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

  • STATUS
    Recruiting
  • End date
    Sep 29, 2028
  • participants needed
    570
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 26 September 2021
cancer
pembrolizumab
adjuvant therapy
mk-3475

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).

Details
Condition Squamous cell carcinoma
Treatment Placebo, Pembrolizumab 400 mg
Clinical Study IdentifierNCT03833167
SponsorMerck Sharp & Dohme Corp.
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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 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), antiPD -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 (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
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