[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04375384":3,"trial-entities:NCT04375384":123,"trial-summary:NCT04375384":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":48,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":91,"locations":94,"central_contacts":112,"overall_officials":115,"references":117,"see_also_links":122},"NCT04375384","IRB00065239","Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer","Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma","RECRUITING","2027-12","2026-07","2026-07-17","2020-07-01","Wake Forest University Health Sciences","OTHER",true,"This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent\u002F metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.","Primary Objective:\n\n• To measure Overall Response Rate to treatment with Cetuximab as single agent in patients with recurrent or metastatic head and neck squamous cell cancer who failed PD-1 inhibitors alone or in combination with chemotherapy.\n\nSecondary Objective(s):\n\n* Measure Duration of Response (DUR), Progression Free Survival and Overall Survival and for treatment with single agent Cetuximab after immunotherapy with PD-1 inhibitors in Head and Neck Squamous Cell Carcinoma.\n* Evaluate treatment toxicity with single agent Cetuximab in this patient population.\n\nOUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 1 week and then every 6-8 weeks thereafter.",[19,20,21],"Head and Neck Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Metastatic Head-and-neck Squamous-cell Carcinoma",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},38,"ESTIMATED",[31,36,40],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Cetuximab","A loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg\u002Fm2 and will be infused over 2h followed by 1h observation.\n\nThe maintenance dose of Cetuximab is 250 mg\u002Fm2 and will be infused over 1h. No further observation time needed.\n\nThe maintenance dose of cetuximab will be given every 7 days (+\u002F- 2 days) starting 7 days (+\u002F- 2 days) after the loading dose of cetuximab.\n\nPre-medicate with 50 mg Diphenhydramine IV before the loading dose of Cetuximab and as per standard of care before the maintenance treatment.",[33],{"type":14,"name":37,"description":38,"armGroupLabels":39},"Questionnaire administration","Ancillary studies",[33],{"type":14,"name":41,"description":38,"armGroupLabels":42},"Quality of life assessment",[33],[44],{"measure":45,"description":46,"timeFrame":47},"Change in Overall Response Rate To Treatment with Cetuximab","Overall response rate is defined as the proportion patients achieving partial response or complete response per RECIST v1.1 criteria. An estimate of a 95% Exact Clopper Pearson confidence interval will be used. RECIST 1.1 criteria will be used to measure tumor size: Measurable disease is defined by the presence of at least 1 measurable lesion. A lesion, not previously irradiated per the protocol prior to enrollment, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and that is suitable for accurate repeated measurements. Non-measurable: All other lesions, including small lesions (longest diameter \\\u003C10 mm or pathological lymph nodes with ≥10 mm to \\\u003C15 mm short axis at baseline). Only participants with measurable disease at baseline will be included in the study.","14 days before start of treatment, 7 weeks after start of treatment, and then every 6-8 weeks for the duration of treatment, up to approximately 2 years.",[49,53,56,59],{"measure":50,"description":51,"timeFrame":52},"Duration of Progression Free Survival","Progression free survival will be defined as progression of local-regional disease, distant metastases or death without progression and will be reported as median progression-free survival as well as progression free survival at 6 month and 1 year time points. Investigators will estimate Kaplan Meier survival curves and estimate the median duration of response with 95% confidence intervals for these measures.","At 6 months and at 1 year after enrollment on study",{"measure":54,"description":55,"timeFrame":52},"Duration of Overall Survival","Overall survival is defined as death due to any cause and will be reported as median overall survival as well as overall survival at 6 month and 1 year time points. Investigators will estimate Kaplan Meier survival curves and estimate the median duration of response with 95% confidence intervals for these measures.",{"measure":57,"description":58,"timeFrame":52},"Duration of Response","Response is defined as (failure - progression of loco-regional disease or distant metastasis) Investigators will estimate Kaplan Meier survival curves and estimate the median duration of response and will also estimate 95% confidence intervals for this measure.",{"measure":60,"description":61,"timeFrame":62},"Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0","Treatment-related side effects will be collected before each treatment based on clinical laboratory and radiologic changes and will be graded and reported. All patients who receive at least one dose of cetuximab will be considered evaluable for safety analysis. Investigators will create frequency tables that count the number and severity of toxicities observed in this study.","Up to 2 years","ALL","18 