Phase 2, open-label, multicentre, single-arm study to evaluate the activity of the combination of EGFR inhibitors and c-MET inhibitors in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy.
Key facts
- Where
- Bologna, Brescia, Florence, Genoa, Milan, Milano, Padova, Pavia és Rome, OlaszországSee the 11 sites
- Phase
- 2. fázis
Where in Olaszország
- Ospedale Bellaria - Azienda USL di BolognaBologna, OlaszországToborzás még nem indult
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországToborzás még nem indult
- Azienda Ospedaliero-Universitaria CareggiFlorence, OlaszországToborzás még nem indult
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországToborzás még nem indult
- Humanitas Mirasole S.p.A.Milan, OlaszországToborzás még nem indult
- Istituto Europeo di Oncologia s.r.lMilan, OlaszországToborzás még nem indult
- Istituto Nazionale dei TumoriMilano, OlaszországToborzás még nem indult
- Istituto Oncologico VenetoPadova, OlaszországToborzás még nem indult
- Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. SbPavia, OlaszországToborzás még nem indult
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországToborzás még nem indult
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Trial code
- EU 2024-518892-72-00
- Record updated
- 2026. június 12.
- Original description
To evaluate the activity of tepotinib in combination with cetuximab in terms of tumor responseRead full original descriptionShow less
To evaluate the activity of tepotinib in combination with cetuximab in terms of tumor response
Inclusion: Adults >= 18 years old; 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.
Exclusion: 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 =< 2 peripheral neuropathy, grade =< 2 cetuximab-related rash or other skin changes, hypomagnesemia (acceptable values detailed below), hypokalemia (acceptable values detailed below), and the acceptable hematologic values summarized above; a washout period of 3 weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required; Previous treatment with cetuximab for RM disease. Use of cetuximab is allowed if given concurrently with radiation; History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agen; Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis; Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.