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Carboplatin + Paclitaxel + Cetuximab (PCC) after failure of first line Immune checkpoint inhibitor with or without chemotherapy in recurrent/metastatic squamous cell carcinoma of the head and neck: CARPACCIO (CARboplatin PAClitaxel Cetuximab IO immuno-oncology)
EU CTIS ID: 2024-512297-96-01
What this study is testing
Objective response rate of PCC in patients with second line recurrent or metastatic head and neck squamous cell carcinoma after failure of an Immune checkpoint inhibitor with or without chemotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age greater than or equal to 18 years at inclusion
- Documented progression of a measurable tumor target according to RECIST 1.1
- Correct biology
- 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
You likely can't join if
- Other histology
- Major surgery within 4 weeks (= 28 days) before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated
- Nasal, paranasal and nasopharyngeal cavities
- Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
- Grade equal or greater than to 2 for neuropathy
- Patients may have previously received radiation therapy. A minimum period of 2 weeks is necessary between palliative or analgesic radiotherapy and the start of treatment
See the full eligibility criteria
- Age greater than or equal to 18 years at inclusion
- Documented progression of a measurable tumor target according to RECIST 1.1
- Correct biology
- 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 second line after Immune checkpoint inhibitor with or without chemotherapy
- Chemotherapy-free interval equal or greater than 3 months
- ECOG Performance Index (Performance Index) of 0, 1 or 2
- Patient with a life expectancy of at least 12 weeks
- Other histology
- Major surgery within 4 weeks (= 28 days) before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated
- Nasal, paranasal and nasopharyngeal cavities
- Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
- Grade equal or greater than to 2 for neuropathy
- Patients may have previously received radiation therapy. 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
- Known hypersensitivity to the active substance or excipient of the treatments under study
- Any chemotherapy or radiation therapy performed within 4 weeks (= 28 days) of the first dose of study drug, except palliative radiation therapy to a non-target lesion
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.