Head and Neck CancerPhase 2CARPACCIONCT06725368
Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing PCC in people with Head and Neck Cancer, run by Centre Paul Strauss at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- PCC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesFrance
- Study dates
- 24 Jan 2025to Jan 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
- 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.
Show all 22Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre hospitalier Régional de Metz-Thionville
Ars-Laquenexy, 57085
Raffaele LONGO, MD, +33387553554, r.longo@chr-metz-thionville.fr
Raffaele LONGO, MD
- Recruiting
CHU de Besançon
Besançon
Tristan Maurina, MD, +33370632403, t1maurina@chu-besancon.fr
Tristan MAURINA, MD
- Recruiting
Centre Hospitalier de Colmar
Colmar, 68024
Jean-Marc LIMACHER, MD, +33389124471, Jean-marc.limacher@ch-colmar.fr
Jean-Marc LIMACHER, MD
- Recruiting
Centre Paul Strauss
Strasbourg, 67033
Anne ANTHONY, PhD, an.anthony@icans.eu
Carole PFLUMIO, MD
- Recruiting
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Lionnel GEOFFROIS, MD, +33 3 83 59 84 61, l.geoffrois@nancy.unicancer.fr
Lionnel GEOFFROIS, MD
About this study
Official title: Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: CARPACCIO (CARboplatin PAClitaxel Cetuximab IO Immuno-oncology)
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.
Read the 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 the anti-cell death program-1 (PD-1) immunotherapy, pembrolizumab, improved significantly improved overall survival (OS) compared to the standard EXTREME regimen (platinum, 5-FU and cetuximab).
After this first line and in the absence of a randomized therapeutic trial, the therapeutic strategy is not known. Possible chemotherapies are paclitaxel or methotrexate.
Systemic treatment is indicated for patients with locoregional recurrence not eligible for radiotherapy or surgery with curative intent, or progression of distant metastatic disease.
Cetuximab is approved as a second-line treatment in the United States. For patients whose tumor progresses on pembrolizumab maintenance therapy with a platinum-free interval of at least 3 months, restarting platinum therapy is potentially effective. The combination of platinum with cetuximab and paclitaxel is then possible and potentially more effective than monotherapy, including in fragile patients.
The use of cetuximab in the second line appears all the more interesting since its use immediately after anti-PD-1 immunotherapy gives hope for a form of potentiation, as has been reported in several publications since 2020.
Very recently, the results of a French retrospective study evaluating the effectiveness of chemotherapy based on taxane + cetuximab +/- platinum in 99 patients with HNSCC tumor progression and locoregional or metastatic recurrence after immune checkpoint inhibitors was presented by the team of Peers from the Gustave Roussy Institute. They suggest that this combination was effective in this situation and deserved further investigation.
The only existing prospective study was reported during ASCO meeting in 2023. The Japanese team evaluated in a Phase II trial the efficacy of combining paclitaxel with cetuximab in 35 patients with R/M HNSCC after platinum-based chemotherapy and anti-PD1 immunotherapy. The ORR was 69.7%. The median progression-free survival was 5.6 months, and the overall survival was 13.4 months.
A multicenter retrospective study was presented at ESMO 2023. It analyzed the efficacy of paclitaxel alone (69 patients) and the combination of paclitaxel with cetuximab (83 patients) in patients with R/M HNSCC refractory to platinum-based chemotherapy, taxane-naive, and progressive under immune checkpoint inhibitors. An increase of ORR was assessed for the combination of paclitaxel and cetuximab. The median progression-free survival was 4.9 months, and the overall survival was 9.4 months.
Finally, in a study investigating the efficacy of paclitaxel and cetuximab in 57 patients with R/M HNSCC after failure of first-line treatment including an immune checkpoint inhibitor, the ORR was 47.4%. The median duration of response was 5.5 months and disease control was achieved in 42 patients, resulting in a DCR of 71.9%. The median PFS was 5.9 months and the median OS was 14.0 months. The 6-month PFS and OS rates were 48% and 74%, respectively.
- Conditions
- Head and Neck Cancer
- Being tested
- PCC
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCCDrug
PCC protocol (Paclitaxel - Carboplatin - Cetuximab) by intravenous injection for 16 cycles. 1 cycle lasts 1 week. The Carboplatin + Paclitaxel administration schedule 3 weeks out of 4, with weekly Cetuximab is authorized.
After 16 cycles: maintenance with Cetuximab 500 mg/m2 every 14 days until unacceptable toxicity or progression or death.
| Study group | Role | What they receive |
|---|---|---|
| PCC | Experimental | Not described Receives: Drug: PCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Best radiological response according to RECIST 1.1 criteria Number of patients who had an objective response within 12 months CT or MRI (PET scan is not validated for response evaluation) The evaluation is carried out by the investigator.
Measured: every 90 days up to 12 months
Secondary outcomes (6)
Progression-free survival
Progression events (loco-regional progression, metastatic progression or death whatever the cause) will be collected.
Measured: Every 90 days up to 12 months then according to local practices until the date of first documented progression or date of death from any cause or until 5 years, whichever came first
Overall survival
The patient's condition (alive, deceased from whatever cause or lost to follow-up) will be collected beyond 12 months of patient participation.
