Actively Recruiting
Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Led by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello · Updated on 2025-08-21
65
Participants Needed
11
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Squamous cell carcinoma of the head and neck (SCCHN) arises from epithelial cells and occurs in the oral cavity, pharynx and larynx. SCCHN is the seventh most common cancer worldwide with an annual incidence of approximately 90.000 cases per year in Europe. Recurrent / metastatic SCCHN remains a grievous diagnosis and optimal treatment options after progression to first-line ICI treatment are not determined yet. Previous reports showed that cetuximab plus paclitaxel after progression to ICI therapy may have an enhanced activity as second line after ICI therapy ERBIOTAX is multi-center, open-label, randomized, non-comparative two-arm, phase 2 trial Investigator Initiated Study. The primary study aims is to evaluate the efficacy of weekly cetuximab combined with paclitaxel (Arm A) or cetuximab monotherapy (Arm B) after progression to pembrolizumab plus platinum / 5-FU. The efficacy of treatment will be assessed through objective response rate (ORR). Patients will be randomized in a 2:1 ratio to ERBITAX (cetuximab + paclitaxel) and cetuximab, respectively, assigning 2 patients to Arm A and 1 patient to Arm B out of 3 patients. No stratification for the randomization process is planned as this is a non-comparative study. A total of 65 evaluable patients will be included in the trial; 41 in Arm A and 24 in Arm B. The main hypothesis is that treatment with the cetuximab +/- paclitaxel regimen maybe more effective after immune checkpoint inhibitors (ICI) failure in patients with recurrent/metastatic head and neck squamous cell carcinoma.
CONDITIONS
Official Title
Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written and voluntary informed consent.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Age over 18 years.
- Histologically confirmed diagnosis of head and neck squamous cell carcinoma.
- Primary tumor located in oropharynx, oral cavity, hypopharynx, or larynx.
- Known HPV status for oropharyngeal tumors tested by p16 and/or HPV DNA.
- Confirmed disease progression per RECIST 1.1 after pembrolizumab plus platinum/5-FU first-line therapy.
- Measurable disease by CT or MRI scan.
- Tumor biopsy obtained prior to study treatment; newly obtained biopsy preferred.
- ECOG performance status of 0 or 1.
- Adequate organ function as defined by blood counts and biochemistry within specified limits.
- Post-menopausal status or negative pregnancy test for women of childbearing potential.
- Use of effective contraception or surgical sterilization during study and specified period after.
- Male participants agree to use effective contraception during study and specified period after.
You will not qualify if you...
- Tumors arising from nasopharynx, nasal cavity, paranasal sinuses, salivary glands, skin, or unknown primary site.
- Not treated with or not progressed on pembrolizumab plus platinum/5-FU first-line therapy.
- Previous treatment with paclitaxel or cetuximab in recurrent/metastatic setting.
- Active central nervous system metastases or carcinomatous meningitis.
- Life expectancy less than 3 months or rapidly progressing disease.
- History of another primary malignancy unless treated and disease-free for over 3 years or specific low-risk cancers.
- Major surgery within 28 days before treatment.
- Recent focal palliative radiotherapy not completed 2 weeks prior to treatment.
- Allergic or hypersensitivity reactions to study drugs or excipients.
- History of organ transplant requiring immunosuppression or severe immune therapy toxicity.
- Concurrent cancer treatments excluding certain hormones.
- Recent immunosuppressive medication use with specific exceptions.
- Unresolved immune-related adverse events grade above 2.
- History of primary immune deficiency or certain infections.
- Recent stroke or transient ischemic attack.
- Certain cardiac conditions including unstable angina, heart failure, arrhythmia, or low ejection fraction.
- Pre-existing neuropathy grade 2 or higher.
- History of severe lung disease or uncontrolled lung conditions.
- Active hepatitis B or C infection unless controlled.
- Pregnant or breastfeeding women.
- Uncontrolled infections or psychiatric/social conditions affecting compliance.
- Any condition interfering with study treatment or safety evaluation.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Instituto Catalán de Oncología - Hospital Duran i Reynals
Barcelona, Barcelona, Spain, 08908
Actively Recruiting
2
Hospital Universitario Marqués de Valdecilla (Santander)
Santander, Cantabria, Spain, 39008
Actively Recruiting
3
Centro Oncológico de Galicia (La Coruña)
A Coruña, La Coruña, Spain, 15009
Actively Recruiting
4
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
5
Hospital Universitario 12 de Octubre (Madrid)
Madrid, Madrid, Spain, 28041
Actively Recruiting
6
Hospital Infanta Leonor (Madrid)
Vallecas, Madrid, Spain, 28031
Actively Recruiting
7
Complejo Hospitalario de Navarra (Pamplona)
Pamplona, Navarre, Spain, 31008
Actively Recruiting
8
Complejo Hospitalario de Salamanca (Salamanca)
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
9
Hospital Universitario de Canarias (La laguna)
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
Actively Recruiting
10
Hospital Universitario Virgen del Rocío (Sevilla)
Seville, Sevilla, Spain, 41013
Actively Recruiting
11
Hospital Universitario Virgen de Valme (Sevilla)
Seville, Sevilla, Spain, 41014
Actively Recruiting
Research Team
F
Federico Nepote, M.D., PhD.
CONTACT
M
Marisa Duran Senior Clinical research proyect manager (TTCC)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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