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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03833167

Studienbeginn:
April 2019

Letztes Update:
03.05.2021

Wirkstoff:
Pembrolizumab 400 mg, Placebo

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Merck Sharp & Dohme Corp.

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme Corp.

Kontakt

Studienlocations
(3 von 136)

Stanford University Medical Center ( Site 1503)
94305 Stanford
United StatesAbgeschlossen» Google-Maps
Winship Cancer Institute of Emory University ( Site 1512)
30322-1013 Atlanta
United StatesAbgeschlossen» Google-Maps
Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)
46202 Indianapolis
United StatesAbgeschlossen» Google-Maps
Massachusetts General Hospital ( Site 1518)
02114 Boston
United StatesAbgeschlossen» Google-Maps
Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)
C1181ACH Buenos Aires
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +541149590200
» Ansprechpartner anzeigen
Oncomedica S.A. ( Site 0205)
230002 Monteria
ColombiaAbgeschlossen» Google-Maps
Consultorios de Medicina Especializada del Sector Privado ( Site 0701)
44680 Guadalajara
MexicoAbgeschlossen» Google-Maps
Centro de atencion e investigacion clinica en oncologia ( Site 0706)
97134 Merida
MexicoAbgeschlossen» Google-Maps
Hifu Terramed Conformal SRL ( Site 1111)
031864 Bucharest
RomaniaAbgeschlossen» Google-Maps
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)
354057 Sochi
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +78622614079
» Ansprechpartner anzeigen
N.N. Blokhin NMRCO ( Site 1153)
115478 Moscow
Russian FederationAbgeschlossen» Google-Maps
FSCC FMBA of Russia ( Site 1163)
115682 Moscow
Russian FederationAbgeschlossen» Google-Maps
Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)
603126 Nizhny Novgorod
Russian FederationRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +79103989471
» Ansprechpartner anzeigen
Railway Hospital of OJSC ( Site 1161)
195271 Saint Petersburg
Russian FederationAbgeschlossen» Google-Maps
Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)
426067 Izhevsk
Russian FederationAbgeschlossen» Google-Maps
Hospital Universitario Marques de Valdecilla ( Site 1256)
39008 Santander
SpainAbgeschlossen» Google-Maps
Churchill Hospital ( Site 1404)
OX3 7LE Oxford
United KingdomAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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. For those participants with residual microscopic

positive margin involvement, confirmation that additional re-excision is not possible

must be provided

- Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and

≤16 weeks from randomization

- Has completed at least 45 Gray (Gy) 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 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

Studien-Rationale

Primary outcome:

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:

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 the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score (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. Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score (Time Frame - Baseline and up to approximately 60 months):
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.

4. 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.

5. 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.

Studien-Arme

  • 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.

Geprüfte Regime

  • Pembrolizumab 400 mg (KEYTRUDA® / MK-3475 / ):
    Administered by IV infusion on Day 1 of each 42-day cycle
  • Placebo:
    Administered by IV infusion on Day 1 of each 42-day cycle

Quelle: ClinicalTrials.gov


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