Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With Sarcoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
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⁃ 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 sarcoma for which PD-1 inhibitors are approved (undifferentiated pleomorphic sarcoma, myxofibrosarcoma, angiosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, alveolar soft part sarcoma) who have progressed on at least 1 prior line of therapy. Prior immunotherapy treatment is allowed, including prior treatment with a PD-1 inhibitor.

• 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.

Locations
United States
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Contact Information
Primary
John Rieth, MD
john-rieth@uiowa.edu
3193561616
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2028-07
Participants
Target number of participants: 8
Treatments
Experimental: Combination of Palbociclib with Pembrolizumab
Palbociclib given for 2 weeks following a pre-treatment ultrasound guided biopsy used to establish an immunological baseline of the tumor microenvironment. After the conclusion of palbociclib therapy, a post-treatment 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 could be performed.
Sponsors
Leads: John Rieth

This content was sourced from clinicaltrials.gov