Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery (NCT NCT02949219)
NCT ID: NCT02949219
Last Updated: 2024-08-22
Results Overview
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
1 year (up to 18 cycles)
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab)
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab)
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab)
n=40 Participants
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 13.16 • n=39 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
ECOG Performance Status
0
|
17 Participants
n=39 Participants
|
|
ECOG Performance Status
1
|
23 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 year (up to 18 cycles)The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=40 Participants
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Confirmed Response Rate
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
SECONDARY outcome
Timeframe: From study entry to the first of either disease progression or death from any cause, assessed up to 2 yearsProgression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=40 Participants
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival
|
2.8 months
Interval 2.7 to 4.2
|
SECONDARY outcome
Timeframe: From study entry to death from any cause, assessed up to 2 yearsOverall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=40 Participants
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
6.9 months
Interval 5.1 to 17.1
|
SECONDARY outcome
Timeframe: Up to 2 yearsnumber of participants who experienced at least one grade 3 or higher adverse events regardless of attribution assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.03
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=40 Participants
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsCorrelated with clinical data (i.e. response, overall survival, progression free survival, adverse events). These correlations will be done using the Chi-square or Fisher?s exact test for categorical data and Kaplan-Meier methods (including the log-rank test) for the survival endpoints. Univariate Cox regression models will also be done to assess for marker effects on survival endpoints. Descriptive statistics and graphical methods will be used to summarize the data as well. All these analyses will be done overall and by MMR/microsatellite instability status.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Pembrolizumab)
Serious events: 21 serious events
Other events: 34 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab)
n=40 participants at risk
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
2/40 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
2/40 • Number of events 3 • Up to 2 years
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
5.0%
2/40 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
7.5%
3/40 • Number of events 5 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • Number of events 2 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
7.5%
3/40 • Number of events 3 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
5/40 • Number of events 6 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
7.5%
3/40 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Stroke
|
5.0%
2/40 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.0%
2/40 • Number of events 3 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
2/40 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Treatment (Pembrolizumab)
n=40 participants at risk
Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • Number of events 4 • Up to 2 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.5%
1/40 • Number of events 3 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
15.0%
6/40 • Number of events 10 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
27.5%
11/40 • Number of events 45 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
1/40 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 7 • Up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
General disorders
Fatigue
|
7.5%
3/40 • Number of events 7 • Up to 2 years
|
|
General disorders
Localized edema
|
2.5%
1/40 • Number of events 9 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.5%
1/40 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Papulopustular rash
|
5.0%
2/40 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
27.5%
11/40 • Number of events 33 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
70.0%
28/40 • Number of events 97 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
20/40 • Number of events 39 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
17.5%
7/40 • Number of events 10 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
2.5%
1/40 • Number of events 3 • Up to 2 years
|
|
Investigations
Weight loss
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.5%
1/40 • Number of events 6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
1/40 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 11 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
2/40 • Number of events 6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Dysesthesia
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
2/40 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.5%
3/40 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.5%
1/40 • Number of events 1 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place