Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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).
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Head and Neck Cancer
Enrollment Eligibility
Inclusion Criteria:
- Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary
site of malignancy (metastatic skin involvement from another type of 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 received an adequate post-op dose of RT (either hypofractionated or conventional)
- 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 before start of study intervention.
- 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
- Has received an investigational agent or has used an investigational device within 4
weeks prior to the first dose of study treatment.
- Has known additional malignancy that is progressing or has required active treatment
within the past 2 years. Note: Participants with basal cell carcinoma of the skin,
squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ
of the bladder, that have undergone potentially curative therapy are not excluded.
Other exceptions may be considered with Sponsor consultation. Note: Participants with
low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or
T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng/ml) either treated
with definitive intent or untreated in active surveillance that has been stable for
the past year prior to study allocation. Early stage asymptomatic CLL without prior
treatment and without any of the risk features (unmutated IGHV, lymphocytes >15,000μL,
palpable lymph nodes) will be eligible for the study
- Has an active autoimmune disease that has required systemic treatment in past 2 years
except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- 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