Years",null,false,{"inclusion":68,"exclusion":76,"raw_text":90},[69,70,71,72,73,74,75],"Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.","Measurable disease by scans- at least one measurable lesion.","Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy.","Patients must have a Performance Status of 0-2.","Patients must be greater than or equal to 18 years old.","Participant is willing and able to comply with the protocol for the duration of the study.","Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.",[77,78,79,80,81,82,83,84,85,86,87,88,89],"Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years.","Prior allergic reaction to Cetuximab.","History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab.","Patients receiving any other investigational agents.","Patient is on medications that need to be continued and that might interact with Cetuximab.","Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures.","Participant with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging.","Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician","history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment","history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment","history of myocardial infarction, ventricular arrhythmia, stable\u002Funstable angina, -symptomatic congestive heart failure, coronary\u002Fperipheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment","history of arterial or venous thrombosis\u002Fthromboembolic event, including pulmonary embolism within 6 months of study enrollment","any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids.","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.\n* Measurable disease by scans- at least one measurable lesion.\n* Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy.\n* Patients must have a Performance Status of 0-2.\n* Patients must be greater than or equal to 18 years old.\n* Participant is willing and able to comply with the protocol for the duration of the study.\n* Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years.\n* Prior allergic reaction to Cetuximab.\n* History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab.\n* Patients receiving any other investigational agents.\n* Patient is on medications that need to be continued and that might interact with Cetuximab.\n* Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures.\n* Participant with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging.\n\nAny of the following conditions:\n\n* Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician\n* history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment\n* history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment\n* history of myocardial infarction, ventricular arrhythmia, stable\u002Funstable angina, -symptomatic congestive heart failure, coronary\u002Fperipheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment\n* history of arterial or venous thrombosis\u002Fthromboembolic event, including pulmonary embolism within 6 months of study enrollment\n* any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids.\n\nPregnancy, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":109},"Wake Forest Baptist Comprehensive Cancer Center","Winston-Salem","North Carolina","27157","United States",[102,106],{"name":103,"role":104,"email":105},"Ashley Fansler","CONTACT","Ashley.Fansler@Advocatehealth.org",{"name":107,"role":108},"Mercedes Porosnicu, MD","PRINCIPAL_INVESTIGATOR",{"lat":110,"lon":111},36.09986,-80.24422,[113],{"name":103,"role":104,"phone":114,"email":105},"13367133539",[116],{"name":107,"affiliation":13,"role":108},[118],{"pmid":119,"type":120,"citation":121},"38249330","DERIVED","Burcher KM, Bloomer CH, Gavrila E, Kalada JM, Chang MJ, Gebeyehu RR, Song AH, Khoury LM, Lycan TW, Kinney R, D'Agostino R Jr, Bunch PM, Shukla K, Triozzi P, Furdui CM, Zhang W, Porosnicu M. Study protocol: phase II study to evaluate the effect of cetuximab monotherapy after immunotherapy with PD-1 inhibitors in patients with head and neck squamous cell cancer. Ther Adv Med Oncol. 2024 Jan 19;16:17588359231217959. doi: 10.1177\u002F17588359231217959. eCollection 2024.",[],{"nct_id":4,"conditions":124,"biomarkers":125},[19],[],{"nct_id":4,"found":15,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is a Phase II, non-randomized, open-label study involving 38 participants.","completed","Cetuximab After Immunotherapy for Head and Neck Cancer","This study is looking at how well Cetuximab works in people with head and neck squamous cell carcinoma (a type of cancer that starts in flat cells lining the mouth, throat, or voice box) that has come back or spread. You might be able to join if you've already had immunotherapy (treatment that helps your immune system fight cancer) with a PD-1 inhibitor, either alone or with chemotherapy, and it didn't work or you couldn't tolerate it. The main goal is to see how many people respond to Cetuximab treatment. The study is currently unclear on its recruitment status and plans to enroll 38 participants.","After treatment, you will be followed up at 1 week and then every 6-8 weeks thereafter.",105,"You would receive Cetuximab intravenously once a week. You will have assessments before treatment, at 7 weeks, and then every 6-8 weeks for up to approximately 2 years.","Not stated in the trial record.",[33],"v2"]