Clinical trial · Interventional
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab
- description
- Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
- interventionNames
- Drug: Pembrolizumab
- Procedure: Surgery
- Radiation: Radiation Therapy
- Drug: Cisplatin
Primary outcomes (3)
- measure
- Number of Participants With Treatment Related Adverse Effects
- timeFrame
- All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.
- description
- Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients eligible for resection with one or more of the following 1. Any T stage with ≥ N2 disease; 2. T4 disease, any N stage; 3. T3 Oral Cavity, any N stage; or 4. Clinical evidence of extra-capsular extension on scans. * Must be willing to undergo definitive resection with neck dissection. * Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale. * Adequate labs * Appropriate staging imaging. Exclusion Criteria: * Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment. * Nasopharyngeal or sinonasal carcinoma * Confirmed metastatic disease * Human Papillomavirus (HPV)+ disease of the oropharynx * Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
References
Publications (1)
- DERIVEDBandaru R, Fu H, Zheng H, Liang J, Wang L, Gulati S, Hinrichs BH, Teng M, Zhang B, Kocherginsky M, Lin DC, Hildeman DA, Worden FP, Old M, Dunlap NE, Kaczmar JM, Gillison ML, El-Gamal D, Wise Draper T, Liu Y. Genome-wide variation in cell-free DNA end-motif entropy predicts immunotherapy response in head and neck cancer. J Clin Invest. 2026 May 19;136(13):e196284. doi: 10.1172/JCI196284. eCollection 2026 Jul 1. PMID 42154530