Trial Outcomes & Findings for A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers (NCT NCT02728830)

Last Updated: 2024-02-21

Results Overview

This outcome measures the change in tumor immune infiltrates post-pembrolizumab versus pre-pembrolizumab as measured by the PD-L1 Modified H-score. Histological score (H-score) is a score that is comprised of intensity and percentage of staining and is used for assessing amount of protein (in this case PD-L1) present in a tissue sample. H-score is determined by adding of the percentages of cell staining at each intensity level multiplied by the membrane intensity of staining (0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+(strong staining)). The H-score has a range of 0 to 300. Lower H-scores represent lower expression of PD-L1 in the tumor sample, while higher scores represent stronger expression of PD-L1 in the tumor samples.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

39 participants

Primary outcome timeframe

Baseline and 14-21 Days

Results posted on

2024-02-21

Participant Flow

Of the 39 subjects that were consented, 24 were screen failures. Nine were screen failures because exclusionary surgery, 6 because of exclusionary pathology, 3 because physician decision, 2 because of participant withdrawals, 1 was lost to follow up, 1 had exclusionary lab values, 1 had a contraindicated illness, and 1 had a language barrier.

Participant milestones

Participant milestones
Measure	Pembrolizumab Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Overall Study STARTED	39
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Overall Study Exclusionary Surgery	9
Overall Study Exclusionary Pathology	6
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1
Overall Study Exclusionary Lab Values	1
Overall Study Contraindicated Illness	1
Overall Study Language Barrier	1

Baseline Characteristics

A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=15 Participants Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants
Age, Continuous	63.7 years n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	15 Participants n=93 Participants
Primary Tumor Site Ovary	9 Participants n=93 Participants
Primary Tumor Site Fallopian Tube	3 Participants n=93 Participants
Primary Tumor Site Uterus	2 Participants n=93 Participants
Primary Tumor Site Other	1 Participants n=93 Participants
Histologic Subtype Adenocarcinoma; serous	12 Participants n=93 Participants
Histologic Subtype Adenocarcinoma; clear cell	3 Participants n=93 Participants
Tumor Grade at Diagnosis High Grade	10 Participants n=93 Participants
Tumor Grade at Diagnosis Low Grade	2 Participants n=93 Participants
Tumor Grade at Diagnosis Grade Cannot be Assessed	3 Participants n=93 Participants
FIGO Stage of Cancer at Diagnosis I	1 Participants n=93 Participants
FIGO Stage of Cancer at Diagnosis II	0 Participants n=93 Participants
FIGO Stage of Cancer at Diagnosis III	9 Participants n=93 Participants
FIGO Stage of Cancer at Diagnosis IV	1 Participants n=93 Participants
FIGO Stage of Cancer at Diagnosis Unstaged	4 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status 0	5 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status 1	10 Participants n=93 Participants
Debulking Surgery Optimal R0	7 Participants n=93 Participants
Debulking Surgery Optimal R1	5 Participants n=93 Participants
Debulking Surgery Suboptimal	2 Participants n=93 Participants
Debulking Surgery Not Applicable	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 14-21 Days

Population: Eleven subjects had adequate matched pre- and post- treatment tissue samples for analysis for tumor immune infiltrates.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=11 Participants Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Change in Tumor Immune Infiltrates as Measured by PD-L1 Modified H-Score	13.2 score on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: 18 months

Frequency and severity of adverse events associated with pembrolizumab when given to patients with newly diagnosed gynecologic cancers of müllerian origin prior to standard surgical therapy and as maintenance therapy after completion of chemotherapy. All events experienced within the AE reporting time frame deemed probably, possibly, or definitely related to study drug above the reporting threshold of 4%. Categorized by grade and frequency, defined using CTCAE 4.0 event name and grading.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=15 Participants Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Edema, Grade 1	3 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Anemia, Grade 1	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Neutropenia, Grade 2	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Thrombocytopenia, Grade 1	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Abdominal pain, Grade 1	5 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Abdominal pain, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE ALT elevation, Grade 1	8 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE ALT elevation, Grade 2	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE ALT elevation, Grade 3	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE AST elevation, Grade 1	7 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE AST elevation, Grade 2	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE AST elevation, Grade 3	3 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE ALK phosphatase elevation, Grade 1	7 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE ALK phosphatase elevation, Grade 2	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Arthralgia, Grade 1	3 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Anorexia, Grade 1	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Anorexia, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Back pain, Grade 1	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Bloating, Grade 1	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Bloating, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Constipation, Grade 1	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Constipation, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Diarrhea, Grade 1	6 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Diarrhea, Grade 2	9 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Diarrhea, Grade 3	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Dyspnea, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Fatigue, Grade 1	12 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Fatigue, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Headache, Grade 1	8 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hypertension, Grade 1	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hypertension, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hypertension, Grade 3	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hypoalbuminemia, Grade 1	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hypomagnesemia, Grade 1	3 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hypomagnesemia, Grade 2	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hyponatremia, Grade 1	3 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Hyponatremia, Grade 3	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Nausea, Grade 1	13 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Nausea, Grade 2	4 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Proteinuria, Grade 1	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Proteinuria, Grade 2	2 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Proteinuria, Grade 3	1 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Vomiting, Grade 1	13 Participants
Toxicity Profile: Frequency and Severity of Adverse Events as Assessed by CTCAE Weight loss, Grade 1	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 14-21 Days

