Therapy Detail

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Therapy Name Cetuximab + Irinotecan
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 57 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).
Irinotecan Camptosar CPT-11 TOPO1 inhibitor 11 Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF D594G colorectal cancer not predictive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with Camptosar (irinotecan) as a third-line therapy resulted in stable disease in two patients with metastatic colorectal cancer harboring BRAF D594G, with progression-free survival of 2.2 and 6.6 months (PMID: 31515458). 31515458
BRAF G469A colorectal cancer not predictive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with Camptosar (irinotecan) as a third-line therapy resulted in stable disease with a PFS of 3.5 months in a patient with metastatic colorectal cancer harboring BRAF G469A (PMID: 31515458). 31515458
MAP2K1 P124S colorectal cancer predicted - resistant Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical case study, a patient with KRAS/NRAS-wild-type colorectal cancer who progressed on treatment with Erbitux (cetuximab) and Camptosar (irinotecan) was found through ctDNA testing to have acquired MAP2K1 P124S, and preclinical analysis of colorectal cancer cells expressing MAP2K1 P124S demonstrated increased Erk phosphorylation upon treatment with Erbitux (cetuximab) in culture (PMID: 33322618). 33322618
BRAF N581I colorectal cancer not predictive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with Camptosar (irinotecan) as a first-line therapy resulted in stable disease with progression-free survival of 10.3 months in a patient with metastatic colorectal cancer harboring BRAF N581I (PMID: 31515458). 31515458
BRAF R558Q colorectal cancer not predictive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with Camptosar (irinotecan) as a fourth-line therapy resulted in a complete response with progression-free survival of 37.7 months in a patient with metastatic colorectal cancer harboring BRAF R558Q (PMID: 31515458). 31515458
PIK3CA E542K colorectal cancer predicted - sensitive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a retrospective analysis, treatment with the combination of Erbitux (cetuximab) and Camptosar (irinotecan) resulted in a partial response in 50% (1/2) and stable disease in 50% (1/2) of colorectal carcinoma patients harboring a PIK3CA E542K mutation (PMID: 25714871). 25714871
PIK3CA E545K colorectal cancer sensitive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a retrospective analysis, treatment with the combination of Erbitux (cetuximab) and Camptosar (irinotecan) resulted in stable disease in 50% (1/2) and 14 months without evidence of disease in 50% (1/2) of colorectal carcinoma patients harboring a PIK3CA E545K mutation (PMID: 25714871). 25714871
BRAF G469V colorectal cancer not predictive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with Camptosar (irinotecan) as a third-line therapy resulted in stable disease with progression-free survival of 10.9 months in a patient with metastatic colorectal cancer harboring BRAF G469V (PMID: 31515458). 31515458
BRAF L485F colorectal cancer not predictive Cetuximab + Irinotecan Case Reports/Case Series Actionable In a clinical study, the combination of Erbitux (cetuximab) with Camptosar (irinotecan) as a third-line therapy resulted in stable disease with progression-free survival of 6.3 months in a patient with metastatic colorectal cancer harboring BRAF L485F (PMID: 31515458). 31515458

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01910610 Phase III Cetuximab Irinotecan + Panitumumab Panitumumab Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1) Active, not recruiting FRA 2
NCT04189055 Phase II Cetuximab + Irinotecan Cetuximab Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases. (CETIDYL) Recruiting FRA 0
NCT03365882 Phase II Cetuximab + Irinotecan Pertuzumab + Trastuzumab S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Active, not recruiting USA 1
NCT00063141 Phase III Irinotecan Cetuximab + Irinotecan Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer Completed USA | NLD | ITA | GBR | FRA | DEU | BEL | AUT | AUS 8
NCT04587128 Phase II Cetuximab Cetuximab + Irinotecan Panitumumab Irinotecan + Panitumumab Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC Recruiting USA 0
NCT01079780 Phase II Cetuximab + Irinotecan + Ramucirumab Cetuximab + Irinotecan Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy Completed USA 0
NCT02292758 Phase II Bevacizumab + Cetuximab + Irinotecan Cetuximab + Irinotecan Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer Completed USA 0
NCT05312398 Phase II Cetuximab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Irinotecan Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen Active, not recruiting ITA 0
NCT02928224 Phase III Cetuximab + Encorafenib Binimetinib + Cetuximab + Encorafenib Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (BEACON CRC) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 16
NCT02164916 Phase II Cetuximab + Irinotecan Cetuximab + Irinotecan + Vemurafenib S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer Completed USA 0
NCT04117945 Phase II Regorafenib Irinotecan + Panitumumab Panitumumab Cetuximab + Irinotecan Cetuximab Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer Active, not recruiting USA 0


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