KEYTRUDA® (pembrolizumab) in melanoma

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

KEYTRUDA as monotherapy is indicated for:

Adjuvant treatment of melanoma Advanced melanoma
For use in The adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection1 The treatment of advanced (unresectable or metastatic) melanoma in adults1
Dosing schedule The recommended dose is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes1
Duration of treatment Treat until disease recurrence, unacceptable toxicity, or for a duration up to one year1 Treat until disease progression or unacceptable toxicity1
Clinical trial KEYNOTE-054 was a randomised, double-blind Phase III study of adjuvant KEYTRUDA (pembrolizumab) vs placebo in patients with completely resected stage III melanoma.2 KEYNOTE-006 was a multicentre, randomised, controlled, three-arm, phase III study to evaluate the safety and the efficacy of KEYTRUDA vs ipilimumab in patients with advanced melanoma naïve to ipilimumab1,3

Click here to download:
KEYNOTE-054 clinical data presentation


Click here to download the KEYNOTE-006 clinical data presentation



  1. KEYTRUDA Summary of Product Characteristics
  2. Eggermont AMM, et al. N Engl J Med. 2018; 378: 1789–1801.
  3. Robert C, et al. N Engl J Med. 2015;372(26):2521-2532.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-OOC-00423 | Date of Preparation: April 2022