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

StatusTerminated
PhasePhase 3
Started2019-04-01
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 186 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-29
Reclassified as terminated (was completed)
Trial terminated: The study stopped due to futility
2026-02-17
Active, Not Recruiting→Completed Study Status v185
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2026-01-19→confirmed 2026-01-20
2025-12-05
Study Status v184
Completion date2025-12-22→2026-01-19
2025-07-19
Study Status, Adverse Events v183
Results first postednot stated→2025-07-22
2025-06-17
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v182
Secondary endpoints5 entries, revised
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Show 45 earlier versions
2025-06-12
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v181
InterventionsPembrolizumab 400 mg (Biological), Placebo (Drug)→Pembrolizumab (Biological), Placebo (Drug)
Eligibility criteria+157 characters
Inclusion Criteria: Inclusion Criteria include, but are not limited to: Has histologically confirmed cutaneous squamous cell carcino [...] imary cancer is not permitted) Has histologically confirmed locally advanced cutaneous squamous cell carcinoma (LA cSCC) with ≥1 high-risk feature(s) as the primary site of maligna [...] o the first dose of study intervention. Exclusion Criteria: Exclusion criteria include, but are not limited to: Has macroscopic residual cSCC after surgery and/or recurrenc [...]
Secondary endpointsdetails revised at 1 of 5 entries
2024-11-27
Study Status v180
Completion date2028-09-29→2025-12-22
2024-11-08
Study Status, References v179
Re-verified, no change to tracked fields
2024-09-18
Study Identification, Study Status, Study Design v178
Primary completion dateestimated 2025-05-05→confirmed 2024-06-28
Enrollment targetestimated 430→confirmed 450
2024-04-15
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v177
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 181 of 181 sites
2024-04-04
Study Status, Contacts/Locations v176
Study sites181 entries, revised
MonterNorthwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565)
2024-03-13
Study Status, Contacts/Locations v175
Study sitesdetails revised at 1 of 181 sites
2024-03-07
Study Status, Contacts/Locations v174
Study sitesdetails revised at 5 of 181 sites
2024-02-14
Study Status, Contacts/Locations v173
Study sitesdetails revised at 1 of 181 sites
2024-02-08
Study Status v172
Re-verified, no change to tracked fields
2024-01-19
Study Status, Contacts/Locations v171
Study sitesdetails revised at 3 of 181 sites
2023-12-28
Study Status, Contacts/Locations v170
Study sitesdetails revised at 1 of 181 sites
2023-12-21
Study Status, Contacts/Locations v169
Study sitesdetails revised at 1 of 181 sites
2023-12-15
Study Status, Contacts/Locations v168
Study sitesdetails revised at 3 of 181 sites
2023-12-07
Study Status, Contacts/Locations v167
Study sitesdetails revised at 2 of 181 sites
2023-12-01
Study Status, Contacts/Locations v166
Study sitesdetails revised at 2 of 181 sites
2023-11-23
Study Status, Contacts/Locations v165
Study sites181 entries, revised
CentroBradford de Investigación Oncológica delHill Norte ( Site 1652)
2023-11-16
Study Status, Study Design, Eligibility, Contacts/Locations v164
Enrollment target570→430
Eligibility criteria-2 characters
[...] rom randomization Is not pregnant or breastfeeding Is not a womanperson of childbearing potential (WOCBPPOCBP) Has a negative pregnancy test ≤72 hours before the first d [...] ligand 2 (PD-L2) agent or with an agent directed to another co-stimulatorycostimulatory or co-inhibitorycoinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated prot [...]
Study sites181 entries, revised
FundacionFundación Valle del Lili ( Site 0202)
2023-11-03
Study Status, Contacts/Locations v163
Study sites180→181
2023-10-18
Study Status, Contacts/Locations v162
Study sitesdetails revised at 1 of 180 sites
2023-10-11
Study Status, Contacts/Locations v161
Study sitesdetails revised at 3 of 180 sites
2023-10-06
Study Status, Contacts/Locations v160
Study sites179→180
2023-09-08
Study Status, Contacts/Locations v159
Study sitesdetails revised at 3 of 179 sites
2023-09-01
Study Status, Contacts/Locations v158
Study sitesdetails revised at 5 of 179 sites
2023-07-18
Study Status, Contacts/Locations v157
Study sites176→179
2023-07-07
Study Status, Contacts/Locations, References v156
Study sitesdetails revised at 4 of 176 sites
2023-06-28
Study Status, Contacts/Locations, References v155
Study sitesdetails revised at 4 of 176 sites
2023-06-23
Study Status, Contacts/Locations v154
Study sites175→176
2023-06-05
Study Status, Contacts/Locations v153
Study sitesdetails revised at 2 of 175 sites
2023-05-25
Study Status, Contacts/Locations v152
Study sites173→175
2023-05-18
Study Status, Contacts/Locations v151
Study sitesdetails revised at 3 of 173 sites
2023-05-11
Study Status, Contacts/Locations v150
Study sites173 entries, revised
Uniwersyteckie Centrum Kliniczne-KlinkaKlinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 0960)
2023-04-26
Study Status v149
Re-verified, no change to tracked fields
2023-04-12
Study Status, Contacts/Locations v148
Study sites173 entries, revised
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 151544)
2023-04-06
Study Status, Contacts/Locations v147
Study sitesdetails revised at 3 of 173 sites
2023-04-03
Study Status, Contacts/Locations v146
Study sitesdetails revised at 6 of 173 sites
2023-03-16
Study Status, Contacts/Locations v145
Study sitesdetails revised at 5 of 173 sites
2023-03-08
Study Status, Contacts/Locations v144
Study sitesdetails revised at 3 of 173 sites
2023-03-01
Study Status, Contacts/Locations v143
Study sitesdetails revised at 2 of 173 sites
2023-02-17
Study Status, Contacts/Locations v142
Study sitesdetails revised at 2 of 173 sites
2023-02-10
Study Status, Contacts/Locations v141
Study sites172→173
2023-02-03
Study Status, Contacts/Locations v140
Study sites171→172
2023-01-19
Study Status, Contacts/Locations v139
Study sites170→171
2023-01-12
Study Status, Contacts/Locations v138
Study sitesdetails revised at 1 of 170 sites
2023-01-05
Study Status, Contacts/Locations v137
Study sitesdetails revised at 1 of 170 sites
Merck (MSD)
401 trials monitored
See 24 trials at risk
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).
Trial Details
NCT Number NCT03833167
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Carcinoma, Squamous Cell
Enrollment 450 participants
Start Date 2019-04-01
Primary Completion 2024-06-28 (estimated)
Study Completion 2026-01-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-28