Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03833167
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Squamous Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    400 mg IV infusion
  • Placebo — DRUG
    Placebo-matched IV infusion

Study Details

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

Key Dates

Start date
Apr 1, 2019
Status verified
Feb 2026
Primary completion
Jun 28, 2024
Completion
Jan 20, 2026

Study Design

Enrollment
450 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.
  • Placebo Comparator: Placebo
    Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.

Primary Outcome Measure

Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy [ Time Frame: Up to approximately 62 months ]

Locations (30)

FacilityCityStateZIPSite coordinators
University of South Alabama, Mitchell Cancer Institute ( Site 1562)MobileAlabama36604-
City of Hope Medical Center ( Site 1505)DuarteCalifornia91010-
UCSD Moores Cancer Center ( Site 1561)La JollaCalifornia92093-0698-
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)Los AngelesCalifornia90095-
University of California Davis Comprehensive Cancer Center ( Site 1560)SacramentoCalifornia95817-
Stanford University Medical Center ( Site 1503)StanfordCalifornia94305-
University of Colorado Cancer Center ( Site 1506)AuroraColorado80045-
Smilow Cancer Center at Yale-New Haven ( Site 1507)New HavenConnecticut06510-
Boca Raton Regional Hospital ( Site 1551)Boca RatonFlorida33486-
UF Health ( Site 1511)GainesvilleFlorida32608-
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)MiamiFlorida33136-
Winship Cancer Institute of Emory University ( Site 1512)AtlantaGeorgia30322-1013-
Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)IndianapolisIndiana46202-
University of Iowa Hospital and Clinics ( Site 1514)Iowa CityIowa52242-
University of Kentucky School of Medicine & Hospitals ( Site 1542)LexingtonKentucky40536-
Dana Farber Cancer Center ( Site 1519)BostonMassachusetts02215-
Massachusetts General Hospital ( Site 1518)BostonMassachusetts02114-
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)HackensackNew Jersey07601-
Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565)Lake SuccessNew York11042-
Icahn School of Medicine at Mount Sinai ( Site 1575)New YorkNew York10029-
Cleveland Clinic ( Site 1541)ClevelandOhio44195-
Providence Portland Medical Center ( Site 1530)PortlandOregon97213-
UPMC Hillman Cancer Center ( Site 1570)PittsburghPennsylvania15232-
MUSC Hollings Cancer Center ( Site 1533)CharlestonSouth Carolina29425-
West Cancer Center - East Campus ( Site 1535)GermantownTennessee38138-
Vanderbilt Ingram Cancer Center ( Site 1543)NashvilleTennessee37232-
The University of Texas-MD Anderson Cancer Center ( Site 1536)HoustonTexas77030-
Huntsman Cancer Institute ( Site 1537)Salt Lake CityUtah84112-
Inova Schar Cancer Institute ( Site 1538)FairfaxVirginia22031-
West Virginia University ( Site 1569)MorgantownWest Virginia26506-

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Find similar trials in Mobile, AL

By research site
University of South Alabama, Mitchell Cancer Institute· Mobile, ALCity of Hope Medical Center· Duarte, CAUCSD Moores Cancer Center· La Jolla, CAUCLA Hematology/Oncology - Westwood (Building 100)· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAStanford University Medical Center· Stanford, CA

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