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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Regional Lutte Contre Le Cancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Nov 2024 → ongoing

Decision date (initial)

2024-10-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512297-96-01

ClinicalTrials.gov

NCT06725368

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 5

1. Progression-free survival
2. Overall Survival
3. Duration of response
4. Safety
5. Quality of life

Conditions and MedDRA coding

Head and neck squamous cell carcinoma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

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 second line after Immune checkpoint inhibitor with or without chemotherapy
7. Chemotherapy-free interval equal or greater than 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

Exclusion criteria 10

1. Other histology
2. Nasal, paranasal and nasopharyngeal cavities
3. Symptomatic or active brain parenchymal metastases or leptomeningeal tumors
4. Grade equal or greater than to 2 for neuropathy
5. 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
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
8. Known hypersensitivity to the active substance or excipient of the treatments under study
9. 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
10. Major surgery within 4 weeks (= 28 days) before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of patients who had an objective response within 12 months

Secondary endpoints 5

1. Progression events (loco-regional progression, metastatic progression or death whatever the cause) will be collected beyond 12 months of patient participation according to local practices.
2. 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
3. Time from date of first documented response (complete or partial response) to date of first subsequent progression or death from any cause
4. Incidence of treatment-emergent adverse events, serious adverse events according to CTCAE V5.0 criteria and deaths
5. Taking the QLQ-C30 and QLQ-HN35 questionnaires

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Regional Lutte Contre Le Cancer

Sponsor organisation

Centre Regional Lutte Contre Le Cancer

Address

3 Rue De La Porte De L Hopital

City

Strasbourg

Postcode

67000

Country

France

Scientific contact point

Organisation

Centre Regional Lutte Contre Le Cancer

Contact name

PFLUMIO

Public contact point

Organisation

Centre Regional Lutte Contre Le Cancer

Contact name

PFLUMIO

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications