Status:
RECRUITING
Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Centre Paul Strauss
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Head and neck squamous cell carcinoma (HNSCC) is the 7th most common cancer worldwide. First-line treatment was shaken up in 2019 by showing that a combination of platinum, 5-fluorouracil (5-FU) and ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06725368
Start Date
January 24 2025
End Date
January 1 2032
Last Update
December 23 2025
Active Locations (5)
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1
Centre hospitalier Régional de Metz-Thionville
Ars-Laquenexy, France, 57085
2
CHU de Besançon
Besançon, France
3
Centre Hospitalier de Colmar
Colmar, France, 68024
4
Centre Paul Strauss
Strasbourg, France, 67033