OncoMatch/Clinical Trials/NCT06239220
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
Official title: A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)
Is NCT06239220 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including PD-L1 t-haNK and NAI for head and neck cancer.
Treatment: PD-L1 t-haNK · Cetuximab · NAI — The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer. The names of the therapies involved in this study are: * PD-L1 t-haNK cell therapy (a NK cell therapy infusion) * NAI (a type of recombinant human superagonist) * Cetuximab (a type of antibody)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV wild-type
HPV negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy for recurrent/metastatic HNSCC — recurrent/metastatic HNSCC
Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R/M HNSCC
Must have received: anti-PD-1/PD-L1 therapy — recurrent/metastatic HNSCC
one of these lines should have included anti-PD-1/L1 therapy
Cannot have received: systemic therapy for recurrent/metastatic HNSCC
Have been previously treated with 3 or more lines of systemic therapy for R/M HNSCC
Lab requirements
Blood counts
anc ≥1,000/mcl; hemoglobin ≥9 g/dl; platelets ≥100,000/mcl
Kidney function
serum creatinine ≤1.5x uln or creatinine clearance ≥60 ml/min/1.73 m2 for participants with creatinine levels above 1.5x uln
Liver function
total bilirubin ≤ uln; ast(sgot)/alt(sgpt) ≤2.5x institutional uln (or ≤1.5x institutional uln if concomitant with alkaline phosphatase >2.5x institutional uln) or ≤5x uln for those with liver metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06239220 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for recurrent/metastatic HNSCC disqualifies patients from enrollment.
Does this trial require HPV?
Yes, HPV wild-type is a required biomarker for enrollment.
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