Population: Thirteen participants had pre and post samples available for analysis

To characterize changes in the tumoral and circulating blood immunoprofile after administration of pembrolizumab. Levels of immune and inflammatory mediators, profile of tumor immune infiltrates, and the expression of PD-L1 in pre-administration samples will be compared to post-administration surgical resection (including ascites) samples.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=13 Participants Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile CXCL10 Fold Change, Pre to Post Pembro	1.5 fold change Interval 1.4 to 2.0
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile IFN-Gamma Fold Change, Pre to Post Pembro	1.6 fold change Interval 1.0 to 1.8
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile IL12p70 Fold Change, Pre to Post Pembro	1.1 fold change Interval 0.7 to 1.7
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile IL1b Fold Change, Pre to Post Pembro	1.9 fold change Interval 0.7 to 3.6
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile IL2ra Fold Change, Pre to Post Pembro	1.2 fold change Interval 1.0 to 1.4
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile IL6 Fold Change, Pre to Post Pembro	1.1 fold change Interval 0.9 to 1.3
Exploratory: Changes in Tumoral and Circulating Blood Immunoprofile TNF-Alpha Fold Change, Pre to Post Pembro	1.1 fold change Interval 1.0 to 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Population: No enrolled subjects qualified for the second course phase

To evaluate changes in the tumoral and circulating blood immunoprofile at time of recurrence. Levels of immune and inflammatory mediators, profile of tumor immune infiltrates, and the expression of PD-L1 in samples at time of recurrence will be compared to pre-administration and surgical samples.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab

Serious events: 3 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=15 participants at risk Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.7% 1/15 • Number of events 1 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Immune system disorders Allergic reaction	6.7% 1/15 • Number of events 1 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	6.7% 1/15 • Number of events 1 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.

Other adverse events

Other adverse events
Measure	Pembrolizumab n=15 participants at risk Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician. If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year. If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase. Pembrolizumab: Pembrolizumab 200mg IV
Blood and lymphatic system disorders Anemia	46.7% 7/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Investigations Neutrophil count decreased	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Investigations Platelet count decreased	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Investigations Alanine aminotransferase increased	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Investigations Alkaline phosphatase increased	33.3% 5/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Investigations INR increased	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Cardiac disorders Palpitations	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Cardiac disorders Pericardial effusion	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Endocrine disorders Hypothyroidism	26.7% 4/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Eye disorders Watering eyes	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Abdominal distension	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Abdominal pain	46.7% 7/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Ascites	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Bloating	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Constipation	46.7% 7/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Diarrhea	40.0% 6/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Dry mouth	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Gastroesophageal reflux disease	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Gastrointestinal disorders Nausea	40.0% 6/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
General disorders Fatigue	33.3% 5/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
General disorders Fever	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
General disorders General disorders and administration site conditions- Other, specify	26.7% 4/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
General disorders Non-cardiac chest pain	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
General disorders Pain	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Infections and infestations Papulopustular rash	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Infections and infestations Sinusitis	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Infections and infestations Upper respiratory infection	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Injury, poisoning and procedural complications Postoperative hemorrhage	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Metabolism and nutrition disorders Anorexia	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Metabolism and nutrition disorders Hyperglycemia	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Metabolism and nutrition disorders Hypoalbuminemia	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 5/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Metabolism and nutrition disorders Hyponatremia	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Musculoskeletal and connective tissue disorders Arthritis	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Musculoskeletal and connective tissue disorders Flank pain	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Concentration impairment	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Headache	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Memory impairment	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Paresthesia	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Peripheral sensory neuropathy	40.0% 6/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Presyncope	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Nervous system disorders Syncope	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Psychiatric disorders Depression	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Psychiatric disorders Insomnia	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Reproductive system and breast disorders Dyspareunia	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Reproductive system and breast disorders Dyspnea	26.7% 4/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders- other, specify	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Respiratory, thoracic and mediastinal disorders Wheezing	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Skin and subcutaneous tissue disorders Dry skin	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Skin and subcutaneous tissue disorders Pruritus	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 3/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders- other, specify	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Vascular disorders Hot flashes	13.3% 2/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Vascular disorders Hypertension	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.
Vascular disorders Thromboembolic event	6.7% 1/15 • The study collected AEs and SAEs from the time of informed consent to 30 days after the first Pembrolizumab infusion, an average of 1 month. AEs and SAEs were also collected during the Pembrolizumab maintenance phase. They were not collected while subjects were receiving standard of care chemotherapy.

Additional Information

Dr. Angeles Alvarez Secord

Duke Cancer Center

Phone: 919-684-3765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place