Trial · NCT03000179
Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma
NCT03000179, Phase 2, Terminated, Vanderbilt-Ingram Cancer Center; results first posted 2022-04-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma. Trials, record NCT03000179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03000179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma
- NCT number
- NCT03000179
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Adenocarcinoma
- Interventions
- Avelumab
- First posted
- 2016-12-21
- Last updated
- 2022-04-14
- Results first posted
- 2022-04-14
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 as Measured Using RECIST 1.1 | Measured every 8 weeks through study completion, an average of 1 year | Response rate is the proportion of patients with overall complete (CR) or partial response(PR) among patients with valuable response outcome. Overall response will consider both target and non-target lesions, as well as new lesions. Target lesions by CT/MRI: CR: Disappearance of all target lesions. PR: \>= 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions, In addition, the sum must also demonstrate an absolute increase of at least 5 mm or appearance of new lesions. Non-target lesions: CR: Disappearance of all target lesions. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of applicable tumor marker level above the normal limits. PD: progression of existing non-target lesions. |
| Primary | Number of Patients With Each Worst-Grade Toxicity | On-study date to 30 days following final dose of study drug, or until the event is resolved, stabilized, or determined to be irreversible by the participating investigator if beyond 30 days. | To describe the safety profile of avelumab monotherapy in patients with advanced or metastatic small intestinal adenocarcinoma |
| Secondary | Overall Survival | Every 3 months after completing treatment up to 5 years | On study date until death from any cause |
| Secondary | Progression Free Survival | On-study date to lesser of date of progression or date of death from any cause measured up to 3 years after treatment | On-study date until disease progression or death. Progression is \>= 20% increase in the sum of diameters of target lesions or non-target lesions, or appearance of new lesions. |
| Secondary | Duration of Response | Date of first partial or complete response as defined by RECIST 1.1 criteria to date of recurrence or disease progression up to 3 years | Time from tumor response date to disease progression or death for any reason. |
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 as Measured Using RECIST 1.1 | Measured every 8 weeks through study completion, an average of 1 year | Patients with advanced small intestinal adenocarcinoma or ampullary tumors, efficacy-evaluable. | proportion of participants | NUMBER |
| PRIMARY | Number of Patients With Each Worst-Grade Toxicity | On-study date to 30 days following final dose of study drug, or until the event is resolved, stabilized, or determined to be irreversible by the participating investigator if beyond 30 days. | all participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Every 3 months after completing treatment up to 5 years | all participants | months | MEDIAN |
| SECONDARY | Progression Free Survival | On-study date to lesser of date of progression or date of death from any cause measured up to 3 years after treatment | all participants | months | MEDIAN |
| SECONDARY | Duration of Response | Date of first partial or complete response as defined by RECIST 1.1 criteria to date of recurrence or disease progression up to 3 years | Patients who had partial response. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate as Measured Using RECIST 1.1 | Avelumab Monotherapy | 0.29 | 95% Confidence Interval 0.08 to 0.64 | proportion of participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Anemia, Grade 1 | 2 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Fatigue, Grade2 | 1 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Infusion related reaction. Grade2 | 2 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Alanine aminotransferase increased, Grade 1 | 1 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Alkaline phosphatase increased, Grade 1 | 1 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Anorexia, Grade 2 | 1 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Blood bilirubin increased, Grade1 | 1 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Diarrhea, Grade 1 | 1 | Participants | |
| Number of Patients With Each Worst-Grade Toxicity | Avelumab Monotherapy | Diabetic ketoacidosis, Grade 4 | 1 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avelumab Monotherapy | 8 | |
| Overall Study | COMPLETED | Avelumab Monotherapy | 6 | |
| Overall Study | NOT COMPLETED | Avelumab Monotherapy | 2 |
Source ClinicalTrials.gov
Adverse events89
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 | Avelumab Monotherapy | 5 | 8 | 7 |
| other | Nausea | Gastrointestinal disorders | Avelumab Monotherapy | 5 | 8 | 7 |
| other | Vomiting | Gastrointestinal disorders | Avelumab Monotherapy | 4 | 8 | 6 |
| other | Constipation | Gastrointestinal disorders | Avelumab Monotherapy | 2 | 8 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Avelumab Monotherapy | 2 | 8 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Avelumab Monotherapy | 1 | 8 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Avelumab Monotherapy | 1 | 8 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Avelumab Monotherapy | 1 | 8 | 1 |
| other | Flatulence | Gastrointestinal disorders | Avelumab Monotherapy | 1 | 8 | 1 |
| other | Gastrointestinal fistula | Gastrointestinal disorders | Avelumab Monotherapy | 1 | 8 | 1 |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avelumab Monotherapy | 6 | 8 |
| Total, other adverse events | Avelumab Monotherapy | 8 | 8 |
| Total, serious adverse events | Avelumab Monotherapy | 7 | 8 |
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/NCT03000179
GET https://conductscience.org/api/trials/v1/NCT03000179/events?page=2