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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in Overall Response Rate To Treatment with Cetuximab
Study Overview
Brief Summary
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 in patients with recurrent or metastatic head and neck squamous cell cancer who failed 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.
OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients must have a Performance Status of 0-
- •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.
Exclusion Criteria
- •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.
- •Any of the following conditions:
- •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/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.
Arms & Interventions
Cetuximab
Patients receive cetuximab IV over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
Intervention: Questionnaire administration (Other)
Cetuximab
Patients receive cetuximab IV over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
Intervention: Quality of life assessment (Other)
Cetuximab
Patients receive cetuximab IV over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
Intervention: Cetuximab (Drug)
Outcomes
Primary Outcomes
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 2 years.
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 \<10 mm or pathological lymph nodes with ≥10 mm to \<15 mm short axis at baseline). Only participants with measurable disease at baseline will be included in the study.
Secondary Outcomes
- Duration of Progression Free Survival(At 6 months and at 1 year after enrollment on study)
- Duration of Overall Survival(At 6 months and at 1 year after enrollment on study)
- Duration of Response(At 6 months and at 1 year after enrollment on study)
- Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0(Up to 2 years)