Actively Recruiting
Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Led by Centre Paul Strauss · Updated on 2025-12-23
46
Participants Needed
5
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study targets an adult population of patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), who have failed after a first line of treatment with pembrolizumab associated or not with chemotherapy and having an indication for a second line of treatment. Patients will be recruited in France in medical oncology departments. The main objective is to evaluate the objective response rate of PCC in patients with HNSCC with locoregional and/or distant 2nd line metastatic disease after failure of pembrolizumab +/- chemotherapy. The secondary objectives of the study are to evaluate other efficacy parameters by monitoring the progression of the disease, the tolerance of the treatment by collecting adverse effects and quality of life. The duration of participation in the research is 12 months.
CONDITIONS
Official Title
Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at inclusion
- Cytological or histological confirmation of invasive squamous cell carcinoma of the head and neck
- Tumor located in oral cavity, oropharynx (with known p16 status), larynx, hypopharynx, or cancers of unknown primary in head and neck
- Metastatic (stage IVc) or recurrent disease not eligible for curative surgery or radiotherapy
- Indication for second-line treatment after pembrolizumab with or without chemotherapy
- Chemotherapy-free interval of at least 3 months
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Documented progression of measurable tumor according to RECIST 1.1
- Acceptable biological test results
- Use of highly effective contraception for males or females of childbearing potential
- Ability and willingness to follow study schedule, treatments, and procedures
- Enrollment in a health insurance plan or beneficiary of such plan
- Signed informed consent obtained before inclusion
You will not qualify if you...
- Any histology other than squamous cell carcinoma
- Tumors located in nasal, paranasal, or nasopharyngeal cavities
- Symptomatic or active brain metastases or leptomeningeal tumors
- Neuropathy grade 2 or higher
- Radiotherapy within 2 weeks before treatment start (except palliative or analgesic radiotherapy)
- Significant heart disease or congestive heart failure NYHA class 2 or above
- Unstable angina in last 3 months or myocardial infarction in last 6 months
- History of other primary malignancies within 3 years except certain treated cancers with no recurrence
- Known allergy to study drugs or excipients
- Uncontrolled medical conditions
- Psychiatric or social issues limiting compliance or consent
- Chemotherapy or radiotherapy within 4 weeks before first dose (except palliative radiotherapy to non-target lesions)
- Major surgery within 4 weeks before treatment (except local palliative surgery)
- Use of phenytoin for prophylaxis
- Live attenuated vaccine within 30 days before treatment and during study up to 6 months after last dose
- Participation in another investigational trial within 4 weeks prior to study treatment
- Pregnant or breastfeeding women
- Women of childbearing potential without negative pregnancy test within 72 hours before treatment
- Hemorrhagic tumors
- History of allergy to red meat, tick bites, or positive IgE tests against cetuximab
- Interstitial lung disease
- History of organ transplant
- Concomitant treatment with Hypericum
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centre hospitalier Régional de Metz-Thionville
Ars-Laquenexy, France, 57085
Actively Recruiting
2
CHU de Besançon
Besançon, France
Actively Recruiting
3
Centre Hospitalier de Colmar
Colmar, France, 68024
Actively Recruiting
4
Centre Paul Strauss
Strasbourg, France, 67033
Actively Recruiting
5
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
Research Team
M
Manon VOEGELIN
CONTACT
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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