Actively Recruiting
A Single-arm Phase II Study of Cetuximab Plus Platinum and Taxane-based Chemotherapy Followed by Avelumab and Cetuximab as First-line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients With PD-L1 Combined Positive Score 1 to 19
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2025-03-14
67
Participants Needed
8
Research Sites
26 weeks
Total Duration
On this page
Sponsors
G
Gruppo Oncologico del Nord-Ovest
Lead Sponsor
M
Merck Serono S.P.A., Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment sequence for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have a PD-L1 combined positive score (CPS) between 1 and 19. This phase II trial explores whether starting with chemotherapy combined with cetuximab, followed by maintenance therapy with avelumab and cetuximab, can improve six-month progression-free survival compared to prior therapies. The study addresses the unmet need for patients who respond less well to current immunotherapies. Participants will first receive an induction phase of three cycles of chemotherapy with paclitaxel, a platinum drug (cisplatin or carboplatin), and cetuximab over nine weeks. Those who respond or have stable disease will then enter a maintenance phase, receiving intravenous avelumab and cetuximab every two weeks until the disease worsens or side effects become unacceptable. The study includes translational research with blood and tumor tissue samples to better understand treatment effects on tumor biology and immune response. During the trial, participants will undergo regular assessments to monitor disease progression, overall survival, response rates, and treatment safety for up to 12 months. Blood and tumor samples will be collected at specific times to study biomarkers and immune cell changes. The primary measure is progression-free survival at six months, and safety will be closely followed. The total duration depends on individual response and tolerance of treatment.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent and 18 years or older
- Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma
- Recurrent or metastatic HNSCC not suitable for curative loco-regional therapy
- PD-L1 combined positive score between 1 and 19
- Measurable disease according to RECIST Criteria 1.1
- No prior systemic therapy for recurrent or metastatic HNSCC
- Previous systemic therapy for locally advanced disease allowed if completed over 6 months ago
- ECOG Performance Status 0 or 1
- Adequate bone marrow, liver, and renal function based on specified laboratory values
- Available archival or fresh tumor tissue samples before starting treatment
- Willing to provide peripheral blood samples as required
- Palliative radiotherapy or surgery allowed within 4 weeks before study entry
- Patients with certain neuropathy or ototoxicity grades may receive carboplatin instead of cisplatin
You will not qualify if you...
- Nasopharyngeal, salivary gland, nasal sinus, and non-melanoma skin cancers
- Life expectancy less than 3 months
- Prior chemotherapy, biological therapy, or immunotherapy for recurrent/metastatic HNSCC
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 30 days that cannot be stopped
- Known allergy to study drugs or components
- Active autoimmune disease requiring recent systemic treatment
- Autoimmune disease likely to worsen with immunotherapy except some stable conditions
- Additional malignancies within 5 years except certain treated skin or in situ cancers
- Conditions or therapies that could interfere with trial participation or results
- Significant neurological, psychiatric, or substance abuse disorders
- Clinically significant cardiovascular disease within 6 months
- Prior organ or stem-cell transplantation
- Active uncontrolled infections requiring systemic therapy
- Known HIV infection or acquired immunodeficiency syndrome
- Hepatitis B or C infection at screening
- Live vaccination within 30 days before treatment start
- Pregnancy or breastfeeding; women of childbearing potential must use effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants receive induction treatment with Cetuximab combined with platinum- and taxane-based chemotherapy to reduce tumor burden and modulate the immune microenvironment.
3 cycles every 3 weeks with weekly Cetuximab infusions during induction
Duration - Until disease progression or unacceptable toxicity
Participants who respond or have stable disease enter maintenance therapy with Avelumab and Cetuximab until disease progression, unacceptable toxicity, or withdrawal.
Infusions every 2 weeks
Trial Site Locations
Total: 8 locations
1
Ospedale Oncologico "A. Businco" ARNAS BROTSU
Cagliari, CAGLIARI, Italy, 09121
Not Yet Recruiting
2
Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-S. Marco
Catania, CATANIA, Italy, 95123
Not Yet Recruiting
3
Azienda Ospedaliero-Universitaria Careggi
Florence, FIRENZE, Italy, 50134
Actively Recruiting
4
Fondazione IRCCS Istituto Nazionale dei Tumori (INT) di Milano
Milan, Milano, Italy, 20133
Actively Recruiting
5
Irccs Humanitas Research Hospital
Rozzano, Milano, Italy, 20089
Not Yet Recruiting
6
Irccs Fondazione G. Pascale
Naples, Napoli, Italy, 80131
Actively Recruiting
7
AOU Luigi Vanvitelli
Naples, NAPOLI, Italy, 80138
Not Yet Recruiting
8
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, roma, Italy, 00189
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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