Loading
A phase 3 trial of Pembrolizumab in melanoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.
Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) is a phase 3 interventional study registered as NCT02362594 by Merck Sharp & Dohme LLC, with 1019 participants enrolled, started 2015-07-16 and due to reach its primary completion in 2018-01-08. Interventions recorded: pembrolizumab, placebo. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2019; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,019 enrolled.
95% CI 78.6 to 85.3; Figures from the ClinicalTrials.gov results section (first posted 2019-01-04), not from a publication · 95% CI 69.2 to 77.0
Source95% CI 80.0 to 87.0; Figures from the ClinicalTrials.gov results section (first posted 2019-01-04), not from a publication · 95% CI 71.0 to 79.2
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participantsprimary | Pembrolizumab | 514 | 82.2% | 0.57 | <0.0001 | link |
| Placebo | 505 | 73.3% | ||||
| Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expressionprimary | Pembrolizumab | 428 | 83.8% | 0.54 | <0.0001 | link |
| Placebo | 425 | 75.4% |
A second publication from the KEYNOTE-054 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Adjuvant pembrolizumab is a standard for resected stage III melanoma, with subsequent trials extending it to stage II and to the neoadjuvant setting.
Shares Stage III melanoma (after surgery), Melanoma, Pembrolizumab, Immune checkpoint inhibitors.
Shares Stage III melanoma (after surgery), Melanoma, Pembrolizumab, Immune checkpoint inhibitors.
Shares Stage III melanoma (after surgery), Melanoma, Pembrolizumab, Immune checkpoint inhibitors.
Shares Stage III melanoma (after surgery), Melanoma, Pembrolizumab.
Shares Stage III melanoma (after surgery), Melanoma, Pembrolizumab, Immune checkpoint inhibitors.
Shares Stage III melanoma (after surgery), Melanoma, Pembrolizumab, Immune checkpoint inhibitors.
Shares Stage III melanoma (after surgery), Melanoma, Immune checkpoint inhibitors.