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 58 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 13 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
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
NCT05226871 Phase II Letrozole + Palbociclib Cetuximab + Palbociclib Cetuximab Fulvestrant + Palbociclib Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies Recruiting USA 3
NCT03446157 Phase II Cetuximab + Palbociclib Palbociclib and Cetuximab in Metastatic Colorectal Cancer Active, not recruiting USA 0
NCT02101034 Phase Ib/II Cetuximab + Palbociclib PD 0332991 and Cetuximab in Patients With Incurable SCCHN Completed USA 0
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


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