Trial · NCT02949219
Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
NCT02949219, Phase 2, Unknown, Academic and Community Cancer Research United; results first posted 2020-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery. Trials, record NCT02949219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02949219
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
- NCT number
- NCT02949219
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
- Metastatic Small Intestinal Adenocarcinoma, Recurrent Small Intestinal Carcinoma, Unresectable Small Intestinal Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Pembrolizumab
- First posted
- 2016-10-31
- Last updated
- 2024-08-22
- Results first posted
- 2020-01-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Confirmed Response Rate | 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. |
| Secondary | Progression Free Survival | From study entry to the first of either disease progression or death from any cause, assessed up to 2 years | 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. |
| Secondary | Overall Survival | From study entry to death from any cause, assessed up to 2 years | 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. |
| Secondary | Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution | Up to 2 years | 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 |
| Other | Biomarker Levels | Up to 5 years | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Confirmed Response Rate | 1 year (up to 18 cycles) | percentage of participants | NUMBER | |
| SECONDARY | Progression Free Survival | From study entry to the first of either disease progression or death from any cause, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Overall Survival | From study entry to death from any cause, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Biomarker Levels | Up to 5 years |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Confirmed Response Rate | Treatment (Pembrolizumab) | 7.5 | 95% Confidence Interval 1.6 to 20.4 | percentage of participants | |
| Progression Free Survival | Treatment (Pembrolizumab) | 2.8 | 95% Confidence Interval 2.7 to 4.2 | months | |
| Overall Survival | Treatment (Pembrolizumab) | 6.9 | 95% Confidence Interval 5.1 to 17.1 | months | |
| Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution | Treatment (Pembrolizumab) | 25 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Pembrolizumab) | 41 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab) | 40 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab) | 1 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Pembrolizumab) | 2 | 40 | 4 |
| other | Endocrine disorders - Other, specify | Endocrine disorders | Treatment (Pembrolizumab) | 1 | 40 | 3 |
| other | Hyperthyroidism | Endocrine disorders | Treatment (Pembrolizumab) | 6 | 40 | 10 |
| other | Hypothyroidism | Endocrine disorders | Treatment (Pembrolizumab) | 11 | 40 | 45 |
| other | Abdominal distension | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 40 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Pembrolizumab) | 3 | 40 | 7 |
| other | Ascites | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 40 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 40 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 40 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Pembrolizumab) | 1 | 40 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab) | 28 | 40 |
| Total, other adverse events | Treatment (Pembrolizumab) | 34 | 40 |
| Total, serious adverse events | Treatment (Pembrolizumab) | 21 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02949219
GET https://conductscience.org/api/trials/v1/NCT02949219/events?page=2