Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Recruiting now · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT06725368

Run by

Centre Paul Strauss

People needed

46

Starts

2025-01-24

Expected to finish

2032-01-01

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years at inclusion
• Cytological or histological confirmation of the diagnosis of invasive squamous cell carcinoma of the head and neck
• One of the following locations: oral cavity, oropharynx (known p16 status), larynx or hypopharynx
• Cancers of unknown primary (CUP) of the head and neck are accepted
• Metastatic (stage IVc) or recurrent disease in patients ineligible for curative surgical treatment or radiotherapy
• Indication of a 2nd line after pembrolizumab +/- chemotherapy
• Chemotherapy-free interval ≥ 3 months
• ECOG Performance Index (Performance Index) of 0, 1 or 2
• Patient with a life expectancy of at least 12 weeks
• Documented progression of a measurable tumor target according to RECIST 1.1
• Correct biology
• Patient (male or female of childbearing potential) using a highly effective contraceptive method
• Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study
• Patient enrolled in a health insurance plan or beneficiary of such a plan
• Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information)

You may not qualify if…

• Other histology
• Nasal, paranasal and nasopharyngeal cavities
• Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
• Grade ≥2 neuropathy
• Patients may have previously received radiotherapy. A minimum period of 2 weeks is necessary between palliative or analgesic radiotherapy and the start of treatment
• Clinically significant heart disease or congestive heart failure NYHA (New York Heart Association) class 2 or greater. Patients must not have had unstable angina (symptoms of angina at rest) or new angina in the last 3 months or myocardial infarction in the last 6 months.
• History of other primary malignancies, except curatively treated malignancies with no evidence of recurrence, within 3 years before the first dose of treatment and a low potential risk of recurrence or non-recurrent skin cancer. melanoma or lentigo maligna properly treated without evidence of disease or carcinoma in situ adequately treated without evidence of disease. A history of T1 grade bladder cancer or T1 grade kidney cancer is accepted. Cervical carcinoma in situ or breast cancer in situ are accepted. Patients with papillary thyroid carcinoma, basal cell skin carcinoma are accepted. A history of prostate cancer is allowed if it is less than or equal to stage T2N0M0 and a Gleason score of 6.
• Known hypersensitivity to the active substance or excipient of the treatments under study
• Any uncontrolled intercurrent pathology
• Any psychiatric illness/social situation that may limit compliance with study procedures or prevent the patient from giving written informed consent
• Any chemotherapy or radiotherapy performed within 4 weeks of the first dose of study drug, except palliative radiotherapy to a non-target lesion
• Major surgery within 4 weeks before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated
• Phenytoin prescribed for prophylaxis
• Administration of a live attenuated vaccine within 30 days before the first administration of study treatment, as well as during the duration of study treatment and up to 6 months after the last dose of treatment
• Participation in another clinical trial of an investigational treatment during the 4 weeks preceding the first administration of the study treatment
• Pregnant or breastfeeding women
• Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment.
• Patients presenting hemorrhagic tumor
• History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose)
• Patient presenting interstitial lung disease
• History of organ transplant
• Concomitant treatment with Hypericum

Where it is running

• Centre hospitalier Régional de Metz-Thionville — Ars-Laquenexy, France (enrolling)
• CHU de Besançon — Besançon, France (enrolling)
• Centre Hospitalier de Colmar — Colmar, France (enrolling)
• Centre Paul Strauss — Strasbourg, France (enrolling)
• Institut de cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (enrolling)

Full record on ClinicalTrials.gov

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