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

Phase 1

• Conditions: Recurrent/metastatic head and neck squamous cell carcinoma.; MedDRA version: 19.0Level: PTClassification code 10071540Term: Head and neck cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003698-41-NL
• Lead Sponsor: Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-05
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 780

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.
(600 subjects with any PD-L1 result will be enrolled first followed by 180 subjects who must have strongly positive PD-L1 expression)
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 620
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

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 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 prior malignancy with recurrence in the last 5 years.
Active autoimmune disease that has required systemic treatment in past 2 years.
Has evidence of active, non-infectious 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.
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified