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Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.

NCT06869473 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-03-14

No results posted yet for this study

Summary

This phase II interventional clinical trial aims to evaluate whether combining cetuximab and avelumab, after three cycles of platinum and taxane-based chemotherapy, can improve treatment outcomes for patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) between 1 and 19. Specifically, the study seeks to determine if this approach can increase the 6-month progression-free survival (PFS) rate from 40% to 55%.

The trial will include adult patients with confirmed R/M HNSCC, who have not previously received systemic therapy for their advanced disease. By testing this sequential treatment strategy, researchers hope to improve outcomes for this specific patient population, which has shown poorer responses to existing immunotherapy options compared to those with higher PD-L1 expression levels.

Participants will first undergo an induction phase, consisting of three cycles of chemotherapy with paclitaxel, platinum (cisplatin or carboplatin), and cetuximab. After this initial treatment, they will move to a maintenance phase, where they will receive avelumab and cetuximab every two weeks until disease progression or the occurrence of unacceptable side effects.

The study aims to answer several key questions:

Can this treatment approach improve progression-free survival at 6 months? What impact does it have on overall survival, response rates, and the duration of response? Is this combination therapy safe and well-tolerated? In addition to the treatment itself, participants will be asked to provide blood and tumor tissue samples for translational research, helping scientists better understand how biomarkers influence treatment response. Regular follow-up assessments will also be conducted to monitor disease progression and overall health.

By testing this innovative treatment sequence, researchers hope to bridge the gap between different PD-L1 subgroups, potentially offering a more effective and personalized approach for patients with R/M HNSCC.

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Recurrent Head and Neck Cancer
  • Metastatic Head and Neck Cancer

Interventions

DRUG

Cetuximab/avelumab

Study Maintenance therapy: AVEC (each cycle every 2 weeks) Cetuximab will be administered at 500 mg/m2 dose (as a 2-hour intravenous infusion) every 2 weeks until disease progression or unacceptable side effects. Cetuximab will be administered by IV infusion over 120 minutes. The initial dose should be given slowly and speed of infusion must not exceed 5 mg/min. Avelumab will be administered at 800 mg flat dose (as a 1-hour intravenous fusion) every 2 weeks until disease progression or unacceptable side effects.

Sponsors & Collaborators

  • Merck Serono S.P.A., Italy

    collaborator INDUSTRY

  • Clinical Research Technology S.r.l.

    collaborator INDUSTRY

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2027-08-20
Completion
2028-02-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869473 on ClinicalTrials.gov