Therapy Detail

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Therapy Name Cetuximab
Synonyms
Therapy Description

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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 31 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600E rectum cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab), as a monotherapy, is not indicated for use in rectum cancer patients with BRAF V600E (NCCN.org). detail...
NRAS A146X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 4, codon 146 mutations is contraindicated (FDA.gov). detail...
NRAS G115Efs*46 colorectal cancer predicted - resistant Cetuximab Clinical Study - Cohort Actionable In a retrospective analysis, NRAS G115Efs*46 was identified at a frequency of >1% in 3 of 23 patients with metastatic colorectal cancer who did not respond to anti-EGFR therapy (Erbitux (cetuximab), n=12 or Vectibix (panitumumab), n=11), and was associated with a lack of response (p=0.029) to EGFR-targeted therapy (PMID: 32796636). 32796636
NRAS exon3 rectum cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab) is not indicated for use in rectum cancer patients with NRAS exon 3 mutations (NCCN.org). detail...
NRAS G13X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 2, codon 13 mutations is contraindicated (FDA.gov). detail...
NRAS K117X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 4, codon 117 mutations is contraindicated (FDA.gov). detail...
CTNNB1 S33P colorectal cancer resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, a colorectal cancer cell line expressing CTNNB1 S33P was resistant to treatment with Erbitux (cetuximab) in culture (PMID: 33574948). 33574948
NRAS wild-type colon cancer predicted - sensitive Cetuximab Guideline Actionable Erbitux (cetuximab), alone and in combination with chemotherapy, is included in guidelines for patients with advanced or metastatic colon cancer that is BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
BRAF wild-type rectum cancer predicted - sensitive Cetuximab Guideline Actionable Erbitux (cetuximab), alone and in combination with chemotherapy, is included in guidelines for patients with advanced or metastatic rectal cancer that is BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
NRAS exon4 rectum cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab) is not indicated for use in rectum cancer patients with NRAS exon 4 mutations (NCCN.org). detail...
PIK3CA E542V colorectal cancer predicted - sensitive Cetuximab Case Reports/Case Series Actionable In a retrospective analysis, Erbitux (cetuximab) treatment resulted in stable disease in a colorectal carcinoma patient harboring a PIK3CA E542V mutation (PMID: 25714871). 25714871
HRAS G12V Advanced Solid Tumor resistant Cetuximab Preclinical Actionable In a preclinical study, tumor cells expressing HRAS G12V demonstrated resistance to treatment with Erbitux (cetuximab) (PMID: 22797062). 22797062
MAP2K1 K57T colorectal cancer predicted - resistant Cetuximab Case Reports/Case Series Actionable In a clinical case study, a patient with colorectal cancer developed liver metastases harboring MAP2K1 K57T that were insensitive to Erbitux (cetuximab) treatment and the mutation was confirmed to cause resistance in human colorectal cancer cell lines in culture (PMID: 26644315). 26644315
MAP2K1 F53L colorectal cancer resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, expression of MAP2K1 F53L conferred resistance to Erbitux (cetuximab) in colorectal cancer cells in culture (PMID: 28179366). 28179366
NRAS exon2 rectum cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab) is not indicated for use in rectum cancer patients with NRAS exon 2 mutations (NCCN.org). detail...
NRAS Q61X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 3, codon 61 mutations is contraindicated (FDA.gov). detail...
PIK3CA H1047R colorectal cancer sensitive Cetuximab Case Reports/Case Series Actionable In a retrospective analysis, Erbitux (cetuximab) combined with radiation therapy resulted in stable disease for 6 months in a colorectal carcinoma patient harboring a PIK3CA H1047R mutation (PMID: 25714871). 25714871
BRAF V600E colon cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab), as a monotherapy, is not indicated for use in colon cancer patients with BRAF V600E (NCCN.org). detail...
BRAF G466V colorectal cancer sensitive Cetuximab Preclinical - Pdx Actionable In a preclinical study, treatment with Erbitux (cetuximab) reduced ERK signaling and resulted in tumor regression in a colorectal cancer patient-derived xenograft (PDX) model harboring BRAF G466V, and wild-type RAS and NF1 (PMID: 28783719). 28783719
BRAF G466V colorectal cancer sensitive Cetuximab Preclinical - Pdx Actionable In a preclinical study, Erbitux (cetuximab) treatment inhibited Erk signaling and reduced tumor growth in a patient-derived xenograft (PDX) model of colorectal cancer harboring BRAF G466V (PMID: 30559419). 30559419
PIK3CA H1047R head and neck squamous cell carcinoma resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, head and neck squamous cell carcinoma cells harboring PIK3CA H1047R were resistant to Erbitux (cetuximab) in culture (PMID: 30962319). 30962319
MAP2K1 C121S colorectal cancer resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, expression of MAP2K1 C121S conferred resistance to Erbitux (cetuximab) in colorectal cancer cells in culture (PMID: 28179366). 28179366
BRAF K601E colorectal cancer resistant Cetuximab Preclinical - Pdx Actionable In a preclinical study, Erbitux (cetuximab) treatment did not inhibit Erk signaling or reduce tumor growth in a patient-derived xenograft (PDX) model of colorectal cancer harboring BRAF K601E (PMID: 30559419). 30559419
PTEN positive head and neck squamous cell carcinoma predicted - sensitive Cetuximab Clinical Study - Cohort Actionable In a clinical study, high PTEN expression was associated with improved progression-free survival (HR=0.35, p=0.008) in head and neck squamous cell carcinoma patients treated with Erbitux (cetuximab) with or without Nexavar (sorafenib) (PMID: 30926065). 30926065
CTNNB1 T41A colorectal cancer resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, a colorectal cancer cell line expressing CTNNB1 T41A was resistant to treatment with Erbitux (cetuximab) in culture (PMID: 33574948). 33574948
NRAS wild-type rectum cancer predicted - sensitive Cetuximab Guideline Actionable Erbitux (cetuximab), alone and in combination with chemotherapy, is included in guidelines for patients with advanced or metastatic rectal cancer that is BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
BRAF V600E PIK3CA P449T colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, human colorectal cancer cells harboring BRAF V600E and PIK3CA P449T were resistant to Erbitux (cetuximab) in culture (PMID: 25838391). 25838391
PIK3CA mutant cervical cancer decreased response Cetuximab Phase II Actionable In a Phase II clinical trial, Erbitux (cetuximab) treatment, in addition to radiochemotherapy, did not result in any complete responses (0/8) and demonstrated a worse disease free survival when compared to radiochemotherapy alone in cervical cancer patients harboring PIK3CA mutations (PMID: 25724520). 25724520
CTNNB1 S45F colorectal cancer resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, a colorectal cancer cell line expressing CTNNB1 S45F was resistant to treatment with Erbitux (cetuximab) in culture (PMID: 33574948). 33574948
NRAS G12V colorectal cancer resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, colorectal cancer cells harboring NRAS G12V demonstrated resistance to Erbitux (cetuximab) in culture (PMID: 28179366). 28179366
NRAS exon4 colon cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab) is not indicated for use in colon cancer patients with NRAS exon 4 mutations (NCCN.org). detail...
NRAS A59X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 3, codon 59 mutations is contraindicated (FDA.gov). detail...
BRAF wild-type colon cancer predicted - sensitive Cetuximab Guideline Actionable Erbitux (cetuximab), alone and in combination with chemotherapy, is included in guidelines for patients with advanced or metastatic colon cancer that is BRAF wild-type, KRAS wild-type, and NRAS wild-type (NCCN.org). detail...
MAP2K1 K57N colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, colorectal cancer cell lines expressing MAP2K1 K57N were insensitive to Erbitux (cetuximab) in culture (PMID: 26644315). 26644315
NRAS exon2 colon cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab) is not indicated for use in colon cancer patients with NRAS exon 2 mutations (NCCN.org). detail...
NRAS exon3 colon cancer resistant Cetuximab Guideline Actionable Erbitux (cetuximab) is not indicated for use in colon cancer patients with NRAS exon 3 mutations (NCCN.org). detail...
NRAS G12X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 2, codon 12 mutations is contraindicated (FDA.gov). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04428151 Phase II Lenvatinib + Pembrolizumab Docetaxel Paclitaxel Capecitabine Cetuximab Lenvatinib Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) Recruiting USA | CAN 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
NCT00292955 Phase II Cetuximab Cisplatin Cetuximab, Cisplatin, and Radiotherapy in Women With Locally Advanced Cervical Carcinoma Unknown status USA 0
NCT03769311 Phase II Cetuximab Cetuximab in Head and Neck Cancer Patients Recruiting USA 0
NCT01309126 Phase III Cetuximab Cetuximab + PGG beta-glucan Study of Imprime PGG in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer Terminated USA 3
NCT01744340 Phase Ib/II Eribulin Cetuximab A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer Completed USA 0
NCT03258554 Phase II Cetuximab Durvalumab Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Stage III-IVB Head and Neck Cancer Who Cannot Take Cisplatin Suspended USA | CAN 0
