Adjuvant MK-3475 versus Placebo in Resected Highrisk Stage II Melanoma
Research type
Research Study
Full title
Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)
IRAS ID
249084
Contact name
Paul Lorigan
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-000669-35
Duration of Study in the UK
15 years, 0 months, 21 days
Research summary
The current standard of care for Stage II melanoma is surgical resection which leaves patients at risk of recurrence. Currently approved adjuvant therapies for Stage II melanoma, such as Interferon (IFN) alpha, have shown little or no improvement in regression-free survival, and show significant toxicities that can be fatal. Overall survival rates for patients with Stage II melanoma are similar to those with Stage III melanoma. All this suggests that the development of new adjuvant treatments for Stage II melanomas are greatly needed.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab, which has already been found to be effective against Stage III melanomas, has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This phase III study will last approximately 15 years (3 years treatment; 12 years follow-up) and will recruit approximately 954 participants, aged 12 years or over, with surgically resected high-risk Stage II
melanoma.The purpose of the study is to evaluate the effectiveness and safety of pembrolizumab given as an adjuvant therapy, versus placebo therapy. Participants will be assigned randomly in a 1:1 ratio to one of the two groups of the trial for Part 1 of the trial. Eligible participants from both groups who complete Part 1 may then enter Part 2 to receive further pembrolizumab treatment.
The study is sponsored by Merck Sharp & Dohme Limited. It will take place at four study centres in UK.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0401
Date of REC Opinion
6 Sep 2018
REC opinion
Further Information Favourable Opinion