Trial · NCT03136055
Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
NCT03136055, Phase 2, Completed, University of California, San Francisco; results first posted 2022-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas. Trials, record NCT03136055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03136055
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
- NCT number
- NCT03136055
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- High Grade Malignant Neuroendocrine Carcinoma (Diagnosis)
- Interventions
- Pembrolizumab, Irinotecan, Paclitaxel
- First posted
- 2017-05-02
- Last updated
- 2022-12-27
- Results first posted
- 2022-12-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Approximately 2 years | ORR is defined as the percentage of participants in the analysis population who demonstrated complete response (CR) or partial response (PR) radiographically according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator. The analysis will include all subjects treated (ITT) who received at least one dose of the study treatment. If the final study consists of both Part A and Part B, the analysis will be done separately for each part. |
| Secondary | Overall Survival (OS) | Over the duration of the study, which is estimated to be approximately 32 months. | Overall survival is defined as the time from the first day of study treatment with protocol therapy to the date of death due to any cause. Kaplan-Meier method will be used to summarize OS. Median OS and its 95% confidence interval will be obtained for Part A and B (if available) separately. |
| Secondary | Duration of Response (DOR) | Over the duration of the study, which is estimated to be approximately 32 months. | Duration of Response is defined as the time from the date of first response (CR or PR) until the date of disease progression or death. Duration of response will be reported for Part A and B (if available) separately. Only patients who have a demonstrated response will be used in final analysis. |
| Secondary | Progression Free Survival (PFS) | Over the duration of the study, which is estimated to be approximately 32 months. | Progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by RECIST v1.1 for PFS. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment. Kaplan-Meier method will be used to summarize progression median PFS with 95% confidence interval for Part A and B (if available) separately. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Approximately 2 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | Over the duration of the study, which is estimated to be approximately 32 months. | months | MEDIAN | |
| SECONDARY | Duration of Response (DOR) | Over the duration of the study, which is estimated to be approximately 32 months. | Only 1 participant in Part A, and 1 participant in Part B obtained CR or PR | months | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Over the duration of the study, which is estimated to be approximately 32 months. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Part A: Pembrolizumab Only | 7 | 95% Confidence Interval 0.02 to 33.9 | percentage of participants | |
| Overall Response Rate (ORR) | Part B: Pembrolizumab + Chemotherapy | 5 | 95% Confidence Interval 0 to 22.8 | percentage of participants | |
| Overall Survival (OS) | Part A: Pembrolizumab Only | 7.8 | 95% Confidence Interval 3.1 to NA | months | |
| Overall Survival (OS) | Part B: Pembrolizumab + Chemotherapy | 4.8 | 95% Confidence Interval 4.1 to 8.2 | months | |
| Duration of Response (DOR) | Part A: Pembrolizumab Only | 18.9 | months | ||
| Duration of Response (DOR) | Part B: Pembrolizumab + Chemotherapy | 6.71 | months | ||
| Progression Free Survival (PFS) | Part A: Pembrolizumab Only | 1.8 | 95% Confidence Interval 1.7 to 21.4 | months | |
| Progression Free Survival (PFS) | Part B: Pembrolizumab + Chemotherapy | 2 | 95% Confidence Interval 1.9 to 3.4 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Pembrolizumab Only | 14 | |
| Overall Study | STARTED | Part B: Pembrolizumab + Chemotherapy | 22 | |
| Overall Study | COMPLETED | Part A: Pembrolizumab Only | 14 | |
| Overall Study | COMPLETED | Part B: Pembrolizumab + Chemotherapy | 22 | |
| Overall Study | NOT COMPLETED | Part A: Pembrolizumab Only | 0 | |
| Overall Study | NOT COMPLETED | Part B: Pembrolizumab + Chemotherapy | 0 |
Source ClinicalTrials.gov
Adverse events218
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 | Part A: Pembrolizumab Only | 5 | 14 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Part B: Pembrolizumab + Chemotherapy | 10 | 22 | 11 |
| other | Diarrhea | Gastrointestinal disorders | Part A: Pembrolizumab Only | 2 | 14 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Part B: Pembrolizumab + Chemotherapy | 12 | 22 | 20 |
| other | Nausea | Gastrointestinal disorders | Part A: Pembrolizumab Only | 4 | 14 | 4 |
| other | Nausea | Gastrointestinal disorders | Part B: Pembrolizumab + Chemotherapy | 10 | 22 | 11 |
| other | Constipation | Gastrointestinal disorders | Part A: Pembrolizumab Only | 5 | 14 | 5 |
| other | Constipation | Gastrointestinal disorders | Part B: Pembrolizumab + Chemotherapy | 7 | 22 | 9 |
| other | Vomiting | Gastrointestinal disorders | Part A: Pembrolizumab Only | 2 | 14 | 2 |
| other | Vomiting | Gastrointestinal disorders | Part B: Pembrolizumab + Chemotherapy | 8 | 22 | 12 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Pembrolizumab Only | 11 | 14 |
| Total, all-cause mortality | Part B: Pembrolizumab + Chemotherapy | 21 | 22 |
| Total, other adverse events | Part A: Pembrolizumab Only | 14 | 14 |
| Total, other adverse events | Part B: Pembrolizumab + Chemotherapy | 22 | 22 |
| Total, serious adverse events | Part A: Pembrolizumab Only | 1 | 14 |
| Total, serious adverse events | Part B: Pembrolizumab + Chemotherapy | 6 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37208512 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A: Pembrolizumab Only vs Part B: Pembrolizumab + Chemotherapy: deaths from any cause | Trial comparisons |
| Part A: Pembrolizumab Only vs Part B: Pembrolizumab + Chemotherapy: serious adverse events | Trial comparisons |
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/NCT03136055
GET https://conductscience.org/api/trials/v1/NCT03136055/events?page=2