in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy “ MedDRA version: 21.1 Level: PT Classification code 10028997 Term: Neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TEPMETKO
Product Name: TEPMETKO
Product Code: [TEPMETKO]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tepotinib
Current Sponsor code: tepotinib
Other descriptive name: tepo
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults > 18 years old - Patients must have histologically confirmed HNSCC from any primary site; nasopharyngeal carcinoma and paranasal sinus, will be included; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included - Recurrent/metastatic disease, fulfilling at least one of the criteria defined below: a) Incurable disease as assessed by surgical or radiation oncology b) Metastatic (M1) disease c) Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible - For patients with oropharyngeal primary site or unknown primary site only: tumoral human papillomavirus (HPV) status must be negative, as established; acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV deoxyribonucleic acid (DNA) For patients with nasopharyngeal cancer only or unknown primary site only: tumoral Epstein- Barr Virus (EBV) status must be negative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent; - Prior treatment with a hepatocyte growth factor (HGF)/cMet inhibitor such as rilotumumab, crizotinib, MetMAb, or ARQ197; - Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases, are not allowed; subjects with previously treated brain metastases will be allowed if the brain metastases have been stable without steroid treatment for at least 2 weeks (radiotherapy or surgery); - Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of: alopecia, grade == grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of tepotinib in combination with cetuximab in terms of tumor response;Secondary Objective: To further evaluate the activity of the combination of tepotinib and cetuximab in terms of: * duration of response (DoR) and disease control rate (DCR) * progression-free survival (PFS) * overall survival (OS) To evaluate the safety and tolerability of tepotinib in combination with cetuximab Impact on Quality of Life (QoL);Primary end point(s): Objective response (OR, confirmed complete response [CR] or partial response [PR]) determined according to RECIST Version 1.1 assessed by the Investigators;Timepoint(s) of evaluation of this end point: Complete Response (CR) defined as at least two determinations of CR at least 4 weeks apart (with no PD in between) Partial Response (PR) defined as at least two determinations of PR or better (PRfollowed by PR or PR followed by CR) at least 4 weeks apart (and not qualifying for a CR), with no PD in between Stable Disease (SD) defined as at least one SD assessment (or better)[= 6 weeks] after start date (and not qualifying for confirmed CR or PR. Non-CR/non-PD (applicable only to participants with non- measurable disease at Baseline) = at least one non-CR/non-PD assessment (or better) [= 6 weeks] afterstart date (and not qualifying for CR or PR). PD = PD = 12 weeks after start date (and not qualifying for CR, PR, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): DoR and DCR according to RECIST 1.1 as assessed by the Investigators. ° PFS ° OS; To evaluate the safety and tolerability of tepotinib incombination with cetuximab; Impact on Quality of Life (QoL);Timepoint(s) of evaluation of this end point: 3, 6, 9, 12,15, and 18 months; every time; Pre- study (within 2 weeks of study registration) and Week 9, Cycle 3 of Intervention] | — |
Countries
Italy
Contacts
Public Contactcoordinamento ricerca
asst degli Spedali Civili di Brescia
Outcome results
None listed