A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630) - Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites570 target enrollmentDecember 19, 2018

ConditionsResectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)MedDRA version: 20.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA (pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Resectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 570
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 19, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Participants must have histologically confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
•2\. Participant must have undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. Surgery may consist of 1 or a combination of the following:
•a. Resection of the primary lesion
•b. Any type of neck dissection(s)
•c. Any type of parotidectomy (superficial, total, partial)
•3\. Participant must have histologically confirmed LA cSCC with a high\-risk feature(s) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
•High\-risk features include at least 1 of the following:
•a) Histologically involved nodal disease that has at least 1 of the following features:
•Any extracapsular extension
•\=3 regional lymph nodes per primary site (affected regional sites and associated draining lymph nodes)

Exclusion Criteria

•1\. Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
•2\. Has any other histologic type of skin cancer other than invasive cSCC, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen’s disease, MCC, melanoma
•3\. A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
•4\. Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti\-PD\-L2 agent or with an agent directed to another costimulatory or co\-inhibitory T\-cell receptor (eg, CTLA\-4, OX\-40, CD137\)
•5\. Has received prior systemic anticancer therapy including investigational agents for cSCC within 4 weeks prior to randomization
•6\. Participant must have recovered from all radiation\-related toxicities, not have required corticosteroids, and not have had radiation pneumonitis
•7\. Has received a live vaccine within 30 days prior to the first dose of study treatment.Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
•8\. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
•9\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
•10\. Has a diagnosed and/or treated additional malignancy within the past 5 years prior to randomization