head and neck cancer
Conditions
Interventions
Product Name: Pembrolizumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
CAS Number: 1374853-91-4
Current Sponsor code: MK-3475
Other descriptive name: Anti-PD-1 mono
Sponsors
Med. Univ. Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient has provided written informed consent prior to any studyrelated 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 • Documented progressive disease based on investigator assessment according to RECIST 1.1, following receipt of a cisplatin and/or carboplatin based regimen administered for recurrent and/or metastatic disease independent of whether patient progressed during or after platinum based therapy. Platinum therapy might have been administered either as part of induction chemotherapy (6 months), chemoradiation (6 months) or as first line systemic palliative chemotherapy (12 months). • Measurable disease according to RECIST 1.1. • The patient has a life expectancy of at least 3 months. • Has a performance status of 0 or 1 on the ECOG Performance Scale 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 11 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 (at least 6 months before study entry) • Nasopharyngeal carcinomas or salivary glands cancers are not eligible • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. • Has a known history of active TB (Bacillus Tuberculosis) • Hypersensitivity to pembrolizumab or any of its excipients. • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent. - Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. • 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 known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. • Has known history of, or any evidence of active, non-infectious pneumonitis. • 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 subject's participation for the full duration of the trial, or is not in the best interest of the subject 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 prescreening or screening visit through 120 days after the last dose of trial treatment. • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent. • Has a known history of Human Immunodeficiency Virus (HIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the Overall Response Rate (CR/PR) rate and Progression Free Survival (PFS) in patients treated with pembrolizumab plus docetaxel for recurrent or metastatic (R/M) HNSCC after platinum-based first-line therapy • To evaluate the safety of pembrolizumab in combination with docetaxel in subjects diagnosed with R/M HNSCC;Secondary Objective: • To describe Best Overall Response categories (CR, PR, SD, PD) in patients treated with pembrolizumab in combination with docetaxel in subjects diagnosed with R/M HNSCC after platinum-based first-line therapy • To describe individual duration of response over time • To evaluate changes in health-related quality-of-life assessments from baseline in subjects with R/M HNSCC using the EORTC QLQ C-30 and EORTC QLQ-H&N35. • To assess median Overall Survival (OS) in this patient population;Primary end point(s): - safety - response assessment - response duration;Timepoint(s) of evaluation of this end point: after 24 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: na | — |
Countries
Austria
Outcome results
None listed