OncoMatch/Clinical Trials/NCT06113809
Palbociclib and Pembrolizumab in Sarcoma
Is NCT06113809 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Palbociclib and Pembrolizumab for sarcoma.
Treatment: Palbociclib · Pembrolizumab — This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib in patients with soft tissue sarcomas for which PD-1 inhibitors are approved (includes undifferentiated pleomorphic sarcoma, myxofibrosarcoma, angiosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, or alveolar soft part sarcoma).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Lab requirements
Blood counts
Neutrophil count >= 1000/mm3; Platelet count >= 100,000/mm3; Hemoglobin >= 9 g/dL (transfusion to meet eligibility allowed)
Kidney function
Serum creatinine <= 1.5x ULN or 24-hour creatinine clearance >= 30 mL/min per Cockroft-Gault equation; Subjects requiring hemodialysis excluded
Liver function
AST/SGOT and ALT/SGPT <= 3.0x ULN without disease involvement or <= 5.0x ULN if due to disease involvement; Alkaline phosphatase <= 5.0x ULN without known bony metastases; Serum bilirubin <= 1.5x ULN; Patients with severe hepatic impairment (Childs-Pugh Class C) excluded
Cardiac function
History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to Day 1 excluded
Lab values in the below ranges: Neutrophil count < 1000/mm3; Platelet count < 100,000/mm3; Hemoglobin < 9 g/dL (transfusion to meet eligibility allowed); AST/SGOT and ALT/SGPT > 3.0x ULN without disease involvement or > 5.0x ULN if the transaminase elevation is due to disease involvement; Alkaline phosphatase > 5.0x ULN without known bony metastases; Serum bilirubin > 1.5x ULN; Serum creatinine > 1.5x ULN or 24-hour creatinine clearance < 30 mL/min per Cockroft-Gault equation; Total serum calcium < lower limit of normal (LLN) or if calcium is below LLN the corrected calcium for serum albumin is > LLN; Serum potassium < 3.0; Serum sodium < 130; Serum albumin < 2.5 g/dL; History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to Day 1; Subjects requiring hemodialysis; Patients with severe hepatic impairment (Childs-Pugh Class C).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Iowa Hospitals & Clinics · Iowa City, Iowa
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06113809 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages