Trial results for a Phase 2 study evaluating nivolumab plus ibrutinib for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) were posted on ClinicalTrials.gov on 2026-05-22. The study, which was terminated, reported that the nivolumab combination arm had a mean progression-free survival of 6.65 weeks and a mean overall survival of 30.7 weeks, both lower than the cetuximab combination arm.
Background
The study investigated ibrutinib in combination with either nivolumab or cetuximab for the treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC).
Trial design
The terminated Phase 2 study (NCT03646461) enrolled 5 participants with head and neck cancer and squamous cell carcinoma of the head and neck. This open-label, randomized trial aimed to test the efficacy of ibrutinib in combination with either nivolumab or cetuximab. Participants received either ibrutinib 560mg po daily plus cetuximab (Arm A) or ibrutinib plus nivolumab (Arm B).
Key results
The trial reported clinical efficacy, progression-free survival (PFS), and overall survival (OS) data:
- Clinical Efficacy of Combined Therapies Using RECIST v1.1:
- In Arm A (Ibrutinib + Cetuximab), 0 participants showed clinical efficacy.
- In Arm B (Ibrutinib + Nivolumab), 0 participants showed clinical efficacy.
- Progression Free Survival:
- For Arm A (Ibrutinib + Cetuximab), the mean PFS was 17.03 weeks (Standard Deviation: 8.58 weeks).
- For Arm B (Ibrutinib + Nivolumab), the mean PFS was 6.65 weeks (Standard Deviation: 1.65 weeks).
- Overall Survival:
- For Arm A (Ibrutinib + Cetuximab), the mean OS was 51.07 weeks (Standard Deviation: 7.53 weeks).
- For Arm B (Ibrutinib + Nivolumab), the mean OS was 30.7 weeks (Standard Deviation: 16.3 weeks).
What this means
The results from this terminated Phase 2 study suggest that the combination of ibrutinib with nivolumab may not be as effective as ibrutinib with cetuximab in recurrent/metastatic HNSCC. The mean progression-free survival for the nivolumab arm was 6.65 weeks compared to 17.03 weeks for the cetuximab arm. Similarly, mean overall survival was 30.7 weeks for the nivolumab arm versus 51.07 weeks for the cetuximab arm. The reported 0 participants showing clinical efficacy in both arms indicates a lack of objective responses as per RECIST v1.1. The termination of the trial, coupled with these outcomes, suggests that the ibrutinib plus nivolumab combination did not demonstrate a favorable efficacy profile in this small patient cohort.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03646461, titled "Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC", were posted on 2026-05-22 on clinicaltrials.gov.