P=N/A, N=200, Recruiting, Bristol-Myers Squibb

P2, N=35, Recruiting, University of California, Irvine | Trial primary completion date: Jun 2026 --> Oct 2026

P4, N=50, Recruiting, Replimune Inc. | Phase classification: P --> P4

P2, N=30, Active, not recruiting, Dana-Farber Cancer Institute | N=45 --> 30

P1, N=18, Recruiting, Washington University School of Medicine | Trial completion date: Jul 2031 --> Jan 2034 | Trial primary completion date: Aug 2026 --> Feb 2029

P1/2, N=33, Completed, Imperial College London | Recruiting --> Completed | Trial completion date: Dec 2023 --> Mar 2026 | Trial primary completion date: Sep 2023 --> Mar 2026

P2, N=49, Not yet recruiting, Obstetrics & Gynecology Hospital of Fudan University

Pretreatment intratumoral CD8+ TIL density was associated with an improved response and a longer PFS in STRIDE-treated HCC. Baseline tumor immune contexture may serve as a practical predictive biomarker for STRIDE. These findings are exploratory and hypothesis-generating, and require validation in larger prospective studies.

The SWOG S1801 trial demonstrated better event-free survival with perioperative pembrolizumab compared to adjuvant therapy alone. Lastly, the phase III NADINA trial showed that neoadjuvant ipilimumab plus nivolumab followed by response-adapted adjuvant therapy significantly improves outcomes. Biomarkers such as PD-L1, IFN-γ signature, tumor mutational burden and imaging (PET scan) appear promising to predict response, but none have been sufficiently validated for routine clinical practice.

Relative to chemotherapy, early detriment was observed with nivolumab plus ipilimumab across biomarker subgroups but not with nivolumab plus ipilimumab with chemotherapy. Long-term benefit was maintained with both regimens.

ICIs such as nivolumab and pembrolizumab have transformed recurrent/metastatic HNSCC, and their integration into curative settings is under active investigation.We conducted a PRISMA-compliant systematic review of PubMed, Embase, Cochrane Library, and major oncology conference proceedings (2018-2026) to identify clinical trials evaluating ICIs in the perioperative setting of HNSCC...Combination strategies were more effective: the IMCISION trial reported 35% MPR with nivolumab plus ipilimumab vs. 17% with nivolumab alone...Ongoing trials are refining biomarkers, combinations, and sequencing. Perioperative immunotherapy is reshaping curative-intent management of HNSCC, establishing a new multidisciplinary treatment paradigm.

P3, N=214, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Sep 2026 | Trial primary completion date: Mar 2025 --> Sep 2026