Trial results for a Phase 2 study (NCT03107182) investigating nivolumab in combination with chemotherapy and locoregional therapy for patients with head and neck cancer were posted on ClinicalTrials.gov on 2025-05-06. The study reported high 2-year progression-free survival rates ranging from 88% to 100% and 2-year overall survival rates from 87% to 96% across different treatment arms.
Background
The trial, titled 'Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer,' investigated treatment strategies for patients with HPV-Related Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma (HNSCC).
Trial design
The Phase 2 study (NCT03107182) was a completed trial that enrolled 72 participants with HPV-Related Squamous Cell Carcinoma and HNSCC. The trial investigated a combination of carboplatin, nab-paclitaxel, and nivolumab administered for three cycles, followed by Transoral Robotic Surgery (TORS) or radiation/chemoradiation therapy. Patients with specific low-risk and small-volume tonsillar or base of tongue disease who achieved a ≥50% reduction by RECIST following induction chemotherapy were considered for TORS and selective nodal dissection. The study evaluated different treatment strategies, including a Single Modality De-escalation Arm (SDA), an Intermediate De-escalation Arm (IDA), and a Regular Dose Arm (RDA), with interventions including nab-paclitaxel, carboplatin, nivolumab, cisplatin, and hydroxyurea.
Key results
Key results from the trial included measurements for Deep Response Rate (DRR), adverse events, 2-year Progression-free Survival (PFS), and 2-year Overall Survival (OS) across the different arms:
- For the outcome 'Evaluate the Tumor Shrinkage (%) to Measure the Deep Response Rate (DRR)':
- Single Modality De-escalation Arm (SDA): 25 Participants
- Intermediate De-escalation Arm (IDA): 26 Participants
- Regular Dose Arm (RDA): 0 Participants
- For the outcome 'Number of Patients With Adverse Events':
- Single Modality De-escalation Arm (SDA): 27 Participants
- Intermediate De-escalation Arm (IDA): 29 Participants
- Regular Dose Arm (RDA): 10 Participants
- For the outcome '2 Year Progression-free Survival (PFS)':
- Single Modality De-escalation Arm (SDA): 99 percentage of patients (95% Confidence Interval)
- Intermediate De-escalation Arm (IDA): 88 percentage of patients (95% Confidence Interval)
- Regular Dose Arm (RDA): 100 percentage of patients (95% Confidence Interval)
- For the outcome '2 Year Overall Survival (OS)':
- Single Modality De-escalation Arm (SDA): 96 percentage of patients (95% Confidence Interval)
- Intermediate De-escalation Arm (IDA): 91 percentage of patients in each arm (95% Confidence Interval)
- Regular Dose Arm (RDA): 87 percentage of patients in each arm (95% Confidence Interval)
What this means
The high 2-year Progression-free Survival and Overall Survival rates observed across all arms, particularly the Regular Dose Arm (RDA) and Single Modality De-escalation Arm (SDA), suggest that the investigated treatment strategies involving nivolumab in combination with chemotherapy and locoregional therapy may offer significant long-term benefits for patients with HPV-Related Squamous Cell Carcinoma and HNSCC. The varying numbers of participants achieving deep response and experiencing adverse events across the arms indicate potential differences in efficacy and safety profiles that warrant further investigation, especially given the de-escalation approach of some arms.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03107182, titled 'Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer,' were posted on 2025-05-06 on clinicaltrials.gov.