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).

Study on Skin Cancer Recurrence-Free Survival

Recruiting
18 years - 100 years
All
1 Location

Brief description of study.

The purpose of this study is to compare the recurrence-free survival (RFS), as assessed by the investigator and confirmed by biopsy, in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cutaneous squamous cell carcinoma
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following 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).
  • Is disease free as assessed by the investigator with complete radiographic staging assessment less than or equal to 28 days from randomization.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1903926878 (MK-3475-630)

This study investigates the recurrence-free survival in people with cutaneous squamous cell carcinoma (cSCC). Recurrence-free survival means the length of time after treatment during which the cancer does not return. The study compares those who receive an investigational medication with those who receive a placebo as additional therapy after primary treatment. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

Participants in the study will be randomly assigned to one of two study arms. One arm will receive the investigational medication, and the other will receive a placebo. The study will involve regular assessments by the investigator, including biopsy confirmation, to monitor the status of the cancer.

  • Who can participate: Adults with confirmed cutaneous squamous cell carcinoma, who are disease-free as assessed by the investigator, can participate. They must have completed radiographic staging assessment within 28 days before joining the study.
  • Study details: Participants will be assigned to receive either the investigational medication or a placebo. They will undergo regular assessments, including biopsy, to confirm the status of their cancer.

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