Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06113809
Other study ID # 202305133
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 1, 2024
Est. completion date July 2028

Study information

Verified date May 2024
Source University of Iowa
Contact Mohammed Milhem, MBBS
Phone (319) 356-2324
Email mohammed-milhem@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date July 2028
Est. primary completion date July 2028
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria A potential subject must meet all the following inclusion criteria to be eligible to participate in the study: - Male or female patients aged > or = 12 years old - ECOG Performance Status of < or = 2 - Any patient with the diagnosis of locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) who have progressed on at least 1 prior line of therapy. Prior immunotherapy treatment is allowed. - Patients with no known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing treatment for dexamethasone (as ascertained by clinical examination and brain imaging) during the screening period. Stable dose of anticonvulsants is allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded. - Ability to understand and the willingness to sign a written informed consent or assent in case of patients < 18 years old. Exclusion Criteria A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study: - Lab values in the below ranges: - Neutrophil count < 1000/mm3 - Platelet count < 100,000/mm3L - Hemoglobin < 9 g/dL (transfusion to meet eligibility allowed) - AST/SGOT and ALT/SGPT > 3.0x upper limit of normal (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 - History or drug induced pneumonitis (both pembrolizumab and palbociclib can cause pneumonitis) - Subjects requiring hemodialysis - Patients with severe hepatic impairment (Childs-Pugh Class C). - Other concurrent severe and/or uncontrolled medical conditions in the opinion of the investigator which will preclude participation - Pregnancy (positive pregnancy test) or lactation - Concomitant use of any other anti-cancer therapy or radiation therapy of the target lesion. Palliative radiation therapy is permitted to non-target lesions. - Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Palbociclib
Palbociclib is a CDK4/6 inhibitor. Palbociclib, 125 mg, (pediatric dose 75mg/m2 up to 125mg) daily for 21 days out of every 28 days, PO (orally) starting 14 days prior to Pembrolizumab
Pembrolizumab
Pembrolizumab is a PD-1 blocking antibody. Given 14 days following Palbociclib: Pembrolizumab, 200 mg, once every three weeks, intravenously (IV)

Locations

Country Name City State
United States University of Iowa Hospitals & Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Mohammed Milhem

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Progression free survival To assess progression free survival as calculated by the time from start of treatment until the time of progression of disease or death due to any cause Up to two years following completion of treatment
Primary Dose limiting toxicities (DLTs) and adverse events (AEs) per CTCAE v5 Confirm the safety of the combination of Palbociclib and Pembrolizumab in UPS as defined by the incidence of DLTs The dose limiting toxicity period is 4 weeks after starting the first dose of pembrolizumab
Secondary Response rate per RECIST 1.1 criteria To assess the response (per RECIST 1.1 criteria) of patients with advanced UPS with the combination of CDK4/6 inhibitor and anti-PD-1 immunotherapy 8 weeks following treatment intiation
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