Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Nonproprietary name: MK-3475
Experimental: Pembrolizumab
Pharmacological classification code: 429 Other antitumor drugs
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-
plus cisplatin 100 mg/m^2 IV on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months])
plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Nonproprietary name: MK-3475, Carboplatin, 5-FU
Experimental: Pembrolizumab, Carboplatin,
plus carboplatin at a target area under the curve of 5 (AUC 5) IV on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months])
plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Nonproprietary name: Cetuximab
Experimental: Cetuximab
Pharmacological classification cod
plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy)
plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months])
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically- or cytologically-confirmed recurrent or metastatic head and neck squamous cell carcinoma considered incurable by local therapies - No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease) - Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology) 2.Measurable disease 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4.Adequate organ function 5.Can provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable. Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer 6.Female participants of childbearing potential should have a negative pregnancy test and must 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 7.Male participants must agree to use an adequate method of contraception starting with the first dose of study medication through 180 days after the last dose of study medication
Exclusion criteria
Exclusion criteria: 1.Disease suitable for local therapy administered with curative intent 2.Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC 3.Currently participating and receiving study therapy, or 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 study medication 4.Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication (physiologic doses of corticosteroids may be approved after consultation with the Sponsor) 5.Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers 6.Active central nervous system metastases and/or carcinomatous meningitis 7.Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment 8.History of (non-infectious) pneumonitis that required steroids or current pneumonitis 9.Active infection requiring systemic therapy 10.Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 11.Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study medication 12.Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or previously participated in Merck MK-3475 clinical trial 13.Known history of human immunodeficiency virus (HIV) 14.Known active Hepatitis B or C 15.Received a live vaccine within 30 days of planned start of study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) >=1 PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS >=20 Overall Survival (OS) in All Participants OS in Participants With PD-L1 CPS >=1 OS in Participants With PD-L1 CPS >=20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS >=1 Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS >=20 Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS >=1 Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS >=20 Objective Response Rate (ORR) Per RECIST 1.1 by BICR in All Participants ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS >=1 ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS >=20 Change From Baseline to Week 15 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score Time to Deterioration (TTD) in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Kaplan-Meier Method) | — |
Countries
Argentina, Australia, Austria, Brazil, Chile, Colombia, Czechia, Denmark, Estonia, Finland, Hong Kong, Israel, Italy, Latvia, Malaysia, Mexico, Netherland, Norway, Peru, Philippines, Refer to 7-5, Romania, Russia, Singapore, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkiye
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed