Clinical Trials Logo

Clinical Trial Summary

This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib.


Clinical Trial Description

Patients will be given palbociclib for 2 weeks following a pre-treatment ultrasound guided biopsy used to establish immunological baseline of the tumor microenvironment. After 2 weeks of palbociclib therapy, a second biopsy will be performed to assess the impact of palbociclib on the tumor microenvironment. Pembrolizumab will be started the same day as the second biopsy. After 2 doses of pembrolizumab, a third (optional) biopsy may be performed if the subject consents. At 8 weeks of therapy disease response will be assessed as per standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06113809
Study type Interventional
Source University of Iowa
Contact Mohammed Milhem, MBBS
Phone (319) 356-2324
Email mohammed-milhem@uiowa.edu
Status Recruiting
Phase Phase 1
Start date February 1, 2024
Completion date July 2028

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Completed NCT02565758 - ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors Phase 1
Active, not recruiting NCT03307616 - Nivolumab With and Without Ipilimumab and Radiation Therapy in Treating Patients With Recurrent or Resectable Undifferentiated Pleomorphic Sarcoma or Dedifferentiated Liposarcoma Before Surgery Phase 2
Active, not recruiting NCT04420975 - Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma Phase 1
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Active, not recruiting NCT03899805 - A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas Phase 2
Active, not recruiting NCT03752398 - A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) Phase 1
Recruiting NCT04055220 - Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas N/A
Withdrawn NCT05116800 - Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma Phase 2
Not yet recruiting NCT06422806 - Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas Phase 2
Active, not recruiting NCT03989596 - Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas Phase 2
Not yet recruiting NCT03946943 - Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma Phase 2
Recruiting NCT04008238 - Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients N/A
Recruiting NCT04123535 - Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma N/A
Active, not recruiting NCT04242238 - Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas Phase 1
Completed NCT02584309 - Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Not yet recruiting NCT06277154 - MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma Phase 2
Recruiting NCT03425279 - CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma Phase 1/Phase 2
Active, not recruiting NCT03651375 - Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall Phase 2