OncoMatch/Clinical Trials/NCT07065630
Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer
Is NCT07065630 recruiting? Yes, currently enrolling (May 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
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
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