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Synthesis of Phase-shift Nanoemulsions with Narrow Size Distributions for Acoustic Droplet Vaporization and Bubble-enhanced Ultrasound-mediated Ablation
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Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in

Matthew D Galsky1, Karen A Autio2, Christopher R Cabanski3

  • 1Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|February 18, 2025
PubMed
Abstract

Insights

Novel immunotherapy combinations show promise for metastatic castration-resistant prostate cancer. Combination therapy including radiotherapy demonstrated encouraging clinical activity, with baseline immune status predicting benefit.

Area of Science:

  • Oncology
  • Immunotherapy
  • Prostate Cancer Research

Background:

  • Metastatic castration-resistant prostate cancer (mCRPC) has limited treatment options.
  • Current immune checkpoint inhibitors show suboptimal efficacy in mCRPC.
  • Novel combination strategies are needed to improve immunotherapy outcomes.

Purpose of the Study:

  • To evaluate the safety and efficacy of nivolumab-based combination therapies in mCRPC.
  • To explore different combinations including bempegaldesleukin, stereotactic body radiotherapy, CDX-301, poly-ICLC, and INO-5151.
  • To identify biomarkers associated with treatment response.

Main Methods:

  • An open-label, noncomparative platform trial (NCT03835533) enrolled 43 patients with mCRPC.
  • Three cohorts received different nivolumab-based combinations with varying agents and schedules.
  • Primary endpoint was safety; secondary endpoints included response rates, disease control, progression-free survival, and overall survival.

Main Results:

  • Grade 3-4 treatment-related adverse events varied across cohorts (71%, 13%, 14%).
  • Composite response rates were 7% (Cohort A), 33% (Cohort B), and 7% (Cohort C).
  • Six-month disease control correlated with pre-existing immune markers (T cells, TNFα).

Conclusions:

  • The combination of stereotactic body radiotherapy with CDX-301, poly-ICLC, and nivolumab (Cohort B) showed promising clinical activity.
  • Pre-existing immune activation, not treatment-induced, was associated with clinical benefit.
  • Baseline immune fitness is crucial for predicting response to immunotherapy combinations in mCRPC.

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