Clinical Trials /

Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy

NCT04375384

Description:

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/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: IRB00065239
  • SECONDARY ID: WFBCCC 60220
  • SECONDARY ID: P30CA012197
  • NCT ID: NCT04375384

Conditions

  • Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions

DrugSynonymsArms
CetuximabCetuximab

Purpose

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/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

Detailed Description

      Primary Objective:

      • To measure Overall Response Rate to treatment with Cetuximab as single agent following
      treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy.

      Secondary Objective(s):

        -  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.

        -  Evaluate treatment toxicity with single agent Cetuximab in this patient population.
    

Trial Arms

NameTypeDescriptionInterventions
CetuximabExperimentalA loading dose of Cetuximab will be administered in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation.
  • Cetuximab

Eligibility Criteria

        Inclusion Criteria:

          -  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 in the last 6 months.

          -  Patients must have a Performance Status of 0-2.

          -  Patients must be greater than or equal to 18 years old.

          -  Willing to provide consent for collection of samples of blood and saliva as scheduled
             through the treatment.

          -  Subject is willing and able to comply with the protocol for the duration of the study.

          -  Willingness to donate 2 tablespoons of blood and one teaspoon of saliva before
             treatment, 4 times during the first 6 weeks of treatment and then every 6-8 weeks
             while patients is under treatment.

          -  Ability to understand and the willingness to sign an Institutional Review
             Board-approved informed consent document.

        Exclusion Criteria:

          -  Prior treatment with Cetuximab or prior therapy that specifically and directly targets
             the epidermal growth factor receptor (EGFR) pathway.

          -  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.

          -  Subject with a history of interstitial lung disease (e.g. pneumonitis or pulmonary
             fibrosis) or evidence of interstitial lung disease on screening chest CT scan.

          -  Any of the following conditions: Serious or non-healing wound, ulcer, or bone
             fracture, 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/unstable
             angina, -symptomatic congestive heart failure, coronary/peripheral artery bypass graft
             or stenting or other significant cardiac disease within 6 months prior to study
             enrollment, history of arterial or venous thrombosis/thromboembolic 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.

          -  Pregnancy, 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in Overall Response Rate To Treatment with Cetuximab
Time Frame: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 1 year.
Safety Issue:
Description:Response to treatment with Cetuximab as a single agent following treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy will be assessed with CT scan or MRI at the discretion of the treating physician within 14 days +/- 7 days before starting treatment and then every six weeks through the treatment. 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 <10 mm or pathological lymph nodes with ≥10 mm to <15 mm short axis at baseline).

Secondary Outcome Measures

Measure:Duration of Progression Free Survival
Time Frame:At 6 months and at 1 year after enrollment on study
Safety Issue:
Description: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.
Measure:Duration of Overall Survival
Time Frame:At 6 months and at 1 year after enrollment on study
Safety Issue:
Description: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:Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame:Up to one week after last dose of study drug is administered
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Wake Forest University Health Sciences

Last Updated

May 4, 2020