CETUXIMAB SAROTALOCAN for Recurrent squamous cell carcinoma of the head and neck

Inclusion criteria

• {"criterion_text":"- Provision of written informed consent."}
• {"criterion_text":"- Male or female patients aged ≥18 years at the time of informed consent."}
• {"criterion_text":"- Histologically or cytologically confirmed squamous cell carcinoma of the primary site in the head or neck region (according to the American Joint Committee on Cancer [AJCC] classification), excluding nasopharyngeal carcinoma or cutaneous squamous cell carcinoma (cSCC). For confirmation of squamous cell carcinoma diagnosis, a pathology report must be provided for both the primary tumour and recurrence."}
• {"criterion_text":"- In the investigator’s opinion, patients must be eligible for standard first-line therapy with pembrolizumab ± chemotherapy for recurrent head and neck cancer."}
• {"criterion_text":"- No documented cases of distant metastases (M1 stage according to AJCC 8th edition)"}
• {"criterion_text":"- Presence of at least one lesion suitable for illumination with PIT (photoimmunotherapy) and measurable according to RECIST 1.1 criteria (by investigator’s assessment). Lesions in previously illuminated areas are considered measurable if progression is documented. • Lesions suitable for PIT illumination must be located in an area accessible to superficial or interstitial illumination. • These may be superficial lesions (for superficial illumination) or deep lesions (for interstitial illumination). • Lesions not suitable for PIT illumination include tumours requiring fibre insertion through bone (except tumours in paranasal sinuses), or tumours directly adjacent to / involving arteries, major veins, the orbit/eyeball, dura mater, or brain (including perineural invasion to the skull base)."}
• {"criterion_text":"- Patients who have not previously received anti–PD-1 or anti–PD-L1 therapy."}
• {"criterion_text":"- CPS greater or equal to 1, determined locally using an FDA-approved test."}

Exclusion criteria

• {"criterion_text":"- Diagnosis and/or treatment of another malignancy within 2 years prior to randomisation, except for diseases with minimal risk of metastasis or death (e.g., adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of another malignancy that was completely surgically removed and shows no evidence of recurrence may be eligible after consultation with the sponsor’s medical monitor."}
• {"criterion_text":"- Patients with a history of significant (grade ≥3) infusion reactions to cetuximab."}
• {"criterion_text":"- Prior allogeneic transplantation of tissues/solid organs."}
• {"criterion_text":"- Presence of or active metastases to the central nervous system and/or carcinomatous meningitis."}
• {"criterion_text":"- Estimated life expectancy less than 3 months."}
• {"criterion_text":"- Active autoimmune disease requiring systemic treatment within the past 2 years (i.e., use of immunosuppressive therapy including corticosteroids or disease-modifying agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment.\n\nUWAGA: Pacjenci z cukrzycą typu I lub niedoczynnością tarczycy wymagającą hormonalnej terapii zastępczej, zaburzeniami skórnymi (np. bielactwem nabytym, łuszczycą lub łysieniem) niewymagający leczenia ogólnoustrojowego lub schorzeniami, które nie powinny nawracać przy braku zewnętrznego czynnika wyzwalającego, nie są wykluczeni z udziału w badaniu."}
• {"criterion_text":"- Evidence of interstitial lung disease or active non-infectious pneumonitis."}

Primary endpoints

• {"endpoint_text":"- Overall Survival (OS): OS is defined as the time from randomisation to death from any cause.","definition_or_measurement_approach":"OS is defined as the time from randomisation to death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Key Secondary: • Complete Response Rate: CRR is defined as the proportion of patients with best overall response of confirmed CR per modified RECIST 1.1 as assessed by central reviewer. • Objective Response Rate: ORR is defined as the proportion of patients with best overall response of confirmed CR or confirmed PR per modified RECIST 1.1 as assessed by central reviewer.","definition_or_measurement_approach":"Complete Response Rate (CRR): proportion with best overall response of confirmed CR per modified RECIST 1.1 assessed by central reviewer. Objective Response Rate (ORR): proportion with best overall response of confirmed CR or confirmed PR per modified RECIST 1.1 assessed by central reviewer."}

Poland

Earliest CTIS Part Ii Submission Date

04-03-2026

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

42

Number Of Sites

4

Number Of Participants

30

Primary sponsor

Full Name

Rakuten Medical Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Biorasi GmbH

Responsibilities

sponsorDuties codes: 1,12,5,6,8

Name

Almac Clinical Services Limited

Responsibilities

sponsorDuties code: 14

Name

Bioclinica Inc.

Responsibilities

Collection/evaluation and central review of images (sponsorDuties code: 15)

Name

Precision For Medicine Inc.

Responsibilities

sponsorDuties code: 4

Name

Celerion Inc.

Responsibilities

sponsorDuties code: 4

Name

Corex Logistics Limited

Responsibilities

sponsorDuties code: 14

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties code: 6

Name

Suvoda LLC

Responsibilities

eCOA and eConsent (electronic assessments and electronic informed consent); sponsorDuties code: 3

Third parties

• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"eCOA (electronic assessment of clinical outcomes), eConsent (Electronic Informed Consent); sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Collection/evaluation and central review of images (sponsorDuties code: 15, value provided)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Biorasi GmbH","duties_or_roles":"sponsorDuties codes: 1,12,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Corex Logistics Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Nespat Corp.","duties_or_roles":"sponsorDuties code: 15 (Patient reimbursement)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}