Recurrent and/or metastatic head and neck cancer MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10071540 Term: Head and neck cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Med. Univ. Wien, Klinik f. Innere Med. I, Onkologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient has provided written informed consent prior to any study-related procedure. · The patient is at least 18 years of age - Histologically proven locally advanced unresectable, recurrent and/or metastatic squamous cell carcinoma of the oropharynx, hypopharynx, larynx or oral cavity not amenable for salvage surgery · p16 status has to be determined for oropharyngeal carcinomas · Documented progressive disease based on investigator assessment according to RECIST 1.1, following receipt of a pembrolizumab based regimen given as first line therapy in the platinum sensitive setting (i.e. = 6 months since last platinum exposure) for recurrent and/or metastatic SCCHN · Measurable disease according to RECIST 1.1. · The patient has a life expectancy of at least 3 months. · Has a performance status of 0, 1 or 2 on the ECOG Performance Scale · Female patient of childbearing potential should have a negative Urine or serum pregnancy 24 hours prior to treatment initiation If the Urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. · Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study until 120 days after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. · Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy until 120 days after the last dose of study therapy. · Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 14 days of Treatment Initiation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Prior taxane therapy is not allowed except as part of induction therapy for locally advanced disease (completed at least 6 months before study entry) · Prior cetuximab therapy is not allowed except as part of either induction therapy or in combination with radiotherapy treatment for locally advanced disease (completed at least 6 months before study entry) · Patients with nasopharyngeal carcinomas or salivary glands cancers · Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment. · Has a diagnosis of immunodeficiency including a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). · Has known active Hepatitis A/B or Hepatitis C · Has had prior pembrolizumab within 1 week prior to study day 1 or who has not recovered (i.e., recovery to = Grade 1 or baseline grade prior to pembrolizumab) from (immune- related) adverse events other than endocrine side effects. · Has had prior chemotherapy or radiation therapy within 2 weeks Prior to study day 1 or who has not recovered (i.e., recovery to = Grade 1 or baseline grade prior to pembrolizumab) from adverse events due to a previously administered agent. · Has had chemotherapy, targeted therapy or investigational drugs after checkpoint inhibitor failure for second line therapy. - Has had prior pembrolizumab in the platinum resistant setting (<6 months after last platinum exposure). · Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the Skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. · Has an active infection requiring systemic therapy. · Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. · Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. · Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit until 120 days after the last dose of trial treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the confirmed Overall Response Rate (CR/PR) rate according to RECIST V 1.1, in patients treated with cetuximab plus paclitaxel for recurrent and/or metastatic SCCHN after pembrolizumab based first-line therapy;Secondary Objective: - To describe Best Overall Response categories (CR, PR, SD, PD) according to RECIST V 1.1, in patients treated with cetuximab in combination with paclitaxel in patients diagnosed with recurrent and/or metastatic SCCHN after pembrolizumab based first-line therapy · To describe duration of response · To evaluate changes in health-related quality-of-life assessments from baseline in patients with R/M SCCHN using the EORTC QLQ C-30 and EORTC QLQ-H&N35 questionnaires. · To assess median Overall Survival (OS) and Progression Free Survival (PFS) in this patient population · To evaluate the safety of cetuximab in combination with paclitaxel in patients diagnosed with recurrent and/or metastatic SCCHN.;Primary end point(s): Safety, response assessment and duration, EORTC QLQ-C30 and EORTC QLQ-H&N35;Timepoint(s) of evaluation of this end point: Disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: na | — |
Countries
Austria, Germany
Contacts
Public ContactSponsor-Investigator
Med. Univ. Wien, Klinik f. Innere Med. I, Onkologie
Outcome results
None listed