A Randomized Phase 2 Trial with a Safety Lead-In to Evaluate Palbociclib Versus Palbociclib and Cemiplimab for the Treatment of Advanced Dedifferentiated Liposarcoma
Categories (click each to see list of all clinical trials associated with that category): Sarcoma (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Abughanimeh, Omar
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05694871?term=NCT05694871&draw=2&rank=1#eligibility
Summary
2.1 Primary objective(s)
2.1.1 To perform a safety lead-in among 6 patients to confirm that the combination of palbociclib and cemiplimab is safe and tolerable.
2.1.2 To evaluate whether palbociclib in combination with cemiplimab (Arm 2) demonstrates a superior PFS compared to palbociclib monotherapy (Arm 1) for patients with advanced DDLPS.
2.2 Secondary objective(s)
2.2.1 To evaluate the toxicity profile in and across each treatment arm as determined by both CTCAE and PRO-CTCAE criteria.
2.2.2 To evaluate and compare the objective response rate (ORR) and duration of response (DOR) in and across each treatment arm.
2.2.3 To evaluate and compare the overall survival (OS) in and across each treatment arm.
2.2.4 To evaluate and compare progression-free rate at 8 weeks (PFR8) in and across each treatment arm.
2.3 Exploratory objectives
2.3.1 To collect genomic sequencing data previously collected as standard of care, including data on CDK4 copy number (as determined by FISH or other molecular testing).
2.3.2 To conduct multiplex immunohistochemistry using archival tumor tissue (where available) to define densities of infiltrating immune cell subsets and tumor and immune cell MHC and PD-L1 expression.
2.3.3 To perform an exploratory analysis to evaluate for any relationship between CDK4 copy number and (a) the tumor immune microenvironment as defined by multiplex immunohistochemistry and (b) clinical outcomes from study treatment.
2.3.4 To explore efficacy and toxicity endpoints, including PFS and ORR, for patients who progress on palbociclib monotherapy and crossover to the palbociclib plus cemiplimab combination.