Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy (NCT NCT02411656)

NCT ID: NCT02411656

Last Updated: 2026-01-23

Results Overview

The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 71 participants
• Primary outcome timeframe: 4 months from the start of therapy
• Results posted on: 2026-01-23

Participant Flow

Participant milestones

Measure	Treatment (Pembrolizumab) Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
Overall Study STARTED	45
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Measure	Treatment (Pembrolizumab) Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
Overall Study Adverse Event	4
Overall Study Clinical Progression	33

Baseline Characteristics

Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy

Baseline characteristics by cohort

Measure	Treatment (Pembrolizumab) n=45 Participants Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
Age, Continuous	54 years n=270 Participants
Sex: Female, Male Female	45 Participants n=270 Participants
Sex: Female, Male Male	0 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=270 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=270 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=270 Participants
Race (NIH/OMB) Asian	2 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	0 Participants n=270 Participants
Race (NIH/OMB) White	38 Participants n=270 Participants
Race (NIH/OMB) More than one race	4 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Region of Enrollment United States	45 participants n=270 Participants

PRIMARY outcome

Timeframe: 4 months from the start of therapy

Population: Patients who received a total of at least 2 cycles of pembrolizumab were analyzed. Two patients were excluded because they discontinued the study treatment due to toxicity after one dose.

The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.

Outcome measures

Measure	Treatment (Pembrolizumab) n=43 Participants Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity	PD-L1 Positive Patients with PD-L1 CPS ≥10 based on IHC analysis
To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC	58.1 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first dose of pembrolizumab up to 5 years

Population: The patients with tumor samples available

PD-L1 satus in tumor tissue was determined by IHC analysis: positive CPS≥ 10, negative CPS <10. Median OS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).

Outcome measures

Measure	Treatment (Pembrolizumab) n=20 Participants Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity	PD-L1 Positive n=12 Participants Patients with PD-L1 CPS ≥10 based on IHC analysis
Correlation Between PD-L1 IHC Status and Overall Survival in Patients Treated With Pembrolizumab	26.0 months Interval 13.3 to 55.9	31.9 months Interval 9.2 to The upper bound of the 95% CI for the median overall survival (OS) was not estimable due to the high proportion of censored observations and insufficient number of events beyond the median, limiting the precision of upper-tail estimation.

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first dose of pembrolizumab up to 3 years

Population: The patients with tumor samples available

PD-L1 expression in tumor tissue was assessed by immunohistochemistry (IHC), with CPS ≥10 defined as PD-L1 positive and CPS <10 as PD-L1 negative.Median PFS and 95% confidence interval are estimated by the PD-L1 status in tumor tissue (positive vs. negative).

Outcome measures

Measure	Treatment (Pembrolizumab) n=20 Participants Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity	PD-L1 Positive n=12 Participants Patients with PD-L1 CPS ≥10 based on IHC analysis
Correlation Between PD-L1 IHC Status and Progression-Free Survival in Patients Treated With Pembrolizumab	3.9 months Interval 2.5 to 6.5	5.7 months Interval 3.4 to The upper bound of the 95% CI for the median overall survival (OS) was not estimable due to the high proportion of censored observations and insufficient number of events beyond the median, limiting the precision of upper-tail estimation.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: No data is available. As a result, no participants were included in this outcome measure analysis.

RNA-sequencing will be performed with RNA extracted from plasma at baseline.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From registration date to up to 5 years

Population: Patients who received a total of at least 2 cycles of pembrolizumab were analyzed.

Overall survival time from the registration date was estimated using Kaplan-Meier method.

