Trial · NCT03043664
Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
NCT03043664, Phase 1, Phase 2, Completed, Duke University; results first posted 2022-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors. Trials, record NCT03043664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03043664
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
- NCT number
- NCT03043664
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumors
- Interventions
- Lanreotide, Pembrolizumab
- First posted
- 2017-02-06
- Last updated
- 2023-06-29
- Results first posted
- 2022-09-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Approximately every 12 weeks until study completion (up to 2 years) | ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion. A 90% LCB of \< 0.1 will be considered not to be of clinical value. If the 90% LCB is ≥ 0.1, the regimen will be considered efficacious. |
| Secondary | Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment | First 12 weeks of treatment | Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Secondary | Months of Progression-free Survival (PFS) | Up to 3 years | Months from treatment start date until the date of first documented radiographic progression or date of death from any cause (whichever is first); assessed up to 48 weeks after the last subject has finished study drug regimen. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. |
| Secondary | Months of Overall Survival (OS) | Up to 59 months | Months from treatment start date until the date of death from any cause; assessed up to 48 weeks after the last subject has finished the study drug regimen |
| Secondary | ORR as Measured by Immune-related Response Criteria (irRC) | Approximately every 12 weeks until study completion (up to 2 years) | Treatment response as assessed by irRC instead of RECIST v1.1. ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as complete disappearance of all lesions (whether measurable or not, and no new lesions), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date first documented. Partial response is defined as a decrease in tumor burden ≥ 50% relative to baseline, confirmed by a consecutive assessment at least 4 weeks after first documentation. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion. |
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 | Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Approximately every 12 weeks until study completion (up to 2 years) | proportion of participants | NUMBER | |
| SECONDARY | Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment | First 12 weeks of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Months of Progression-free Survival (PFS) | Up to 3 years | months | MEDIAN | |
| SECONDARY | Months of Overall Survival (OS) | Up to 59 months | months | MEDIAN | |
| SECONDARY | ORR as Measured by Immune-related Response Criteria (irRC) | Approximately every 12 weeks until study completion (up to 2 years) | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Somatuline Depot and Keytruda | 0.045 | 90% Confidence Interval 0 to 0.12 | proportion of participants | |
| Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment | Somatuline Depot and Keytruda | 0 | Participants | ||
| Months of Progression-free Survival (PFS) | Somatuline Depot and Keytruda | 5.04 | 95% Confidence Interval 2.7 to 11.3 | months | |
| Months of Overall Survival (OS) | Somatuline Depot and Keytruda | 28.6 | 95% Confidence Interval 21.0 to NA | months | |
| ORR as Measured by Immune-related Response Criteria (irRC) | Somatuline Depot and Keytruda | 0.045 | 90% Confidence Interval 0 to 0.12 | proportion of 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 | Somatuline Depot and Keytruda | 22 | |
| Overall Study | COMPLETED | Somatuline Depot and Keytruda | 21 | |
| Overall Study | NOT COMPLETED | Somatuline Depot and Keytruda | 1 |
Source ClinicalTrials.gov
Adverse events64
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 | Somatuline Depot and Keytruda | 3 | 22 | 3 |
| other | Chest pain - cardiac | Cardiac disorders | Somatuline Depot and Keytruda | 1 | 22 | 1 |
| other | Palpitations | Cardiac disorders | Somatuline Depot and Keytruda | 1 | 22 | 1 |
| other | Pericardial effusion | Cardiac disorders | Somatuline Depot and Keytruda | 1 | 22 | 1 |
| other | Hypothyroidism | Endocrine disorders | Somatuline Depot and Keytruda | 5 | 22 | 5 |
| other | Blurred vision | Eye disorders | Somatuline Depot and Keytruda | 1 | 22 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Somatuline Depot and Keytruda | 6 | 22 | 6 |
| other | Ascites | Gastrointestinal disorders | Somatuline Depot and Keytruda | 2 | 22 | 2 |
| other | Bloating | Gastrointestinal disorders | Somatuline Depot and Keytruda | 1 | 22 | 1 |
| other | Constipation | Gastrointestinal disorders | Somatuline Depot and Keytruda | 2 | 22 | 2 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Somatuline Depot and Keytruda | 15 | 22 |
| Total, other adverse events | Somatuline Depot and Keytruda | 22 | 22 |
| Total, serious adverse events | Somatuline Depot and Keytruda | 6 | 22 |
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/NCT03043664
GET https://conductscience.org/api/trials/v1/NCT03043664/events?page=2