NCT02105636 Phase III Methotrexate Cetuximab Docetaxel Nivolumab Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) Unknown status USA | CAN 13
NCT01979211 Phase II Cetuximab Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck Active, not recruiting USA 0
NCT03416153 Phase II Cetuximab Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer Recruiting USA 0
NCT00904345 Phase II Cetuximab Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC) Terminated USA 0
NCT04008030 Phase III Nivolumab Fluorouracil + Irinotecan + Leucovorin Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab Ipilimumab + Nivolumab A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Patients With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW)) Recruiting USA | CAN 22
NCT01025089 Phase II Cetuximab Cisplatin + Cyclophosphamide + Doxorubicin Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma Active, not recruiting USA 0
NCT02057107 Phase II Cetuximab Docetaxel Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN) Recruiting USA 0
NCT05041127 Phase II Cetuximab Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma Not yet recruiting USA 0
NCT01524978 Phase II Vemurafenib Cetuximab A Study of Zelboraf (Vemurafenib) in Patients With BRAF V600 Mutation-Positive Cancers Completed USA 5
NCT01104922 Phase II Cetuximab Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck Active, not recruiting USA 0
NCT02358031 Phase III Cetuximab Pembrolizumab Fluorouracil Carboplatin Cisplatin A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) Active, not recruiting 0
NCT01472016 Phase I Docetaxel ABT-700 Cetuximab Erlotinib Fluorouracil + Irinotecan + Leucovorin Study of ABT-700 in Subjects With Advanced Solid Tumors Completed 0
NCT01816984 Phase Ib/II Cetuximab Buparlisib PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Completed USA 0
NCT01652482 Phase II Cetuximab Duligotuzumab Fluorouracil + Irinotecan + Leucovorin A Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wild-Type Metastatic Colorectal Cancer Completed USA 9
NCT02252042 Phase III Pembrolizumab Methotrexate Cetuximab Docetaxel Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) Active, not recruiting 0
NCT00957853 Phase II Cetuximab Cixutumumab Preoperative Treatment With Cetuximab and/or IMC-A12 Completed 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 1
NCT02499120 Phase II Palbociclib Cetuximab Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer Unknown status USA 14
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 3
NCT04590963 Phase III Cetuximab Cetuximab + Monalizumab Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer (INTERLINK-1) Recruiting USA | CAN 23
NCT03387111 Phase Ib/II Capecitabine Nab-paclitaxel Leucovorin GI-6301 GI-6207 Avelumab ETBX-021 ETBX-051 ETBX-061 Aldoxorubicin Cisplatin Cyclophosphamide Bevacizumab Necitumumab GI-4000 Cetuximab ALT-803 Fluorouracil ETBX-011 Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy Active, not recruiting USA 0
NCT02800486 Phase II Cetuximab Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA Recruiting USA 0
NCT02281955 Phase II Cisplatin Carboplatin Cetuximab De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC Active, not recruiting USA 0
NCT01577173 Phase II Cetuximab Duligotuzumab A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck Completed USA 10
NCT04065555 Phase I Avelumab + TAK-981 Cetuximab Cetuximab + TAK-981 TAK-981 Avelumab Intratumoral Microdosing of TAK-981 in Head and Neck Cancer Recruiting USA 0
NCT01468896 Phase Ib/II Cetuximab Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery Active, not recruiting USA 0
NCT02324608 Phase I Cetuximab Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer Active, not recruiting USA 0
NCT01467115 Phase II Leucovorin Cisplatin + Docetaxel + Fluorouracil Filgrastim Cetuximab INDUCTION CHEMOTHERAPY FOLLOWED BY CETUXIMAB AND RADIATION THERAPY FOR HEAD AND NECK CANCER Completed USA 0
NCT03349710 Phase III Cetuximab Cisplatin Cetuximab + Nivolumab Cisplatin + Nivolumab Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer Completed USA 9
NCT01238237 Phase I Cetuximab Super-Selective Intraarterial Cerebral Infusion of Cetuximab for the Treatment of Recurrent Glioblastoma Multiforme and Anaplastic Astrocytoma 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 Not yet recruiting USA 0
NCT02124850 Phase I Cetuximab A Phase Ib Study of Neoadjuvant Immune Biomarker Modulation With ERBITUX® (Cetuximab) and VTX-2337 Terminated USA 0
NCT03693612 Phase Ib/II GSK3359609 + Tremelimumab Paclitaxel Docetaxel Cetuximab GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors Completed USA | CAN 1
NCT01218048 Phase II Cisplatin Carboplatin Cetuximab ERBITUX; Followed by Adjuvant Treatment With Chemoradiation and ERBITUX; for Locally Advanced Head and Neck Squamous Cell Carcinoma Completed USA 0
NCT04375384 Phase II Cetuximab Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy Recruiting USA 0
NCT01663259 Phase I Cetuximab Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients Completed USA 0
NCT03727061 Phase II Cisplatin + Fluorouracil Carboplatin + Fluorouracil Pembrolizumab Cetuximab Nivolumab Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer Recruiting USA 0
NCT01285037 Phase I Cisplatin Cetuximab Merestinib A Study of LY2801653 in Advanced 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 Recruiting USA 0
NCT00956007 Phase III Cetuximab Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer Active, not recruiting USA | CAN 2
NCT02555644 Phase I Prexasertib Cisplatin Cetuximab A Study of LY2606368 With Chemotherapy and Radiation in Participants With Head and Neck Cancer Completed USA 1


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