Trial · NCT03801915
Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
NCT03801915, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers. Trials, record NCT03801915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03801915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
- NCT number
- NCT03801915
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Colon Cancer, Pancreatic Cancer, Cholangiocarcinoma, Metastatic Colon Carcinoma, Liver Metastasis
- Interventions
- MVT-5873, pancreatectomy or hepatectomy
- First posted
- 2019-01-14
- Last updated
- 2023-03-21
- Results first posted
- 2023-03-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Disease Recurrence At 1 Year | 1 year | Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI. |
| Primary | Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events. |
| Secondary | Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873 | An average of 15.17 months | Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
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 | Number of Participants With Disease Recurrence At 1 Year | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively. | Adverse events | NUMBER | |
| SECONDARY | Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873 | An average of 15.17 months | 5/8 participants were analyzed in cohort 1 because 2 participants were found to have peritoneal metastases on Day 0 and were taken off study, and 1 participant was taken off study due to study closure. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Disease Recurrence At 1 Year | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | Participants | ||
| Number of Participants With Disease Recurrence At 1 Year | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 | Participants | ||
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Grade 3 Abdominal pain - Not Related | 2 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Grade 3 Abdominal pain - Not Related | 1 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Grade 3 Abdominal infection - Not Related | 1 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Grade 3 Abdominal infection - Not Related | 0 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Grade 3 Alanine aminotransferase increased - Not Related | 2 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Grade 3 Alanine aminotransferase increased - Not Related | 1 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Grade 3 Alkaline phosphatase increased - Not Related | 0 | Adverse events | |
| Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Grade 3 Alkaline phosphatase increased - Not Related | 1 | Adverse events |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 8 | |
| Overall Study | STARTED | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | |
| Overall Study | STARTED | Enrolled But Not Treated | 1 | |
| Overall Study | COMPLETED | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 5 | |
| Overall Study | COMPLETED | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 | |
| Overall Study | COMPLETED | Enrolled But Not Treated | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 3 | |
| Overall Study | NOT COMPLETED | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | |
| Overall Study | NOT COMPLETED | Enrolled But Not Treated | 1 |
Source ClinicalTrials.gov
Adverse events100
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 infection | Infections and infestations | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 1 | 8 | 1 |
| other | Abdominal infection | Infections and infestations | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | 1 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | 8 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | 1 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 1 | 8 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 | 1 | 0 |
| other | Alanine aminotransferase increased | Investigations | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 6 | 8 | 16 |
| other | Alanine aminotransferase increased | Investigations | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | 1 | 5 |
| other | Alkaline phosphatase increased | Investigations | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 4 | 8 | 11 |
| other | Alkaline phosphatase increased | Investigations | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | 1 | 10 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 1 | 8 |
| Total, all-cause mortality | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 | 1 |
| Total, other adverse events | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 7 | 8 |
| Total, other adverse events | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | 1 |
| Total, serious adverse events | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | 8 |
| Total, serious adverse events | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32399263 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) vs Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1): Number of Participants With Disease Recurrence At 1 Year | Trial comparisons |
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) vs Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1): Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) vs Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1): deaths from any cause | Trial comparisons |
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) vs Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1): 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/NCT03801915
GET https://conductscience.org/api/trials/v1/NCT03801915/results?page=2