Trial Outcomes & Findings for Pembrolizumab in Metastatic Anal Cancer (NCT NCT02919969)
NCT ID: NCT02919969
Last Updated: 2023-06-12
Results Overview
Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. A complete response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Disease was evaluated radiologically at baseline and every 3 cycles on treatment. The median follow-up was 12.6 months. All registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)
Results posted on
2023-06-12
Participant Flow
38 patients were consented and screened for the trial
32 patients met eligibility criteria and were treated with the study drug
Participant milestones
| Measure |
Pembrolizumab
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Death
|
4
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pembrolizumab in Metastatic Anal Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=32 Participants
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
60.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 3 cycles on treatment. The median follow-up was 12.6 months. All registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)Population: The analysis dataset is comprised of all treated patients.
Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. A complete response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Pembrolizumab
n=32 Participants
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Overall Response Rate
|
11.1 probability
Interval 2.4 to 29.2
|
SECONDARY outcome
Timeframe: 36 monthsResponse rate in PD-L1 positive metastatic anal cancer patients will be evaluated by RECIST 1.1.
Outcome measures
| Measure |
Pembrolizumab
n=32 Participants
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
PD-L1 Positive Response Rate
|
13.0 probability
Interval 3.99 to 35.1
|
SECONDARY outcome
Timeframe: 36 monthsEvaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median overall survival.
Outcome measures
| Measure |
Pembrolizumab
n=32 Participants
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Overall Survival
|
13.6 months
Interval 6.5 to 17.7
|
SECONDARY outcome
Timeframe: 36 monthsEvaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median progression free survival.
Outcome measures
| Measure |
Pembrolizumab
n=32 Participants
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Progression Free Survival
|
2.2 months
Interval 1.9 to 4.1
|
SECONDARY outcome
Timeframe: Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment "Every 3 Weeks, from the time the informed consent is signed through 30 days following cessation of treatmentAssess how well pembrolizumab is tolerated in patients with metastatic anal cancer by evaluating adverse events by CTCAE v4.0. Safety was assessed every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
Outcome measures
| Measure |
Pembrolizumab
n=32 Participants
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab
|
25 Participants
|
Adverse Events
Pembrolizumab
Serious events: 13 serious events
Other events: 24 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=32 participants at risk
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
2/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
General disorders
Fatigue
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
General disorders
Sudden death NOS
|
6.2%
2/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Infections and infestations
Infections and Infestations
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Renal and urinary disorders
Urinary tract Obstruction
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Creatinine increased
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Reproductive system and breast disorders
Scrotal pain
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
Other adverse events
| Measure |
Pembrolizumab
n=32 participants at risk
Pembrolizumab is administered every 3 week intravenously. Dosage to be determined by physician
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32 • Number of events 4 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32 • Number of events 5 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
6/32 • Number of events 8 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Blood bilirubin increased
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Eye disorders
Blurred vision
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Creatinine increased
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
6/32 • Number of events 6 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
General disorders
Edema limbs
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
General disorders
Fatigue
|
34.4%
11/32 • Number of events 12 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
4/32 • Number of events 4 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
General disorders
Localized edema
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Lymphocyte count decreased
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 5 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
Neutrophil count decreased
|
3.1%
1/32 • Number of events 3 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
4/32 • Number of events 6 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.4%
3/32 • Number of events 10 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify (mouth sore)
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
|
Investigations
White blood cell decreased
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the consent form was signed every 3 weeks from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).
A serious adverse event was any adverse event occurring at any dose or during any use of pembrolizumab that: * Results in death; * Is life threatening; * Results in persistent or significant disability/incapacity; * Results in or prolongs an existing inpatient hospitalization; * Is a congenital anomaly/birth defect; * Is a new cancer (that is not a condition of the study); * Is associated with an overdose; * Is another important medical event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place