TriangleNCT02949219 · STUDY IN CONTEXT
Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Correlated 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.
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.
Progression 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.
Overall 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.
number 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
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- trial label
- Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0004
- source section id
- NCT02949219-om-0004
- source outcome index
- 4
- endpoint
- Biomarker Levels
- endpoint definition
- Correlated 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.
- time origin
- Up to 5 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0000
- source section id
- NCT02949219-om-0000
- source outcome index
- 0
- endpoint
- Overall Confirmed Response Rate
- endpoint definition
- 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.
- time origin
- 1 year (up to 18 cycles)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0001
- source section id
- NCT02949219-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival
- endpoint definition
- Progression 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.
- time origin
- From study entry to the first of either disease progression or death from any cause, assessed up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0002
- source section id
- NCT02949219-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Overall 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.
- time origin
- From study entry to death from any cause, assessed up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0003
- source section id
- NCT02949219-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution
- endpoint definition
- number 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
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- 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.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02949219-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- 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.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02949219-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- 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.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02949219-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- 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.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02949219-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT02949219
- harm key
- EG000
- source section id
- NCT02949219-ae
- event group key
- EG000
- event group label
- Treatment (Pembrolizumab)
- serious affected
- 21
- serious at risk
- 40
- other affected
- 34
- other at risk
- 40
- frequency threshold
- 0
- collection period
- Up to 2 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice