Immunotherapy after surgery may keep melanoma at bay
NCT ID NCT02362594
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving the immunotherapy drug pembrolizumab after surgery helps prevent melanoma from returning in people with high-risk stage III melanoma. About 1,000 participants received either pembrolizumab or a placebo for up to a year. The main goal was to see if the drug delays recurrence or death. Those whose cancer returned could receive pembrolizumab later.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,019 people
The number who actually took part.
- Started
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Jul 2015
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Completely resected Stage III melanoma * Tumor tissue available for evaluation of PD-L1 expression * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function * No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible) * Female participants of childbearing potential should be willing to use adequate methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication * Male participants should agree to use an adequate method of birth control starting with the first dose of study therapy through 120 days after the last dose of study medication Exclusion criteria: * Mucosal or ocular melanoma * History of (non-infectious) pneumonitis that required steroids or current pneumonitis * History of or current interstitial lung disease * History of hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years * Active autoimmune disease that has required systemic treatment in past 2 years * Active infection requiring therapy * Unstable hyperthyroidism or hypothyroidism * Diagnosis of immunodeficiency * Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Known history of human immunodeficiency virus (HIV), active Hepatitis B or C * Treatment with live vaccine within 30 days prior to the first dose of study medication are not eligible * Prior treatment with any anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) monoclonal antibody or anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent, or prior participation in any Merck pembrolizumab clinical trial * Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study medication * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study medication * Participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial without prospective Institutional Review Board approval (by chair or designee) is given
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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