Trial reportInternational journal of radiation oncology, biology, physics2026
Stereotactic Body Radiation Therapy With Pembrolizumab in Programmed Cell Death Protein 1 Inhibitor-Refractory Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Trial.
Trial report in International journal of radiation oncology, biology, physics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03085719 (Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in Squamous Cell Carcinoma of the Head and Neck), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Who cites it
1 citing paper in PubMed.
- Dissociated Response to Immune Checkpoint Inhibition in Head and Neck Squamous Cell Carcinoma Is Common and Exhibits Distinct Clinical Outcomes.Cancer research communications · 2026Article
Corrections and comments
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Authors and funding
24 authors.
Funding
Abstract
purposeTo evaluate the safety, feasibility, and clinical efficacy of stereotactic body radiation therapy (SBRT) combined with pembrolizumab in patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma who progressed on prior PD-1 inhibitor therapy. METHODS AND MATERIALS: This prospective, nonrandomized phase 2 trial enrolled patients with PD-1 inhibitor-refractory R/M head and neck squamous cell carcinoma. In cohort A, a single lesion was treated with SBRT, whereas other sites were left unirradiated. In cohort B, all known oligometastatic lesions were treated with SBRT. Pembrolizumab was administered every 3 weeks in both cohorts. The primary endpoint was 3-month progression-free survival (PFS). Correlative immune analyses were performed on peripheral blood mononuclear cells using mass cytometry and TCRβ sequencing.
resultsEighteen patients were treated (6 in cohort A and 12 in cohort B). The median PFS was 1.8 months in cohort A and 5.7 months in cohort B. The 3-month PFS rate was 17% (1/6) in cohort A and 67% (8/12) in cohort B, with an overall response rate of 25% (3/12) in cohort B and no objective responses in cohort A. Median overall survival was 7.6 months (95% CI, 0.7-32.9) in cohort A and 10.1 months (95% CI, 5.8-49.7) in cohort B. In cohort B, there were 2 (2/12, 17%) grade 4 toxicities observed in the setting of re-irradiation. Correlative studies showed that patients with PFS >3 months had higher baseline frequencies of CD8+ central-memory T cells and elevated CXCR5 expression on memory B cells.
conclusionsIn anti-PD-1-refractory R/M head and neck squamous cell carcinoma, SBRT with pembrolizumab was safe and feasible, suggesting activity when all progressing lesions were treated. Immune profiling describes pre-existing memory T- and B-cell phenotypes that appear to correlate with treatment benefit. These findings support further study and clinical use of comprehensive SBRT plus PD-1 blockade in this hard-to-treat population.
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