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New treatment option for Head and Neck Cancer
Official title Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT06725368
What this study is testing
What is PCC?
PCC is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Clinically significant heart disease or congestive heart failure NYHA (New York Heart Association) class 2 or greater. Patients must not have had...
See the full eligibility criteria
- 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ars-Laquenexy, France
- Besançon, France
- Colmar, France
- Strasbourg, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ars-Laquenexy, France; Besançon, France; Colmar, France; Strasbourg, France; Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.