None listed
Conditions
Interventions
1.Pembrolizumab (MK-3475), solution for injection, 200 mg every 3 weeks, IV
2.Pembrolizumab, solution for injection, 200 mg every 3 weeks + Platinum + 5FU
3.Cetuximab 400 mg/m2 initial dose foll
5FU is 1000 mg/m2 continuous from Day 1 to Day 4 Q3W)
Treatment on trial will continue until disease progression is confirmed by the central imaging vendor, unacceptable adverse event(s),intercurre
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Have histologically or cytologically-confirmed R/M HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx. Subjects may not have had prior systemic therapy administered in the recurrent or metastatic setting. Provide written informed consent Be ≥ 18 years of age Have measurable disease based on RECIST 1.1 Have a performance status of 0 or 1 (ECOG) Demonstrate adequate organ function Have results of HPV positivity for oropharyngeal cancer Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Female subjects of childbearing potential should have a negative blood pregnancy test within 72 hours prior to receiving the first dose of study medication. Female subjects 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 through 180 days after the last dose of study medication Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
Exclusion criteria
Exclusion criteria: Disease suitable for local therapy with curative intent Progressive disease within 6 months of completion of treatment for locoregionally advanced HNSCC Participating or participated and receiving an investigational agent or device within 4 weeks of 1st dose Diagnosis of immunodeficiency receiving systemic steroid or immunosuppressive therapy within 7 days prior to 1st dose Other malignancy that is progressing or requires treatment Active central nervous system metastases and/or carcinomatous meningitis Active autoimmune disease that required systemic treatment in past 2 years Evidence of active, non-infectious pneumonitis Active infection requiring systemic therapy History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results, interfere with participation, or not in the best interest of the subject Psychiatric or substance abuse disorders Pregnant or breastfeeding, or expecting to conceive or father children starting with the screening visit through 180 days after last dose Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 or participated in MK-3475 trials. Known history of HIV; known active Hepatitis B or C Received a live vaccine within 30 days of start of therapy Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval is given
Countries
Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Israel, Italy, Japan, Latovia, Malasya, Netherlands, Norway, Philippines, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed