Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide (NCT NCT02312557)

Last Updated: 2026-05-14

Results Overview

One-sample binomial test will be used to assess whether the proportion of PSA response (PSA decrease of at least 50%) is significantly greater than 0.05. Univariable logistic regression analysis will be conducted to assess the association between immunological parameters and PSA response responses. Scale in logit will be assessed for all continuous parameters that are identified to be significantly associated with PSA response. Descriptive statistical analysis will be conducted. The proportion estimate will be reported with 95% confidence interval.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Up to 30 days after completion of study treatment, up to approximately 2.5 years total.

Results posted on

2026-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Pembrolizumab) INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Study STARTED	58
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Pembrolizumab) INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Study Survival follow-up	4

Baseline Characteristics

Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pembrolizumab) n=58 Participants INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=1512 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=1512 Participants
Age, Categorical >=65 years	46 Participants n=1512 Participants
Sex: Female, Male Female	0 Participants n=1512 Participants
Sex: Female, Male Male	58 Participants n=1512 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=1512 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=1512 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=1512 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1512 Participants
Race (NIH/OMB) Asian	1 Participants n=1512 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1512 Participants
Race (NIH/OMB) White	50 Participants n=1512 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=1512 Participants
Region of Enrollment United States	57 participants n=1512 Participants
Region of Enrollment Canada	1 participants n=1512 Participants

PRIMARY outcome

Timeframe: Up to 30 days after completion of study treatment, up to approximately 2.5 years total.

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab) n=58 Participants INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
PSA Response, Defined by a PSA Decrease of at Least 50% Confirmed by a Second Measurement at Least 3 Weeks Later	11 Participants

SECONDARY outcome

Timeframe: Baseline to up to 4 weeks

Descriptive statistical analysis will be conducted. The proportion estimate will be reported with 95% confidence interval, and the continuous variables will be summarized using nmissing, mean, std, median, min, and max.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

Descriptive statistical analysis will be conducted. The proportion estimate will be reported with 95% confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab) n=58 Participants INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Survival	17.6 months Interval 14.7 to 23.0

SECONDARY outcome

Timeframe: Baseline to up to 30 days after completion of study treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

If there is a decline from baseline, progression is an increase in PSA that is 25% and 2 ng/ml above the nadir, which is confirmed by a second value 3 or more weeks later (i.e., a confirmed rising trend). Kaplan-Meier curve will be plotted to illustrate the PSA progression free survival for all, and for subgroups (abiraterone versus no prior abiraterone and sipuleucel-T versus no prior sipuleucel-T).

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab) n=58 Participants INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
PSA Progression Free Survival, Where the Definition of Progression Will be PSA Progression Per Prostate Cancer Working Group 2 Criteria	4.3 months Interval 3.4 to 7.6

SECONDARY outcome

Timeframe: Up to 4 weeks

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Pembrolizumab)

Serious events: 27 serious events

Other events: 55 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Pembrolizumab) n=58 participants at risk INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Nervous system disorders Myelitis	8.6% 5/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Reproductive system and breast disorders Pelvic pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Hypercalcemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Blood and lymphatic system disorders Anemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Constipation	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Back pain	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Endocrine disorders Diabetes mellitus I	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Urinary tract infection	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Hematuria	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cancer	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Enterocolitis infectious	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Injury, poisoning and procedural complications Fracture	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Fall	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Colitis	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Urinary tract obstruction	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Cardiac disorders Mobitz (type) II atrioventricular block	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Sepsis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Aspartate aminotransferase increased	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Anemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Hypercalcemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Dehydration	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Fatigue	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Nausea	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Anorexia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Hemorrhoids	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.

Other adverse events

Other adverse events
Measure	Treatment (Pembrolizumab) n=58 participants at risk INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
General disorders Fatigue	22.4% 13/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Diarrhea	13.8% 8/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Nausea	19.0% 11/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Cardiac disorders Palpitations	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Back pain	15.5% 9/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Abdominal pain	8.6% 5/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Vascular disorders Hypertension	44.8% 26/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Gastroesophageal reflux disease	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Endocrine disorders Hypothyroidism	10.3% 6/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Blood and lymphatic system disorders Anemia	10.3% 6/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.7% 12/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Anorexia	22.4% 13/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Urinary incontinence	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Fecal incontinence	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Flu like symptoms	6.9% 4/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Constipation	19.0% 11/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Urinary tract obstruction	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Hematuria	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Bladder spasm	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Muscle spasm	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Proteinuria	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Facial muscle weakness	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Injury, poisoning and procedural complications Fall	12.1% 7/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Weight loss	8.6% 5/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Dizziness	10.3% 6/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Dry mouth	8.6% 5/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 7/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	6.9% 4/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Mass on arm	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Hypoglycemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Dehydration	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Myelitis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Eyelid function disorder	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	19.0% 11/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Upper respiratory infection	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	12.1% 7/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Skin infection	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Colitis	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Amnesia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Urinary urgency	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Fungal infection	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Dry skin	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Urinary tract infection	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Psychiatric disorders Confusion	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Facial nerve disorder	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Neuralgia	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Watering eyes	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Rectal Hemorrhage	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Aspartate aminotransferase increased	8.6% 5/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Alanine amonitransferase increased	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Injury, poisoning and procedural complications Bruising	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Bone pain	10.3% 6/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Endocrine disorders Endocrine disorders other, sweats	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Edema limbs	5.2% 3/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Floaters	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Hypercalcemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Platelet count decreased	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Reproductive system and breast disorders Pelvic pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Diabetes mellitus 1	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperglycemia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Neck pain	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Penile infection	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Conjunctivitis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Headache	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Radiculitis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Wheezing	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Cataract	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Pruritus	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Stye	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Peripheral sensory neuropathy	6.9% 4/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Non-cardiac chest pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Mucositis oral	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - red patch left cheek	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	10.3% 6/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Hemorrhoidal hemorrhage	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Psychiatric disorders Insomnia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - cut, right forearm	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Memory impairment	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Cardiac disorders Atrial fibrillation	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Ear and labyrinth disorders Vertigo	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Ear and labyrinth disorders Hearing impaired	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Vascular disorders Hot flashes	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Cheilitis	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Pain, shoulder	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Injury, poisoning and procedural complications Dermatitis radiation	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Cardiac disorders Tachycardia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Tremor	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Endocrine disorders Hyperthyroidism	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Dysesthesia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Chills	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Reproductive system and breast disorders Testicular pain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations Weight gain	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Nervous system disorders Dysgeusia	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Skin induration	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Bloating	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Rash acneiform	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
General disorders Localized edema	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Reproductive system and breast disorders Genital edema	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Gastrointestinal disorders Dysphagia	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Myositis	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Injury, poisoning and procedural complications Spinal fracture	3.4% 2/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Renal calculi	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Tooth infection	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Infections and infestations Bronchial infection	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Cardiac disorders Acute coronary syndrome	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Renal and urinary disorders Urinary retention	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Injury, poisoning and procedural complications Fracture	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Eye disorders Glaucoma	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Metabolism and nutrition disorders Hypernatremia	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.
Investigations CPK increased	1.7% 1/58 • After the end of treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment. If the investigator learns of any AEs or SAEs related to pembrolizumab beyond the 90 days but less than 2.5 years, then that will be captured. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs. Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE Version 4.0.

Additional Information

Rachel Slottke

Oregon Health & Science University

Phone: 503-494-6117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place