Trial results for the Phase 2 study NCT03944915, investigating nivolumab in de-escalation therapy for Human Papillomavirus (HPV) negative Squamous Cell Carcinoma of the Head and Neck (HNSCC), were posted on ClinicalTrials.gov on 2025-05-11. The study found that the Progression Free Survival (PFS) rate was 69% in both the standard and de-escalated chemotherapy arms.
Background
Nivolumab is an immunotherapy drug. This Phase 2 study aimed to evaluate if nivolumab, administered with carboplatin and paclitaxel during induction therapy in advanced stage Human Papillomavirus (HPV) negative patients, could significantly shrink the cancer.
Trial design
The Phase 2 study NCT03944915 enrolled 35 participants with conditions including Human Papilloma Virus negative Squamous Cell Carcinoma of the Head and Neck (HNSCC). The trial investigated the use of nivolumab alongside chemotherapy agents such as carboplatin and paclitaxel. Participants were divided into a Standard Chemotherapy group, with 16 participants, and a De-escalated Chemotherapy group, with 19 participants.
Key results
The trial results provided several key measurements comparing the two treatment arms:
- For Deep Response Rate (DRR):
- Standard Chemotherapy group: 16 Participants
- De-escalated Chemotherapy group: 19 Participants
- For Progression Free Survival Rate (PFS):
- Standard Chemotherapy group: 69 percentage of patients in each arm (95% Confidence Interval)
- De-escalated Chemotherapy group: 69 percentage of patients in each arm (95% Confidence Interval)
- For Overall Survival Rate (OS):
- Standard Chemotherapy group: 79 percentage of patients in each arm (95% Confidence Interval)
- De-escalated Chemotherapy group: 74 percentage of patients in each arm (95% Confidence Interval)
- For Locoregional Control After Completing Chemoradiation:
- Standard Chemotherapy group: 93 percentage of patients in each arm (95% Confidence Interval)
- De-escalated Chemotherapy group: 89 percentage of patients in each arm (95% Confidence Interval)
- For Distant Control After Completing Chemoradiation:
- Standard Chemotherapy group: 90 percentage of patients in each arm (95% Confidence Interval)
- De-escalated Chemotherapy group: 94 percentage of patients in each arm (95% Confidence Interval)
- For Acute and Late Toxicity During Treatment:
- Standard Chemotherapy group: 0 Participants
- De-escalated Chemotherapy group: 0 Participants
What this means
The results indicate that the de-escalated chemotherapy regimen, including nivolumab, achieved a Progression Free Survival rate of 69%, identical to the standard chemotherapy arm. While the Overall Survival rate was slightly lower in the de-escalated group at 74% compared to 79% in the standard group, and locoregional control was 89% versus 93%, the distant control rate was slightly higher at 94% compared to 90%. Notably, both arms reported 0 participants experiencing acute and late toxicity during treatment. These findings suggest that a de-escalated approach might maintain similar progression-free outcomes and low toxicity for HPV-negative HNSCC patients, which could be an important consideration for treatment strategies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03944915, titled 'De-Escalation Therapy for Human Papillomavirus Negative Disease,' were posted on 2025-05-11 on clinicaltrials.gov.