Patients alive at the time of analysis will be censored on the date of last contact
Measured: From date of treatment initiation until the date of death or lost to follow-up or until 5 years, whichever came first
Response duration
Time from date of first documented response (complete or partial response) to date of first subsequent progression or death from any cause
Measured: Every 90 days up to 12 months then according to local practices until the date of first documented progression or date of death from any cause or until 5 years, whichever came first
Patient Safety
Incidence of treatment-emergent adverse events, serious adverse events according to CTCAE V5.0 criteria and deaths
Measured: At 12 months
Patient Quality of life
Assessment of all dimensions of EORTC QLQ-C30 questionnaire
Measured: every 90 days up to 12 months
Patient Quality of life
Assessment of difference on specific symptom scales of EORTC QLQ-HN35 questionnaire
Measured: every 90 days up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start24 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, prospective, multicenter, open-label phase II study.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole PFLUMIO, MD, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725368
- Sponsor's protocol ID
- 2023-006
- Acronym
- CARPACCIO
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: CARPACCIO (CARboplatin PAClitaxel Cetuximab IO Immuno-oncology)
- ClinicalTrials.gov ID
- NCT06725368
- Acronym / sponsor ID
- CARPACCIO / 2023-006
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the anti-cell death program-1 (PD-1) immunotherapy, pembrolizumab, improved significantly improved overall survival (OS) compared to the standard EXTREME regimen (platinum, 5-FU and cetuximab).
After this first line and in the absence of a randomized therapeutic trial, the therapeutic strategy is not known. Possible chemotherapies are paclitaxel or methotrexate.
Systemic treatment is indicated for patients with locoregional recurrence not eligible for radiotherapy or surgery with curative intent, or progression of distant metastatic disease.
Cetuximab is approved as a second-line treatment in the United States. For patients whose tumor progresses on pembrolizumab maintenance therapy with a platinum-free interval of at least 3 months, restarting platinum therapy is potentially effective. The combination of platinum with cetuximab and paclitaxel is then possible and potentially more effective than monotherapy, including in fragile patients.
The use of cetuximab in the second line appears all the more interesting since its use immediately after anti-PD-1 immunotherapy gives hope for a form of potentiation, as has been reported in several publications since 2020.
Very recently, the results of a French retrospective study evaluating the effectiveness of chemotherapy based on taxane + cetuximab +/- platinum in 99 patients with HNSCC tumor progression and locoregional or metastatic recurrence after immune checkpoint inhibitors was presented by the team of Peers from the Gustave Roussy Institute. They suggest that this combination was effective in this situation and deserved further investigation.
The only existing prospective study was reported during ASCO meeting in 2023. The Japanese team evaluated in a Phase II trial the efficacy of combining paclitaxel with cetuximab in 35 patients with R/M HNSCC after platinum-based chemotherapy and anti-PD1 immunotherapy. The ORR was 69.7%. The median progression-free survival was 5.6 months, and the overall survival was 13.4 months.
A multicenter retrospective study was presented at ESMO 2023. It analyzed the efficacy of paclitaxel alone (69 patients) and the combination of paclitaxel with cetuximab (83 patients) in patients with R/M HNSCC refractory to platinum-based chemotherapy, taxane-naive, and progressive under immune checkpoint inhibitors. An increase of ORR was assessed for the combination of paclitaxel and cetuximab. The median progression-free survival was 4.9 months, and the overall survival was 9.4 months.
Finally, in a study investigating the efficacy of paclitaxel and cetuximab in 57 patients with R/M HNSCC after failure of first-line treatment including an immune checkpoint inhibitor, the ORR was 47.4%. The median duration of response was 5.5 months and disease control was achieved in 42 patients, resulting in a DCR of 71.9%. The median PFS was 5.9 months and the median OS was 14.0 months. The 6-month PFS and OS rates were 48% and 74%, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective, multicenter, open-label phase II study.
| Arm | Type | Receives |
|---|---|---|
| PCC | Experimental | Drug: PCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCCPCC protocol (Paclitaxel - Carboplatin - Cetuximab) by intravenous injection for 16 cycles. 1 cycle lasts 1 week. The Carboplatin + Paclitaxel administration schedule 3 weeks out of 4, with weekly Cetuximab is authorized. After 16 cycles: maintenance with Cetuximab 500 mg/m2 every 14 days until unacceptable toxicity or progression or death. | Drug | PCC |
Primary outcome
Objective Response Rate
Time frame: every 90 days up to 12 months
Best radiological response according to RECIST 1.1 criteria Number of patients who had an objective response within 12 months CT or MRI (PET scan is not validated for response evaluation) The evaluation is carried out by the investigator.
6 secondary outcomes
Progression-free survival
Time frame: Every 90 days up to 12 months then according to local practices until the date of first documented progression or date of death from any cause or until 5 years, whichever came first
Overall survival
Time frame: From date of treatment initiation until the date of death or lost to follow-up or until 5 years, whichever came first
Response duration
Time frame: Every 90 days up to 12 months then according to local practices until the date of first documented progression or date of death from any cause or until 5 years, whichever came first
Patient Safety
Time frame: At 12 months
Patient Quality of life
Time frame: every 90 days up to 12 months
Patient Quality of life
Time frame: every 90 days up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carole PFLUMIO, MD principal investigator
Centre Paul Strauss
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCC in people with Head and Neck Cancer, run by Centre Paul Strauss at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon VOEGELIN (3687339523 ext. +33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: every 90 days up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.