Trial Outcomes & Findings for Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer (NCT NCT03072160)

Last Updated: 2021-02-11

Results Overview

Participants with medullary thyroid cancer were administered a programmed cell death protein 1 (PD1) inhibitor to determine if any experienced a 50% or greater decline in calcitonin levels. A calcitonin response is defined as participants with a ≥50% decline from baseline that is then confirmed on a subsequent calcitonin assessment at least one week later.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

2 years

Results posted on

2021-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Cancer Vaccine Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Overall Study STARTED	13	4
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Cancer Vaccine Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Overall Study Adverse Event	3	1
Overall Study Refused further treatment	6	1
Overall Study Physician Decision	1	0
Overall Study Disease progression on study	1	1
Overall Study No contact	0	1

Baseline Characteristics

Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants	2 Participants n=4 Participants	12 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Age, Continuous	52.82 years STANDARD_DEVIATION 11.8 • n=93 Participants	59.48 years STANDARD_DEVIATION 11.85 • n=4 Participants	56.15 years STANDARD_DEVIATION 11.82 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	3 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	3 Participants n=4 Participants	14 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	4 participants n=4 Participants	17 participants n=27 Participants
Median Baseline Carcinoembryonic Antigen (CEA)	125 ng/ml n=93 Participants	207 ng/ml n=4 Participants	175 ng/ml n=27 Participants
Median Baseline Calcitonin	509 pg/ml n=93 Participants	6000 pg/ml n=4 Participants	6000 pg/ml n=27 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Clinical Response	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 years

Participants were imaged by CT or MRI and followed for response using the Immune-Related Response Criteria (irRC). Partial Response is a ≥30% decrease in the sum of the largest diameter (SLD) compared with baseline confirmed by a consecutive assessment at least 4 weeks after the first documentation. Complete Response is a 100% disappearance of all lesions, whether measurable or not, and no new lesions, in two consecutive observations not less than 4 weeks from the date first documented.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Percentage of Participants With a Partial Response and Complete Response by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 and 84 days

Regulatory T-Cells (CD4, CD8, Tregs, and NK cells) in peripheral blood mononuclear cell (PBMC)s were measured by 7-color flow cytometry.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=16 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=16 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants CD4	34.73 Percentage change Interval 12.5 to 53.5	33.95 Percentage change Interval 9.7 to 46.5	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants CD8	13.70 Percentage change Interval 6.17 to 26.3	12.50 Percentage change Interval 6.5 to 24.22	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants Tregs	0.70 Percentage change Interval 0.0 to 1.2	0.77 Percentage change Interval 0.46 to 1.8	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants NK	10.47 Percentage change Interval 6.6 to 17.7	10.26 Percentage change Interval 4.6 to 19.5	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: every 3 weeks while on treatment and post treatment, up to 2 years

A sustained 50% decline in CEA. A large magnitude decline in CEA may be associated with tumor responses.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Number of Participants With a Sustained Decline in Carcinoembryonic Antigen (CEA)	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: every 3 weeks while on treatment and post treatment, up to 2 years

A sustained 50% decline in calcitonin. A large magnitude decline in calcitonin may be associated with tumor responses.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Number of Participants With a Sustained Decline in Calcitonin	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 weeks for up to 2 years while on treatment than 2 weeks after last treatment

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression, assessed by the Immune-Related Response Criteria (irRC), is defined as at least 20% increase in the sum of the largest diameter (SLD) compared with nadir (minimum recorded tumor burden) and an increase of at least 5mm over the nadir, confirmed by a repeat,consecutive observations at least 4 weeks from the date first documented.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=1 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=1 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Progression-free Survival (PFS)	210 Days	55 Days	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

