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RecruitingLast updated: 15 August 2023

KEYNOTE-630: This phase III trial is trying to determine whether an immunotherapy drug (Pembrolizumab) is an effective therapy to give after surgery and radiation in patients with locally advanced cutaneous squamous cell carcinomaA 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)

Clinical summary

Summary

Eligible participants will be randomised to receive 400mg of intravenous pembrolizumab or a placebo on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants, treated with either pembrolizumab or the placebo, who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.

Conditions

This trial is treating patients with cutaneous squamous cell carcinoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

III

Trial Acronym

KEYNOTE-630

More information

Trial Identifiers

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Commercial Sponsor

Merck

Scientific Title

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)

Eligibility

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.