Trial results for a Phase 2 study (NCT04326257) investigating personalized nivolumab combinations in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) were posted on ClinicalTrials.gov on 2026-01-08. The study, which included patients who had progressed on prior immunotherapy, reported a 33.3% disease control rate in the selected treatment arm, though objective response was 0% for both treatment strategies.
Background
The study investigated personalized immunotherapy strategies for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who had previously failed anti-PD-1 or PD-L1 mAb therapy. The goal was to select either ipilimumab or relatlimab to add to nivolumab based on gene expression of LAG3 and CTLA4.
Trial design
The Phase 2 trial (NCT04326257) enrolled 20 participants with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who had progressed on prior anti-PD-1 or PD-L1 mAb therapy. The study aimed to evaluate a personalized immunotherapy approach where the addition of either ipilimumab or relatlimab to nivolumab was determined by gene expression of LAG3 and CTLA4. The trial compared outcomes between a 'Selected Treatment' group, where the agent was chosen based on gene expression, and a 'Randomized Treatment' group.
Key results
The trial reported the following key measurements for both the 'Selected Treatment' and 'Randomized Treatment' groups:
- For "Probability of Objective Response (OR)":
- 'Selected Treatment' group: 0 percentage of patients.
- 'Randomized Treatment' group: 0 percentage of patients.
- For "Disease Control Rate (DCR)":
- 'Selected Treatment' group: 33.3 percent probability of participants (95% Confidence Interval).
- 'Randomized Treatment' group: 25.0 percent probability of participants (95% Confidence Interval).
- For "Progression-free Survival (PFS)":
- Median PFS for 'Selected Treatment' group: 52.00 Days (95% Confidence Interval).
- Median PFS for 'Randomized Treatment' group: 53.00 Days (95% Confidence Interval).
- For "Overall Survival (OS)":
- Median OS for 'Selected Treatment' group: 166.00 Days (95% Confidence Interval).
- Median OS for 'Randomized Treatment' group: 164.00 Days (95% Confidence Interval).
- For "Duration of Disease Control":
- Mean duration for 'Selected Treatment' group: 133.50 Days (Standard Deviation: 122.33).
- Mean duration for 'Randomized Treatment' group: 97.67 Days (Standard Deviation: 81.82).
- Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0:
- 3 patients in the Nivolumab+Relatlimab group.
- 1 patient in the Nivolumab+Ipilimumab group.
What this means
The results indicate that while a personalized approach using nivolumab combinations in recurrent/metastatic SCCHN patients who have failed prior immunotherapy did not achieve objective responses, it showed a numerically higher disease control rate and a longer mean duration of disease control compared to the randomized treatment. The median progression-free survival and overall survival were largely comparable between the two groups. These findings suggest limited but potentially differentiated activity in this challenging patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04326257, titled 'Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy,' were posted on 2026-01-08 on clinicaltrials.gov.