Trial · NCT03190213
Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma
NCT03190213, Phase 2, Terminated, University of Utah; results first posted 2020-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma. Trials, record NCT03190213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03190213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma
- NCT number
- NCT03190213
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Neuroendocrine Tumors
- Interventions
- Pembrolizumab Injection
- First posted
- 2017-06-16
- Last updated
- 2021-06-22
- Results first posted
- 2020-01-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days) | Overall response was measured using Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST). At baseline, lesions found on CT or MRI imaging are cataloged as "target" or "non-target" lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines Complete Response (irCR) as a complete disappearance of all lesions after baseline. Partial Response (irPR) is defined as a 30% or more decrease in the target lesion measurements. Overall response rate is defined the percentage of participants with a best response of irCR + irPR. |
| Secondary | Clinical Benefit Rate | planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days) | Clinical benefit was measured using irRECIST. At baseline, lesions found on CT or MRI imaging are cataloged as "target" or "non-target" lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines irCR as a complete disappearance of all lesions after baseline. irPR is defined as a 30% or more decrease in the target lesion measurements. Progressive Disease (irPD) is a defined as a 20% or more increase in target lesion measurements. Stable Disease (irSD) is neither a sufficient shrinkage to qualify as irPR or irCR nor an increase that would qualify as irPD. Clinical Benefit Rate is defined as the percentage of participants with a best response of irCR + irPR + irSD. |
| Secondary | Median Progression Free Survival | planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days) | Progression free survival (PFS) is the length of time during and after treatment that a participant lives and the disease does not get worse. PFS was measured as the time from first dose of pembrolizumab until disease progression by irRECIST criteria (\>= 20% increase in target lesion measurements), and is reported as the median number of days patients survived without disease progression as calculated by the Kaplan-Meier method. |
| Secondary | Median Overall Survival | planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days) | Overall survival (OS) is the length of time from the start of treatment that a participant lives. OS was measured as the time from first dose of pembrolizumab until the death of the participant or the end of follow-up (whichever was first), and is reported as the median number of days patients survived as calculated by the Kaplan-Meier method. This study was intended to follow participants up to four years after the initiation of study treatment, but the study and the follow-up period were terminated prematurely. The maximum follow up was 360 days. |
| Secondary | Number of Patients With Adverse Events Reported | planned for up to two years of treatment plus 90 days; actual time was up to 338 days (average of 170 days) | Adverse Events were reported using the Common Terminology Criteria for Adverse Events (CTCAE) version 4. Each adverse event reported is assigned a severity grade from 1 to 5, where 1 is mild, 2 is moderate, 3 is severe, 4 is life threatening, and 5 indicates the event resulted in death. The number of patients experiencing any Grade 1-2 event and the number of patients experiencing any Grade 3 event are reported. There were no Grade 4 or Grade 5 events reported on this study. AEs were reported during study treatment and up to 90 days after last dose of treatment. |
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 Response Rate | planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days) | percentage of participants | NUMBER | |
| SECONDARY | Clinical Benefit Rate | planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days) | percentage of participants | NUMBER | |
| SECONDARY | Median Progression Free Survival | planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days) | days | MEDIAN | |
| SECONDARY | Median Overall Survival | planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days) | days | MEDIAN | |
| SECONDARY | Number of Patients With Adverse Events Reported | planned for up to two years of treatment plus 90 days; actual time was up to 338 days (average of 170 days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Pembrolizumab: All Patients | 0 | 95% Confidence Interval 0 to 45.9 | percentage of participants | |
| Clinical Benefit Rate | Pembrolizumab: All Patients | 16.7 | 95% Confidence Interval 0.4 to 64.1 | percentage of participants | |
| Median Progression Free Survival | Pembrolizumab: All Patients | 42.5 | 95% Confidence Interval 40 to NA | days | |
| Median Overall Survival | Pembrolizumab: All Patients | 262 | 95% Confidence Interval 108 to NA | days | |
| Number of Patients With Adverse Events Reported | Pembrolizumab: All Patients | Grade 1-2 Event | 5 | Participants | |
| Number of Patients With Adverse Events Reported | Pembrolizumab: All Patients | Grade 3 Event | 5 | 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 | Pembrolizumab: All Patients | 6 | |
| Overall Study | COMPLETED | Pembrolizumab: All Patients | 6 | |
| Overall Study | NOT COMPLETED | Pembrolizumab: All Patients | 0 |
Source ClinicalTrials.gov
Adverse events37
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 | Abdominal pain | Gastrointestinal disorders | Pembrolizumab: All Patients | 3 | 6 | |
| other | Allergic reaction | Immune system disorders | Pembrolizumab: All Patients | 1 | 6 | |
| other | Anal pain | Gastrointestinal disorders | Pembrolizumab: All Patients | 1 | 6 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Pembrolizumab: All Patients | 2 | 6 | 3 |
| other | Autoimmune disorder | Immune system disorders | Pembrolizumab: All Patients | 1 | 6 | |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab: All Patients | 2 | 6 | |
| other | Dehydration | Metabolism and nutrition disorders | Pembrolizumab: All Patients | 1 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | Pembrolizumab: All Patients | 3 | 6 | 5 |
| other | Dyspepsia | Gastrointestinal disorders | Pembrolizumab: All Patients | 1 | 6 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Pembrolizumab: All Patients | 1 | 6 | 2 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab: All Patients | 2 | 6 |
| Total, other adverse events | Pembrolizumab: All Patients | 6 | 6 |
| Total, serious adverse events | Pembrolizumab: All Patients | 4 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT03190213
GET https://conductscience.org/api/trials/v1/NCT03190213/events?page=2