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

NCT06725368 | Recruiting Phase 2

• 1 other identifier: 2023-006
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  every 90 days up to 12 months

Secondary Outcomes (6)

• Progression-free survival

  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

  From date of treatment initiation until the date of death or lost to follow-up or until 5 years, whichever came first

• Response duration

  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

  At 12 months

• Patient Quality of life

  every 90 days up to 12 months

Study Arms (1)

PCC

EXPERIMENTAL

Drug: PCC

Interventions

PCC DRUG

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.

PCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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, 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

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (5)

Centre hospitalier Régional de Metz-Thionville

Ars-Laquenexy, 57085, France

RECRUITING

CHU de Besançon

Besançon, France

RECRUITING

Centre Hospitalier de Colmar

Colmar, 68024, France

RECRUITING

Centre Paul Strauss

Strasbourg, 67033, France

RECRUITING

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Carole PFLUMIO, MD

  Centre Paul Strauss

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon VOEGELIN

CONTACT

3687339523; promotion-rc@icans.eu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, prospective, multicenter, open-label phase II study.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 10, 2024
• Study Start: January 24, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2032
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (5)