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

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 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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Other histology
2. Nasal, paranasal and nasopharyngeal cavities
3. Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
4. Grade ≥2 neuropathy
5. Patients may have previously received radiotherapy. A minimum period of 2 weeks is necessary between palliative or analgesic radiotherapy and the start of treatment
6. 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.
7. 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.
8. Known hypersensitivity to the active substance or excipient of the treatments under study
9. Any uncontrolled intercurrent pathology
10. Any psychiatric illness/social situation that may limit compliance with study procedures or prevent the patient from giving written informed consent
11. Any chemotherapy or radiotherapy performed within 4 weeks of the first dose of study drug, except palliative radiotherapy to a non-target lesion
12. Major surgery within 4 weeks before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated
13. Phenytoin prescribed for prophylaxis
14. 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
15. Participation in another clinical trial of an investigational treatment during the 4 weeks preceding the first administration of the study treatment
16. Pregnant or breastfeeding women
17. Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment.
18. Patients presenting hemorrhagic tumor
19. History of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose)
20. Patient presenting interstitial lung disease
21. History of organ transplant
22. Concomitant treatment with Hypericum

Conditions2

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