Therapy Detail
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| Therapy Name | Cetuximab + Palbociclib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cetuximab | Erbitux | IMC-C225 | EGFR Antibody 60 | Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR positive colorectal cancer (FDA.gov). |
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CDKN2A negative | head and neck squamous cell carcinoma | predicted - sensitive | Cetuximab + Palbociclib | Case Reports/Case Series | Actionable | In a Phase I trial, Erbitux (cetuximab) and Ibrance (palbociclib) combination therapy was safe and resulted in a disease control rate of 89% (8/9, 2 partial responses, 6 stable disease) in patients with recurrent or metastatic head and neck squamous cell carcinoma, both responders had CDKN2A-negative tumors (PMID: 27311401). | 27311401 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03446157 | Phase II | Cetuximab + Palbociclib | Palbociclib and Cetuximab in Metastatic Colorectal Cancer | Active, not recruiting | USA | 0 |
| NCT05226871 | Phase II | Letrozole + Palbociclib Cetuximab + Palbociclib Cetuximab Fulvestrant + Palbociclib | Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies | Recruiting | USA | 6 |
| NCT04966481 | Phase III | Cetuximab + Palbociclib Cetuximab | Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor | Recruiting | USA | 0 |
| NCT02101034 | Phase Ib/II | Cetuximab + Palbociclib | PD 0332991 and Cetuximab in Patients With Incurable SCCHN | Completed | USA | 0 |
| NCT03389477 | Phase II | Cisplatin + Palbociclib Cetuximab + Palbociclib | Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma | Active, not recruiting | USA | 0 |
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