Recurrent/metastatic head and neck squamous cell carcinoma. 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) MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Cla
Conditions
Sponsors
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies. - Have measurable disease based on RECIST 1.1 as determined by the site. - Have a performance status of 0 or 1 on the ECOG Performance Scale. - Have results from local testing of HPV positivity for oropharyngeal cancer defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cut off point. - Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy. Repeat samples may be required if adequate tissue is not provided. A newly obtained biopsy (within 90 days prior to start of study treatment) is strongly preferred, but an archival sample is acceptable. 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 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 175
Exclusion criteria
Exclusion criteria: - Has disease that is suitable for local therapy administered with curative intent. - Has progressive disease within six months of completion of curatively intended treatment for locoregionally advanced HNSCC. - Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or not fully recovered from AE due to previous treatment. - Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator. - 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. Corticosteroid use as pre-medication for allergic reactions (e.g. IV contrast), or as a prophylactic management of adverse events related to the chemotherapies specified in the protocol is allowed. - Has a known history of prior malignancy with recurrence in the last 5 years. - Active autoimmune disease that has required systemic treatment in past 2 years. - Has had an allogeneic tissue/solid organ transplan. - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials. - Has an active infection requiring systemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) in first line recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects , treated with pembrolizumab monotherapy versus standard treatment 2) To compare PFS per RECIST 1.1 as assessed by BICR in first line R/M HNSCC subjects, treated with pembrolizumab in combination with chemotherapy versus standard treatment. 3) To evaluate the overall survival (OS) in first line R/M HNSCC subjects, treated with pembrolizumab monotherapy versus standard treatment. 4) To evaluate the OS in first line R/M HNSCC subjects, treated with pembrolizumab in combination with chemotherapy versus standard treatment. ;Secondary Objective: ;Primary end point(s): - Progression-free survival (PFS) - RECIST 1.1 by BICR - Overall Survival;Timepoint(s) of evaluation of this end point: 1. Progression-free-survival is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. 2. Overall Survival is defined as the time from randomization to death due to any cause. Subjects without documented death at the time of the final analysis will be censored at the date of the last follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion progression free at 6 months and 12 months – RECIST 1.1 by BICR - Objective Response Rate (ORR) – RECIST 1.1 by BICR - Duration of Response (DOR) – RECIST 1.1 by BICR;Timepoint(s) of evaluation of this end point: 1. The proportion progression free at 6 months and at 12 months is defined as the Kaplan-Meier estimate of the survival function for PFS at 6 months and 12 months, respectively. The progression-free status is based upon BICR per RECIST 1.1. 2. Objective response rate is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based upon BICR per RECIST 1.1. 3. For subjects who demonstrated CR or PR, duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first. | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactFan Jin
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
Outcome results
None listed