (DDLPS). SECONDARY OBJECTIVES: I. To evaluate the toxicity profile in and across each treatment arm as determined by both Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO)-CTCAE criteria. II. To evaluate and compare the objective response rate (ORR) and duration of response (DOR) in and across each treatment arm. III. To evaluate and compare the overall survival (OS) in and across each treatment arm. IV. To evaluate and compare progression-free rate at 12 weeks (PFR12) in and across each treatment arm. EXPLORATORY OBJECTIVES: I. To collect genomic sequencing data previously collected as standard of care, including data on CDK4 copy number (as determined by fluorescence in situ hybridization \[FISH\] or other molecular testing). II. To conduct multiplex immunohistochemistry using archival tumor tissue (where available) to define densities of infiltrating immune cell subsets and tumor and immune cell major histocompatibility complex (MHC) and PD-L1 expression. III. To perform an exploratory analysis to evaluate for any relationship between CDK4 copy …
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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): 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 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 must be able to swallow oral medications * 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) * 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) * 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 * 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
Where it's running
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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
Show 44 more locations
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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
+144 more sites. See ClinicalTrials.gov for the full list.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.