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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 65	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, and in combination with Braftovi (encorafenib) with or without mFOLFOX6 in patients with metastatic colorectal cancer with BRAF V600E (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
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
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
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

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