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 45 | 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|Onivyde | TOPO1 inhibitor 10 | 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 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 |
| 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 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 19 |
| 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 | Recruiting | USA | 0 |
| 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) | Recruiting | FRA | 2 |
| 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 |
| 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 |
| 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 |
| 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 | Recruiting | ITA | 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 |
| 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 |
| 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 |
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