Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
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| ClinicalTrials.gov Identifier: NCT03553836 |
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Recruitment Status :
Active, not recruiting
First Posted : June 12, 2018
Results First Posted : June 24, 2022
Last Update Posted : February 9, 2024
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Melanoma |
| Interventions |
Biological: Pembrolizumab Other: Placebo |
| Enrollment | 976 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Per protocol, response/progression or adverse events (AEs) during re-challenge/switch-over in Part 2 were not counted towards the recurrence-free survival (RFS) outcome measure or safety outcome measures respectively. |
| Arm/Group Title | Pembrolizumab | Placebo |
|---|---|---|
 Arm/Group Description |
Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2. | Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2. |
| Period Title: Overall Study | ||
| Started | 487 | 489 |
| Treated | 483 | 486 |
| Re-challenged or Switched-over to Pembrolizumab | 1 | 45 |
| Completed | 0 | 0 |
| Not Completed | 487 | 489 |
| Reason Not Completed | ||
| Ongoing in Study | 460 | 459 |
| Withdrawal by Subject | 9 | 10 |
| Lost to Follow-up | 1 | 3 |
| Death | 17 | 17 |
Baseline Characteristics
| Arm/Group Title | Pembrolizumab | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2. | Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 487 | 489 | 976 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 487 participants | 489 participants | 976 participants | |
| 59.0 (12.6) | 59.6 (13.3) | 59.3 (12.9) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 487 participants | 489 participants | 976 participants | |
| Female |
187 38.4%
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200 40.9%
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387 39.7%
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| Male |
300 61.6%
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289 59.1%
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589 60.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 487 participants | 489 participants | 976 participants | |
| Hispanic or Latino |
49 10.1%
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30 6.1%
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79 8.1%
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| Not Hispanic or Latino |
390 80.1%
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409 83.6%
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799 81.9%
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| Unknown or Not Reported |
48 9.9%
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50 10.2%
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98 10.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 487 participants | 489 participants | 976 participants | |
| American Indian or Alaska Native |
1 0.2%
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0 0.0%
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1 0.1%
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| Asian |
4 0.8%
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1 0.2%
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5 0.5%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
4 0.8%
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4 0.8%
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8 0.8%
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| White |
435 89.3%
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439 89.8%
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874 89.5%
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| More than one race |
1 0.2%
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0 0.0%
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1 0.1%
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| Unknown or Not Reported |
42 8.6%
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45 9.2%
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87 8.9%
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Melanoma Primary Tumor (T) Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 487 participants | 489 participants | 976 participants |
| T3a |
2 0.4%
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0 0.0%
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2 0.2%
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| T3b |
200 41.1%
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201 41.1%
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401 41.1%
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| T4a |
113 23.2%
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116 23.7%
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229 23.5%
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| T4b |
172 35.3%
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172 35.2%
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344 35.2%
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[1]
Measure Description: Participants were stratified into T stages of melanoma, as defined by tumor thickness and ulceration, based on the American Joint Committee on Cancer (AJCC) 8th edition. The T stages were defined as follows: T3a: >2.0 - 4.0 mm thickness without ulceration; T3b: >2.0 - 4.0 mm thickness with ulceration; T4a: >4.0 mm without ulceration; T4b: >4.0 mm with ulceration.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
| Name/Title: | Senior Vice President, Global Clinical Development |
| Organization: | Merck Sharp & Dohme LLC. |
| Phone: | 1-800-672-6372 |
| EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT03553836 |
| Other Study ID Numbers: |
3475-716 MK-3475-716 ( Other Identifier: Merck ) KEYNOTE-716 ( Other Identifier: Merck ) 205203 ( Registry Identifier: JAPIC-CTI ) 2022-501966-23 ( Registry Identifier: EU CT Number ) U1111-1282-6109 ( Other Identifier: Universal Trial Number ) 2018-000669-35 ( EudraCT Number ) |
| First Submitted: | June 1, 2018 |
| First Posted: | June 12, 2018 |
| Results First Submitted: | May 26, 2022 |
| Results First Posted: | June 24, 2022 |
| Last Update Posted: | February 9, 2024 |