Keynote-716 : Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

12+Age Over 12

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase III trial is evaluating the safety and effectiveness of the immunotherapy drug, Pembrolizumab, in patients with surgically removed high-risk stage II melanoma.
 

This trial is treating patients with melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • 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.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study

Commercial Sponsor

Merck

Summary

This is a 2-part clinical trial, in which patients will be randomised to receive permbrolizumab or placebo for up to 17 cycles. In the experimental arm (Part 1), paediatric patients will receive up to 17 cycles of 2 mg/kg (200 mg maximum) pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) and adult patients will receive up to 17 cycles of 200 mg pembrolizumab by IV infusion Q3W. Patients who complete the full 17 cycles of pembrolizumab and experience disease recurrence may be eligible to receive additional treatment with pembrolizumab in an open label design (Part 2). In Part 2, patients will receive either 17 cycles of pembrolizumab for local/distant recurrence following resection of disease or up to 35 cycles of pembrolizumab for disease that cannot be resected or metastatic disease. Patients in the placebo arm (Part 1) will receive 17 cycles of saline placebo by IV infusion Q3W in a double-blind design. Patients that complete 17 cycles of placebo and experience disease recurrence may be eligible to receive pembrolizumab in Part 2 of the study, as described above.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Victorian Melanoma Service
Prahran
Ms Merran Tyler
m.tyler@alfred.org.au
03 9076 2297

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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