Trial Outcomes & Findings for Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma (NCT NCT02296684)

Last Updated: 2026-01-15

Results Overview

* Major pathologic treatment effect=pathologic tumor response (pTR). * pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (\>10%), pTR-1 (10-49%), and pTR-2 (≥50%).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

Results posted on

2026-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery).	Not Assigned to an Arm (Cohort) -Participants who did not receive any treatment and were not assigned to an arm (cohort).
Overall Study STARTED	36	30	1
Overall Study COMPLETED	34	29	0
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery).	Not Assigned to an Arm (Cohort) -Participants who did not receive any treatment and were not assigned to an arm (cohort).
Overall Study Withdrawal by Subject	0	1	1
Overall Study Death	2	0	0

Baseline Characteristics

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=36 Participants * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=30 Participants -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery).	Not Assigned to an Arm (Cohort) n=1 Participants -Participants who did not receive any treatment and were not assigned to an arm (cohort).	Total n=67 Participants Total of all reporting groups
Age, Continuous	59.5 years n=14 Participants	62.5 years n=10 Participants	51 years n=24 Participants	61 years n=78 Participants
Sex: Female, Male Female	10 Participants n=14 Participants	10 Participants n=10 Participants	0 Participants n=24 Participants	20 Participants n=78 Participants
Sex: Female, Male Male	26 Participants n=14 Participants	20 Participants n=10 Participants	1 Participants n=24 Participants	47 Participants n=78 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	1 Participants n=78 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=14 Participants	29 Participants n=10 Participants	1 Participants n=24 Participants	64 Participants n=78 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants	1 Participants n=10 Participants	0 Participants n=24 Participants	2 Participants n=78 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants	2 Participants n=78 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Black or African American	6 Participants n=14 Participants	2 Participants n=10 Participants	0 Participants n=24 Participants	8 Participants n=78 Participants
Race (NIH/OMB) White	29 Participants n=14 Participants	28 Participants n=10 Participants	0 Participants n=24 Participants	57 Participants n=78 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants
Region of Enrollment United States	36 participants n=14 Participants	30 participants n=10 Participants	1 participants n=24 Participants	67 participants n=78 Participants

PRIMARY outcome

Timeframe: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

Population: Evaluable Cohort 1 participants for this outcome measure were those who had a high-risk pathology in the surgical specimen after one dose of neoadjuvant MK-3475 (pembrolizumab).

-The percentage of participants who developed local-regional recurrence within one year of surgery

Outcome measures

Outcome measures
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=18 Participants * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=30 Participants -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Locoregional Recurrence Rates in Cohorts 1 and 2	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

Population: -Evaluable Cohort 1 participants for this outcome measure were those who had a high-risk pathology in the surgical specimen after one dose of neoadjuvant MK-3475 (pembrolizumab).

-The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed.

Outcome measures

Outcome measures
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=18 Participants * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=30 Participants -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Distant Failure Rate in Cohorts 1 and 2	3 Participants	1 Participants

PRIMARY outcome

Timeframe: At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)

Population: Only those participants enrolled in Cohort 1 were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=36 Participants * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Rate of Major Pathologic Treatment Effect in Cohort 1 pTR-0	20 Participants	—
Rate of Major Pathologic Treatment Effect in Cohort 1 pTR-1	8 Participants	—
Rate of Major Pathologic Treatment Effect in Cohort 1 pTR-2	8 Participants	—

PRIMARY outcome

Timeframe: At the time of surgery (surgery occurred within 13-22 days after last neoadjuvant MK-3475 dose)

Population: Only those participants enrolled in Cohort 2 were evaluable for this outcome measure. One participant in Cohort 2 not evaluable for this outcome measure because the participant did not have surgery. One participant in Cohort 2 not evaluable because the data was missing.

Outcome measures

Outcome measures
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=28 Participants -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Rate of Major Pathologic Treatment Effect in Cohort 2 pTR-0	—	13 Participants
Rate of Major Pathologic Treatment Effect in Cohort 2 pTR-1	—	2 Participants
Rate of Major Pathologic Treatment Effect in Cohort 2 pTR-2	—	13 Participants

SECONDARY outcome

Timeframe: Through 30 days after last dose of MK-3475

Population: Only 12 participants in Cohort 1 received adjuvant MK-3475.

Reportable adverse events will be tracked for 30 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events thought to be possibly, probably, or definitely related to MK-3475. Events thought to be probably or definitely related to surgery, adjuvant chemotherapy, or radiotherapy need not be recorded.

Outcome measures

Outcome measures
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=36 Participants * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=30 Participants -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 fatigue (neoadjuvant period)	2 Participants	3 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 fever (neoadjuvant period)	1 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 tumor flare (neoadjuvant period)	1 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 AST increase (neoadjuvant period)	0 Participants	2 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 ALT increase (neoadjuvant period)	0 Participants	2 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 fatigue (adjuvant period)	2 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 hypothyroidism (adjuvant period)	3 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 3-4 hypothyroidism (adjuvant period)	1 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 AST increase (adjuvant period)	1 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 ALT increase (adjuvant period)	1 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 alkaline phosphatase increase (adjuvant period)	1 Participants	0 Participants
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events Grades 1-2 diarrhea (adjuvant period)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At the time of surgery (approximately 2-3 weeks after registration)

Population: One participant in Cohort 2 is not evaluable for the outcome measure because the participant did not have surgery.

Outcome measures

Outcome measures
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=36 Participants * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=29 Participants -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Number of Surgical Complications and/or Delays in Cohorts 1 and 2	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Through completion of follow-up (estimated to be 5 years after treatment)

Outcome measures

Outcome data not reported

Serious events: 1 serious events

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 n=36 participants at risk * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.	Cohort 2: Neoadjuvant MK-3475 n=30 participants at risk -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery).
Cardiac disorders Atrial fibrillation	2.8% 1/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Immune system disorders Immune-related hepatitis	0.00% 0/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	3.3% 1/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Infections and infestations Catheter related infection	2.8% 1/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Infections and infestations Pneumonitis	0.00% 0/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	3.3% 1/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Infections and infestations Sepsis	5.6% 2/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Infections and infestations Upper respiratory infection	0.00% 0/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	3.3% 1/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Injury, poisoning and procedural complications Tracheal obstruction	2.8% 1/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Injury, poisoning and procedural complications Wound dehiscence	2.8% 1/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Investigations Alanine aminotransferase increased	0.00% 0/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	3.3% 1/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Investigations Aspartate aminotransferase increased	0.00% 0/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	3.3% 1/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.8% 1/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
Vascular disorders Thromboembolic event	5.6% 2/36 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.	0.00% 0/30 • For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery). The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.

Other adverse events

Additional Information

Douglas R. Adkins, M.D.

Washington University School of Medicine

Phone: 314-362-4471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place