Percentage of participants who are alive at 2 years.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Overall Survival at 2 Years	100 percentage of participants	50 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life-threatening; urgent intervention indicated. Grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related n=13 Participants Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related n=13 Participants Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related n=13 Participants Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related n=13 Participants Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related n=13 Participants Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related n=13 Participants Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related n=13 Participants Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related n=4 Participants Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related n=4 Participants Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related n=4 Participants Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related n=4 Participants Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related n=4 Participants Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related n=4 Participants Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related n=4 Participants Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related n=4 Participants Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related n=4 Participants Adverse events definitely related to Pembrolizumab.
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Diarrhea	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Renal and urinary disorders	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Anemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Acute kidney injury	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Alanine aminotransferase	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Allergic rhinitis	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Anorexia	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Arthralgia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Aspartate aminotransferase	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Dizziness	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Dry eye	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Dry skin	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Eye disorders	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Eye pain	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Fatigue	6 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Flashing lights	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Flu-like symptoms	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Generalized muscle weakness	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Headache	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Hearing impaired	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Injection site reaction	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Nausea	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Neutrophil count decreased	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Pain in extremity	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Pain of skin	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Platelet count decreased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Pruritis	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Rash acneiform	4 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Rash maculopapular	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab Skin and subcutaneous tissue disorders	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab White blood cell decreased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related n=13 Participants Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related n=13 Participants Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related n=13 Participants Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related n=13 Participants Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related n=4 Participants Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related n=4 Participants Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related n=4 Participants Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related n=4 Participants Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related n=4 Participants Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related n=4 Participants Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Dry mouth	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Edema limbs	0 Participants	2 Participants	00 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypokalemia	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Peripheral motor neuropathy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Paresthesia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Fatigue	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Lymphocyte count decreased	0 Participants	4 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypernatremia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Allergic rhinitis	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hyperuricemia	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Flank pain	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Abdominal pain	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Alanine aminotransferase increased	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Anemia	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Anorexia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Aspartate aminotransferase increased	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Back pain	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Blood bilirubin increased	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Buttock pain	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Cataract	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Cough	0 Participants	4 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab CPK increased	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Dehydration	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Diarrhea	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Dizziness	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Dry skin	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Dyspnea	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Ear and labyrinth disorders	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Edema face	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Enterocolitis	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Eye disorders	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Eye pain	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Flushing	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	00 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Gait disturbance	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab General disorders & admin. site conditions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Generalized muscle weakness	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Headache	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hyperglycemia	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypoalbuminemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypocalcemia	0 Participants	8 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hyponatremia	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Insomnia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Lip pain	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Menopause	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Nail ridging	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Nasal congestion	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Nausea	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Neck pain	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Pain	0 Participants	6 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Pain in extremity	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab White blood cell decreased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Creatinine increased	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Upper respiratory infection	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Respiratory, thoracic and mediastinal disorders	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypotension	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Presyncope	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Wheezing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypercalcemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Skin infection	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Rhinitis infective	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Rash acneiform	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypomagnesemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab Hypoglycemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Cohort 1: Cancer Vaccine n=13 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: cancer vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 1: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 1: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 1: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 1: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 1 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 1 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 1 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 2 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 2 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 2 Definitely Related Adverse events definitely related to Pembrolizumab.	Cohort 2: Grade 3 Possibly Related Adverse events possibly related to Pembrolizumab.	Cohort 2: Grade 3 Probably Related Adverse events probably related to Pembrolizumab.	Cohort 2: Grade 3 Definitely Related Adverse events definitely related to Pembrolizumab.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	13 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Cohort 1: Cancer Vaccine

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Cohort 2: Participants That Have Had No Vaccine

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Cancer Vaccine n=13 participants at risk Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 1: had an immune stimulating cancer vaccine previously Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.	Cohort 2: Participants That Have Had No Vaccine n=4 participants at risk Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years. Group 2: had no previous vaccine Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
Renal and urinary disorders Renal and urinary disorders - Other, Acute interstitial nephritis	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
Infections and infestations Upper respiratory infection	7.7% 1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
Ear and labyrinth disorders Hearing impaired	0.00% 0/13 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.

Other adverse events

Additional Information

Dr. Ravi Madan

National Cancer Institute

Phone: 301-480-7168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place