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

Phase 1

• Conditions: Recurrent/metastatic head and neck squamous cell carcinoma.; MedDRA version: 21.1Level: PTClassification code 10071540Term: Head and neck cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: 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-HU
• 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: 2015-02-20
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 825

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

- 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.

Study & Design

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