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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)

Status
Closed
Cancer Type
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03833167
Protocol IDs
3475-630 (primary)
KEYNOTE-630
2018-001974-76
NCI-2019-01629
MK-3475-630
Study Sponsor
Merck Sharp & Dohme LLC

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).

Eligibility

  1. 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)
  2. Has histologically confirmed LA cSCC with â?¥1 high-risk feature(s) as the primary site of malignancy
  3. 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
  4. Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT â?¥4 weeks and â?¤16 weeks from randomization
  5. Has received an adequate post-op dose of RT (either hypofractionated or conventional)
  6. Is disease free as assessed by the investigator with complete radiographic staging assessment â?¤28 days from randomization
  7. Is not pregnant or breastfeeding
  8. Is not a person of childbearing potential (POCBP)
  9. Has a negative pregnancy test â?¤72 hours before the first dose of study intervention.
  10. 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
  11. Has a life expectancy of >3 months
  12. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 â?¤10 days prior to the first dose of study intervention.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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