Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.

Not Applicable

Recruiting

• Conditions: -C760 Head, face and neck; Head, face and neck; C760

• Registration Number: PER-016-15
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-05
• Study Completion: 2016-12-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified