OncoMatch/Clinical Trials/NCT06113809
Palbociclib and Pembrolizumab in Sarcoma
Is NCT06113809 recruiting? Yes, currently enrolling (May 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
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
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 →
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