Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)
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ClinicalTrials.gov Identifier: NCT01848834 |
Recruitment Status :
Completed
First Posted : May 8, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 28, 2021
|
Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Cancer Solid Tumor |
Intervention |
Biological: Pembrolizumab |
Enrollment | 297 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | All allocated participants through end of trial (EOT) analysis cutoff date of 30 June 2020. |
Arm/Group Title | Cohort A: Triple Negative Breast Cancer | Cohort B: Head & Neck Cancer | Cohort C: Urothelial Cancer | Cohort D: Gastric Cancer | Cohort B2: Head & Neck Cancer Expansion |
---|---|---|---|---|---|
Arm/Group Description | Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. |
Period Title: Overall Study | |||||
Started | 32 | 61 | 33 | 39 | 132 |
Treated | 32 | 60 | 33 | 39 | 132 |
Completed | 13 [1] | 13 [1] | 9 [1] | 13 [1] | 38 [1] |
Not Completed | 19 | 48 | 24 | 26 | 94 |
Reason Not Completed | |||||
Adverse Event | 3 | 11 | 3 | 5 | 9 |
Death | 2 | 11 | 1 | 8 | 27 |
Excluded Medication | 5 | 4 | 3 | 6 | 6 |
Lost to Follow-up | 5 | 5 | 3 | 0 | 3 |
Physician Decision | 1 | 3 | 4 | 0 | 11 |
Protocol Violation | 0 | 0 | 0 | 0 | 1 |
Sponsor Decision | 1 | 1 | 0 | 1 | 1 |
Withdrawal by Subject | 2 | 13 | 10 | 6 | 36 |
[1]
Completed means two-year treatment completed
|
Baseline Characteristics
Arm/Group Title | Cohort A: Triple Negative Breast Cancer | Cohort B: Head & Neck Cancer | Cohort C: Urothelial Cancer | Cohort D: Gastric Cancer | Cohort B2: Head & Neck Cancer Expansion | Total | |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. | Total of all reporting groups | |
Overall Number of Baseline Participants | 32 | 61 | 33 | 39 | 132 | 297 | |
Baseline Analysis Population Description |
The baseline analysis population consisted of all allocated participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||||
Number Analyzed | 32 participants | 61 participants | 33 participants | 39 participants | 132 participants | 297 participants | |
51.9 (12.1) | 61.5 (11.5) | 68.5 (10.3) | 58.3 (13.2) | 58.9 (9.7) | 59.7 (11.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 32 participants | 61 participants | 33 participants | 39 participants | 132 participants | 297 participants | |
Female |
32 100.0%
|
12 19.7%
|
10 30.3%
|
11 28.2%
|
22 16.7%
|
87 29.3%
|
|
Male |
0 0.0%
|
49 80.3%
|
23 69.7%
|
28 71.8%
|
110 83.3%
|
210 70.7%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 32 participants | 61 participants | 33 participants | 39 participants | 132 participants | 297 participants | |
Hispanic or Latino |
2 6.3%
|
1 1.6%
|
1 3.0%
|
1 2.6%
|
7 5.3%
|
12 4.0%
|
|
Not Hispanic or Latino |
29 90.6%
|
58 95.1%
|
23 69.7%
|
37 94.9%
|
108 81.8%
|
255 85.9%
|
|
Unknown or Not Reported |
1 3.1%
|
2 3.3%
|
9 27.3%
|
1 2.6%
|
17 12.9%
|
30 10.1%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 32 participants | 61 participants | 33 participants | 39 participants | 132 participants | 297 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 2.6%
|
1 0.8%
|
2 0.7%
|
|
Asian |
0 0.0%
|
1 1.6%
|
0 0.0%
|
19 48.7%
|
28 21.2%
|
48 16.2%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
7 21.9%
|
6 9.8%
|
2 6.1%
|
0 0.0%
|
4 3.0%
|
19 6.4%
|
|
White |
25 78.1%
|
53 86.9%
|
31 93.9%
|
19 48.7%
|
95 72.0%
|
223 75.1%
|
|
More than one race |
0 0.0%
|
1 1.6%
|
0 0.0%
|
0 0.0%
|
1 0.8%
|
2 0.7%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 2.3%
|
3 1.0%
|
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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp. |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT01848834 |
Other Study ID Numbers: |
3475-012 2012-005771-14 ( EudraCT Number ) 142453 ( Registry Identifier: JAPIC_CTI ) MK-3475-012 ( Other Identifier: Merck ) |
First Submitted: | May 3, 2013 |
First Posted: | May 8, 2013 |
Results First Submitted: | April 7, 2017 |
Results First Posted: | June 26, 2017 |
Last Update Posted: | June 28, 2021 |