This phase Ib trial tests the safety, side effects and effectiveness of palbociclib combined with pembrolizumab in treating patients with sarcomas that has spread to nearby tissue or lymph nodes (locally advanced), or to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Sarcoma is a type of cancer that usually forms in the soft tissues but it may also form in the bone. It can occur anywhere in the body, but it usually occurs in the legs, arms, or abdomen and often grows quickly and spreads to other parts of the body, including the lungs. Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Pembrolizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Palbociclib given with pembrolizumab may be safe, tolerable, and/or effective in treating patients with locally advanced, metastatic or unresectable sarcomas.
Additional locations may be listed on ClinicalTrials.gov for NCT06113809.
Locations matching your search criteria
United States
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer CenterStatus: Active
Contact: John Markus Rieth
Phone: 319-356-1616
PRIMARY OBJECTIVE:
I. To confirm the safety of the CDK4/6 inhibitor palbociclib in combination with the anti-PD- 1 immunotherapy pembrolizumab in patients with sarcomas for which PD-1 inhibitors are approved as a safety lead-in using standard dosing of each drug.
SECONDARY OBJECTIVES:
I. To assess the response (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria) of patients with advanced sarcomas for which PD-1 inhibitors are approved with the combination of CDK4/6 inhibitor and anti-PD-1 immunotherapy.
II. To assess the progression free survival (PFS) at 6 months of patients with advanced sarcomas for which PD-1 inhibitors are approved with the combination of CDK4/6 inhibitor and anti-PD-1 immunotherapy.
III. To determine the immune modulating or priming effects of palbociclib as assessed by multiplex
immunohistochemical (IHC) analyses of immune cell infiltrates and global transcriptome analyses
by ribonucleic acid sequence (RNA-seq) in biopsies following treatment with combination therapy.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21 of cycles 1-3 and pembrolizumab intravenously (IV) over 30 minutes on day 15 of cycle 1, day 8 of cycle 2, and day 1 of subsequent cycles. Cycles repeat every 28 days on cycles 1 and 2 and every 21 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound guided biopsy at baseline, cycle 1 day 15, and cycle 3 day 1. Patients additionally undergo blood sample collection and computed tomography (CT) scans or magnetic resonance imaging (MRI) throughout study.
After completion of study treatment, patients are followed up for 6 months for up to 2 years.
Lead OrganizationUniversity of Iowa/Holden Comprehensive Cancer Center
Principal InvestigatorJohn Markus Rieth
