Trial results for the Phase 2 study NCT04030455, investigating pembrolizumab in combination with cisplatin and docetaxel for patients with Stage II-III Laryngeal Cancer, were posted on ClinicalTrials.gov on 2026-02-17. The study reported participant counts for clinical benefit rate (CBR) and pathological complete response (pCR), as well as adverse events.
Background
The study NCT04030455, titled "Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer," aimed to evaluate a combination therapy for laryngeal squamous cell carcinoma. The trial investigated the use of chemotherapy drugs cisplatin and docetaxel alongside the immunotherapy agent pembrolizumab for patients with Stage II or Stage III laryngeal cancer.
Trial design
The study NCT04030455 was a Phase 2 trial that enrolled 28 participants. It investigated the combination of cisplatin, docetaxel, and pembrolizumab in patients diagnosed with Stage II or Stage III laryngeal cancer, specifically laryngeal squamous cell carcinoma. The trial evaluated outcomes in the experimental group receiving this combination therapy.
Key results
The trial results provided participant counts for the outcome "CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD)" in the Experimental (Cis/Doce/Pembro) group:
- 12 Participants
- 1 Participant
- 10 Participants
- 1 Participant
- 1 Participant
- 4 Participants
- 19 Participants
- 20 Participants
- 4 Participants
For the outcome "Safety and Tolerability of PCD in Patients With Larynx SCC -- Number of Adverse Events" in the Experimental (Cis/Doce/Pembro) group, the following numbers of adverse events were reported:
- 0 adverse events
- 3 adverse events
- 0 adverse events
What this means
The posted results for this Phase 2 trial provide initial data on the use of pembrolizumab combined with cisplatin and docetaxel for patients with Stage II-III laryngeal cancer. The reported participant counts for clinical benefit rate, pathological complete response, and adverse events offer preliminary insights into the activity and safety profile of this triple combination in the studied population. Further interpretation would require additional context, such as full study protocols and statistical analyses, which were not provided in the posted results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04030455, titled "Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer," were posted on 2026-02-17 on clinicaltrials.gov.