Outcome measures

Measure	Treatment (Pembrolizumab) n=43 Participants Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity	PD-L1 Positive Patients with PD-L1 CPS ≥10 based on IHC analysis
Overall Survival for IBC or Non-IBC TNBC Patients Treated With Pembrolizumab	2.17 years Interval 1.11 to 3.19	—

Adverse Events

Treatment (Pembrolizumab)

Serious events: 13 serious events

Other events: 40 other events

Deaths: 34 deaths

Serious adverse events

Measure	Treatment (Pembrolizumab) n=45 participants at risk Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
Gastrointestinal disorders Abdominal pain	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Endocrine disorders Adrenal insufficiency	4.4% 2/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Colitis	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Constipation	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Dehydration	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Diarrhea	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Eye disorders Optic Neuritis	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Injury, poisoning and procedural complications Fracture	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Gait disturbance	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Headache	4.4% 2/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Hypercalcemia	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Endocrine disorders Hypothyroidism	4.4% 2/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Infections and infestations Infection	4.4% 2/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Infusion related reaction	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Nausea	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Infections and infestations Skin infection	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Vomiting	2.2% 1/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.

Other adverse events

Measure	Treatment (Pembrolizumab) n=45 participants at risk Pembrolizumab 200mg IV every 21 days for 8 cycles and then 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity
Gastrointestinal disorders Abdominal pain	13.3% 6/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Alanine aminotransferase increased	11.1% 5/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Alkaline phosphatase increased	13.3% 6/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Skin and subcutaneous tissue disorders Alopecia	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Blood and lymphatic system disorders Anemia	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Anorexia	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Psychiatric disorders Anxiety	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Musculoskeletal and connective tissue disorders Arthralgia	22.2% 10/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Aspartate aminotransferase increased	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Musculoskeletal and connective tissue disorders Back pain	11.1% 5/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Reproductive system and breast disorders Breast pain	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Injury, poisoning and procedural complications Bruising	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Cardiac disorders Heart Rate increased	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Musculoskeletal and connective tissue disorders Chest wall pain	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Chills	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Constipation	24.4% 11/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 15/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Creatinine increased	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Diarrhea	28.9% 13/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Dizziness	11.1% 5/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Eye disorders Dry eye	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Skin and subcutaneous tissue disorders Dry skin	11.1% 5/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Dysgeusia	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 10/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Edema limbs	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Endocrine disorders TSH decreased	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Injury, poisoning and procedural complications Fall	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Fatigue	40.0% 18/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Fever	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Flu like symptoms	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Gait disturbance	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Gastroesophageal reflux disease	11.1% 5/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Headache	42.2% 19/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Vascular disorders Hot flashes	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Hyperglycemia	13.3% 6/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Vascular disorders Hypertension	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Hypomagnesemia	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Hyponatremia	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Endocrine disorders Hypothyroidism	15.6% 7/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Infections and infestations Upper respiratory infection	13.3% 6/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Psychiatric disorders Insomnia	13.3% 6/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Lactate dehydrogenase (LDH) increased	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Vascular disorders Lymphedema	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Lymphocyte count decreased	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Memory impairment	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Metabolism and nutrition disorders Hyperphosphatemia	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Mucositis oral	11.1% 5/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Musculoskeletal and connective tissue disorders Muscle cramps	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Musculoskeletal and connective tissue disorders Myalgia	35.6% 16/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Respiratory, thoracic and mediastinal disorders Nasal congestion	26.7% 12/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Nausea	44.4% 20/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
General disorders Pain	24.4% 11/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Paresthesia	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Nervous system disorders Peripheral sensory neuropathy	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Skin and subcutaneous tissue disorders Pruritus	20.0% 9/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Skin and subcutaneous tissue disorders Rash acneiform	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 15/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Respiratory, thoracic and mediastinal disorders Sore throat	13.3% 6/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Stomach pain	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Gastrointestinal disorders Vomiting	33.3% 15/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations Weight loss	6.7% 3/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.
Investigations White blood cell decreased	8.9% 4/45 • All-Cause Mortality was assessed through study completion, up to 5 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 3 months after the last dose of drug, up to 3 years Adverse events were assessed according to the CTCAE version 4.0. All study patients who had received any dose of Pembrolizumab were evaluable for safety. Unexpected adverse events, including laboratory adverse events deemed clinically significant by the investigator, were graded and recorded.

Additional Information

Bora Lim, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 745-0689

Email: blim@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place