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Trial record 1 of 1 for:    NCT03833167
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Pembrolizumab Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

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ClinicalTrials.gov Identifier: NCT03833167
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a randomized, double-blind, study that compares pembrolizumab 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).

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Biological: Pembrolizumab 400 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 6, 2026
Estimated Study Completion Date : April 6, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: Pembrolizumab 400 mg
Administered by IV infusion on Day 1 of each 42-day cycle
Other Names:
  • KEYTRUDA®
  • MK-3475

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.
Drug: Placebo
Administered by IV infusion on Day 1 of each 42-day cycle




Primary Outcome Measures :
  1. Recurrence-free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy [ Time Frame: Up to approximately 60 months ]
    RFS was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 60 months ]
    OS is the time from randomization to death due to any cause.

  2. Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ)-C30 [ Time Frame: Baseline and up to approximately 60 months ]
    Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.

  3. Percentage of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 63 months ]
    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE will be presented.

  4. Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 38 months ]
    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE will be presented.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
  • Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
  • Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins
  • Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
  • Has completed at least 50 Gray (Gy) 25 fractions of adjuvant RT for LA cSCC prior to study entry
  • Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
  • Is not pregnant or breastfeeding
  • Is not a woman of childbearing potential (WOCBP)
  • Has a negative pregnancy test ≤72 hours before the first dose of study intervention
  • Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
  • Has a life expectancy of >3 months
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention

Exclusion Criteria:

  • Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
  • 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; Merkel cell carcinoma; or melanoma
  • Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti- PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
  • Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to randomization
  • Has not recovered from all radiation-related toxicities; has not required corticosteroids; and has not had radiation pneumonitis
  • Has received a live vaccine ≤30 days prior to the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device ≤4 weeks prior to the first dose of study intervention
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
  • Has had an allogeneic tissue/solid organ transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833167


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Florida
UF Health ( Site 1511) Recruiting
Gainesville, Florida, United States, 32610
Contact: Study Coordinator    352265068087617      
United States, New Jersey
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 1526) Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Study Coordinator    551-996-5900      
United States, Virginia
Inova Schar Cancer Institute ( Site 1538) Recruiting
Fairfax, Virginia, United States, 22031
Contact: Study Coordinator    703-970-6548      
France
Hopital ARCHET 2 ( Site 0356) Recruiting
Nice, France, 06200
Contact: Study Coordinator    +33492036223      
Centre Hospitalier Annecy Genevois ( Site 0361) Recruiting
Pringy, France, 74374
Contact: Study Coordinator    +33450636863      
Institut Claudius Regaud IUCT Oncopole ( Site 0354) Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33567778134      
Institut Gustave Roussy ( Site 0352) Recruiting
Villejuif, France, 94805
Contact: Study Coordinator    +33142114210      
Israel
Haddassah Medical Organization - Ein Kerem ( Site 0553) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    972508946244      
Rabin Medical Center ( Site 0550) Recruiting
Petah Tiqwa, Israel, 4941492
Contact: Study Coordinator    +97239378004      
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903752      
Norway
Haukeland sykehus ( Site 0851) Recruiting
Bergen, Norway, 5021
Contact: Study Coordinator    +4755974200      
Oslo Universitetssykehus Radiumhospitalet ( Site 0850) Recruiting
Oslo, Norway, 0379
Contact: Study Coordinator    +4722934000      
St. Olavs Hospital HF ( Site 0852) Recruiting
Trondheim, Norway, 7030
Contact: Study Coordinator    +4772825490      
Russian Federation
Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158) Recruiting
Izhevsk, Russian Federation, 426067
Contact: Study Coordinator    +79127614998      
FSCC FMBA of Russia ( Site 1163) Recruiting
Moscow, Russian Federation, 115682
Contact: Study Coordinator    +79265211330      
Railway Hospital of OJSC ( Site 1161) Recruiting
Saint Petersburg, Russian Federation, 195271
Contact: Study Coordinator    +79516760696      
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159) Recruiting
Sochi, Russian Federation, 354057
Contact: Study Coordinator    +78622614079      
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152) Recruiting
Yaroslavl, Russian Federation, 150054
Contact: Study Coordinator    +79036466903      
Spain
Hospital Duran i Reynals ( Site 1254) Recruiting
Hospitalet del Llobregat, Barcelona, Spain, 08908
Contact: Study Coordinator    +34932607333      
Hospital General Universitari Vall d Hebron ( Site 1252) Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +349327460004350      
Hospital Clinic i Provincial Barcelona ( Site 1253) Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932275402      
Hospital Universitario Ramon y Cajal ( Site 1251) Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Hospital Universitario Carlos Haya ( Site 1255) Recruiting
Malaga, Spain, 29010
Contact: Study Coordinator    +34951291165      
Hospital Universitario Marques de Valdecilla ( Site 1256) Recruiting
Santander, Spain, 39008
Contact: Study Coordinator    +34942202525      
United Kingdom
Churchill Hospital ( Site 1404) Completed
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03833167     History of Changes
Other Study ID Numbers: 3475-630
2018-001974-76 ( EudraCT Number )
MK-3475-630 ( Other Identifier: Merck Protocol Number )
KEYNOTE-630 ( Other Identifier: Merck )
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:
Programmed Cell Death-1 (PD-1)
Programmed Cell Death 1
PD1
Programmed Cell Death Ligand 1 (PD-L1)
Programmed Cell Death Ligand 2 (PD-L2)
PDL1
PDL2

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents