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A Pilot Study of Pembrolizumab Combined With Stereotactic Ablative Radiotherapy for Patients With Advanced or
Jeremy P Harris1, Jino Park1, Eric Ku1
1Department of Radiation Oncology, University of California Irvine, Orange, CA, USA.
Cancer Control : Journal of the Moffitt Cancer Center
|March 7, 2024
Summary
This pilot study explores combining stereotactic body radiation therapy (SBRT) with pembrolizumab to improve responses in metastatic soft tissue sarcoma patients. The goal is to enhance immunotherapy effectiveness beyond the treated tumor site.
Area of Science:
- Oncology
- Immunotherapy
- Radiation Oncology
Background:
- Metastatic soft tissue sarcoma (STS) has limited response rates to single-agent immunotherapy like pembrolizumab (18% ORR, 18-week PFS).
- Stereotactic body radiation therapy (SBRT) may enhance immunotherapy by releasing tumor antigens and boosting CD8 T cell responses.
- Combining SBRT with immune checkpoint inhibitors (ICIs) is a strategy to improve clinical outcomes in STS.
Purpose of the Study:
- To test the feasibility of combining SBRT with pembrolizumab in patients with metastatic STS.
- To evaluate the potential of combination therapy to improve overall response rates, including abscopal effects.
Main Methods:
- A phase 0, pilot prospective single-center study with two arms.
- Arm A: Patients receive pembrolizumab (400 mg IV) every 42 days, with SBRT delivered in 1-5 fractions starting between C1D15-28.
- Arm B: Patients already on an ICI receive SBRT in addition to their current therapy.
Main Results:
- This study outlines the feasibility testing of adding SBRT to pembrolizumab treatment.
- Results focus on the procedural and safety aspects of the combination therapy.
Conclusions:
- The combination of SBRT and pembrolizumab aims to improve overall response in metastatic STS.
- The ultimate goal is to achieve enhanced responses in both irradiated and non-irradiated tumors.
- Clinical trial registration: NCT05488366.
