OncoMatch/Clinical Trials/NCT07065630
Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer
Is NCT07065630 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Volrustomig and Carboplatin for head and neck cancer.
Treatment: Volrustomig · Carboplatin · Paclitaxel — The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma .
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV negative by immunohistochemistry (p16 negative)
If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry (defined as negative immunohistochemical staining of p16)
Required: HPV negative
Non-oropharyngeal primary sites...if they are performed, must be negative for HPV
Required: HPV negative
Nasopharyngeal primary must have both EBV and HPV ruled out by immunohistochemistry to be eligible
Required: EBV negative
Nasopharyngeal primary must have both EBV and HPV ruled out by immunohistochemistry to be eligible
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
No previous radiation...for a head and neck cancer
Cannot have received: chemotherapy
No previous...chemotherapy...for a head and neck cancer
Cannot have received: immunotherapy
No previous...immunotherapy for a head and neck cancer
Cannot have received: surgery
Exception: incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors with residual measurable tumor allowed
No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.)
Lab requirements
Blood counts
Leukocytes ≥3,000/mcL; Absolute neutrophil count ≥ 1.5 × 10^9/L (1,500 per mm3); Platelet count ≥ 100 × 10^9/L (100,000 per mm3); Hemoglobin ≥ 9.0 g/dL (5.59 mmol/L)
Kidney function
Creatinine within normal institutional limits OR eGFR (using CKD-EPI equation)≥45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Liver function
Total bilirubin ≤ 1.5 × ULN in the absence Gilbert's syndrome ≤ 3×ULN if the subject has Gilbert's syndrome; Alanine transaminase and aspartate transaminase ≤ 3 × ULN
Cardiac function
LVEF as assessed by echocardiography or multiple-gated acquisition scan ≥ 50%; Troponin I or T ≤ ULN (institutional guidelines and/or not clinically significant per investigator judgement); QTcF ≤ 480 msec
Patients must have adequate organ and marrow function as defined below * Leukocytes ≥3,000/mcL * Absolute neutrophil count ≥ 1.5 × 109/L (1,500 per mm3) * Platelet count ≥ 100 × 109/L (100,000 per mm3) * Hemoglobin ≥ 9.0 g/dL (5.59 mmol/L) * Total bilirubin ≤ 1.5 × ULN in the absence Gilbert's syndrome ≤ 3×ULN if the subject has Gilbert's syndrome * Alanine transaminase and aspartate transaminase ≤ 3 × ULN * LVEF as assessed by echocardiography or multiple-gated acquisition scan ≥ 50% * Troponin I or T≤ ULN (institutional guidelines and/or not clinically significant per investigator judgement) * QTcF ≤ 480 msec * Creatinine within normal institutional limits OR eGFR (using CKD-EPI equation)≥45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Chicago · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07065630 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require HPV?
Yes, HPV negative by immunohistochemistry (p16 negative) is a required biomarker for enrollment.
Does this trial require HPV?
Yes, HPV negative is a required biomarker for enrollment.
Does this trial require HPV?
Yes, HPV negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages