Colon CancerPhase 2NCT03801915
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
A Phase 2 study testing MVT-5873 and pancreatectomy or hepatectomy in people with Colon Cancer and Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Pancreatic Cancer, Cholangiocarcinoma
- What is being tested?
- MVT-5873 and pancreatectomy or hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 27 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed diagnoses of adenocarcinoma in one of the following scenarios:
- Primary tumors of the pancreas
- Primary tumors of the bile duct and ampulla
- Metastatic colorectal cancers to the liver
- Subjects must have disease resectable with a standard pancreatectomy (pancreaticoduodenectomy or distal pancreatectomy) or liver resection.
- Subjects may have received prior therapy, including neoadjuvant regimens.
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- Subjects must have serum Carbohydrate antigen 19-9 (CA 19-9) elevations greater than the upper limit of normal but less than 2500 U/mL.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Subjects must have adequate organ and marrow function as defined below:
- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/mcL
- platelets >90,000/mcL
- For subjects with Periampullary cancers that require a pancreaticoduodenectomy for complete tumor extirpation:
- total bilirubin <10 upper limit of normal (ULN)*
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase (SGPT) <5 X institutional upper limit of normal
- creatinine <1.5X institutional upper limit of normal
- Subjects with periampullary cancers typically present with biliary obstruction resulting in significant abnormalities in liver function tests that do not reflect liver dysfunction. These values normalize after tumor removal. They can be normalized pre-operatively with biliary stenting, but several large studies have demonstrated an increase in infectious complications with drainage. As such, a practice standard has been to avoid stenting until bilirubin level rises above 10 X ULN.
- For subjects with liver tumors (cholangiocarcinoma or metastatic colorectal cancer) requiring a hepatectomy for complete tumor extirpation:
- total bilirubin <2.5 X institutional upper limit of normal*
- AST(SGOT)/ALT(SGPT) <5 X institutional upper limit of normal*
- creatinine <1.5X institutional upper limit of normal
- Liver abnormalities in this range are consistent with parenchymal destruction from the tumor.
- For subjects with pancreas tumors that require a distal pancreatectomy for extirpation:
- total bilirubin <1.5 X institutional upper limit of normal*
- AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal*
- creatinine <1.5X institutional upper limit of normal
- Liver abnormalities in this range are consistent with pancreas cancer destruction from the tumor.
- The effects of MVT-5873 (HuMab-5B1) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 3 months after completion of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors.
Who cannot join
- Presence of disease outside the confines of a standard operation for subjects with periampullary cancers (pancreatic and cholangiocarcinoma).
- Presence of disease outside the liver for subjects with intrahepatic/hilar cholangiocarcinoma or metastatic colorectal cancer, other than a primary tumor for subjects with metastatic colorectal cancer.
- Subjects who are receiving any other investigational agents.
- Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from the last day of prior anticancer therapy, including chemotherapy, hormonal, investigational, and or biological therapies and irradiation.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
- requirements.
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- -Active concurrent malignancies within the last five years other than the primary tumor
- in subjects with metastatic colorectal cancer, basal or squamous cell skin carcinoma or non- medullary thyroid carcinoma.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of the MVT-5873. Because there is an unknown but potential
- Subjects with active, Hepatitis B or C infection because of the potential for increased liver toxicity given the damaging effects of the virus.
- Allergic to chimeric, humanized or human antibodies.
- Received live vaccine within 4 weeks prior to first date of study intervention.
- Infection requiring hospitalization or herpes zoster treatment within 2 weeks prior to the first date of study intervention.
- Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years prior to the first date of study intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease.
Read more
Objective:
To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease.
Eligibility:
Adults at least 18 years old with certain cancers and certain blood CA19-9 levels
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood and heart tests
- Scans
- Review of normal activities
- Review of tumor sample
- Pregnancy test
A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours.
Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research.
For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay.
After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.
Read the detailed description
Background:
- Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative, and patients frequently succumb to disease recurrence in the ensuing months to year(s) after the operation.
- Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer little demonstrable decreases in the rates of tumor recurrence.
- The concept and implementation of immediate perioperative therapy has not been evaluated given the serious concerns related to healing and recovery with standard cytotoxic chemotherapy and newer targeted agents.
- A significant percentage of metastatic colorectal cancers, and primary tumors of the pancreas and bile ducts express Sialyl Lewis, an epitope on the well-established tumor marker, Carbohydrate antigen 19-9 (CA19-9).
- MVT-5873, a fully human antibody against Sialyl Lewis, has displayed antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro, potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy in Phase 1 trials of patients with advanced inoperable Hepato-pancreato-biliary (HPB) cancers.
- MVT-5873 is well tolerated as a single agent; moderate elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) appear to be dose-limiting.
- Patients with resectable Sialyl Lewis-expressing cancers represent an ideal population to explore the use of perioperative MVT-5873 given moderate level of CA 19-9 elevations, and the potential for extension of recurrence-free survival.
Objectives:
- Document the safety of perioperative MVT-5873 in patients undergoing pancreas and liver resections.
- Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for patients with operable CA 19-9-producing cancers.
Eligibility:
- Histologically or cytologically confirmed adenocarcinoma of the
- Colon (metastatic to liver)
- Pancreas
- Bile Ducts (Cholangiocarcinoma)
- Serum CA19-9 levels greater than the upper limit of normal, but less than 2500.
- Disease amenable to complete surgical extirpation.
Design:
-Pre-operative one-time treatment with MVT-5873, resection to remove all demonstrable disease in the liver, bile ducts and pancreas, and continuing MVT-5873 mono-therapy until off treatment criteria are met.
- Conditions
- Colon Cancer, Pancreatic Cancer, Cholangiocarcinoma, Metastatic Colon Carcinoma, Liver Metastasis
- Being tested
- MVT-5873, pancreatectomy or hepatectomy
- Keywords
- Well Tolerated Agent, Pancreas and Liver Resections, Recurrence-Free Survival
- Medical subject headings
- Colonic Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVT-5873Drug
Also called HuMab-5B1
1 mg/kg or 3 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
pancreatectomy or hepatectomyProcedure or surgery
Pancreatectomy or hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Experimental | Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment Receives: Drug: MVT-5873; Procedure: pancreatectomy or hepatectomy |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Experimental | Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment Receives: Drug: MVT-5873; Procedure: pancreatectomy or hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Disease Recurrence At 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.
Measured: 1 year
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
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.
Measured: 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.
Secondary outcomes (1)
Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873
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.
Measured: An average of 15.17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start13 Nov 2019
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Jonathan Hernandez, M.D., National Cancer Institute (NCI)
- Investigators
- Jonathan M Hernandez, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801915
- Sponsor's protocol ID
- 190039
- Other IDs
- 19-C-0039
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2019
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).
Publications
Gupta S, McDonald JD, Ayabe RI, Khan TM, Gamble LA, Sinha S, Hannah C, Blakely AM, Davis JL, Hernandez JM. Targeting CA 19-9 with a humanized monoclonal antibody at the time of surgery may decrease recurrence rates for patients undergoing resections for pancreatic cancer, cholangiocarcinoma and metastatic colorectal cancer. J Gastrointest Oncol. 2020 Apr;11(2):231-235. doi: 10.21037/jgo.2020.02.01.
PubMed 32399263
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03801915
- Acronym / sponsor ID
- 190039
- Conditions
- Colon Cancer, Pancreatic Cancer, Cholangiocarcinoma, Metastatic Colon Carcinoma, Liver Metastasis
- Keywords
- Well Tolerated Agent, Pancreas and Liver Resections, Recurrence-Free Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease.
Objective:
To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease.
Eligibility:
Adults at least 18 years old with certain cancers and certain blood CA19-9 levels
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood and heart tests
- Scans
- Review of normal activities
- Review of tumor sample
- Pregnancy test
A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours.
Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research.
For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay.
After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.
Detailed description
Background:
- Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative, and patients frequently succumb to disease recurrence in the ensuing months to year(s) after the operation.
- Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer little demonstrable decreases in the rates of tumor recurrence.
- The concept and implementation of immediate perioperative therapy has not been evaluated given the serious concerns related to healing and recovery with standard cytotoxic chemotherapy and newer targeted agents.
- A significant percentage of metastatic colorectal cancers, and primary tumors of the pancreas and bile ducts express Sialyl Lewis, an epitope on the well-established tumor marker, Carbohydrate antigen 19-9 (CA19-9).
- MVT-5873, a fully human antibody against Sialyl Lewis, has displayed antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro, potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy in Phase 1 trials of patients with advanced inoperable Hepato-pancreato-biliary (HPB) cancers.
- MVT-5873 is well tolerated as a single agent; moderate elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) appear to be dose-limiting.
- Patients with resectable Sialyl Lewis-expressing cancers represent an ideal population to explore the use of perioperative MVT-5873 given moderate level of CA 19-9 elevations, and the potential for extension of recurrence-free survival.
Objectives:
- Document the safety of perioperative MVT-5873 in patients undergoing pancreas and liver resections.
- Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for patients with operable CA 19-9-producing cancers.
Eligibility:
- Histologically or cytologically confirmed adenocarcinoma of the
- Colon (metastatic to liver)
- Pancreas
- Bile Ducts (Cholangiocarcinoma)
- Serum CA19-9 levels greater than the upper limit of normal, but less than 2500.
- Disease amenable to complete surgical extirpation.
Design:
-Pre-operative one-time treatment with MVT-5873, resection to remove all demonstrable disease in the liver, bile ducts and pancreas, and continuing MVT-5873 mono-therapy until off treatment criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Experimental | Drug: MVT-5873, Procedure: pancreatectomy or hepatectomyPre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Experimental | Drug: MVT-5873, Procedure: pancreatectomy or hepatectomyPre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Subjects must have histologically or cytologically confirmed diagnoses of adenocarcinoma in one of the following scenarios:
- Subjects must have disease resectable with a standard pancreatectomy (pancreaticoduodenectomy or distal pancreatectomy) or liver resection.
- Subjects may have received prior therapy, including neoadjuvant regimens.
- Subjects must have serum Carbohydrate antigen 19-9 (CA 19-9) elevations greater than the upper limit of normal but less than 2500 U/mL.
- Age greater than or equal to 18 years.
Key exclusion criteria (14 listed)
- Presence of disease outside the confines of a standard operation for subjects with periampullary cancers (pancreatic and cholangiocarcinoma).
- Presence of disease outside the liver for subjects with intrahepatic/hilar cholangiocarcinoma or metastatic colorectal cancer, other than a primary tumor for subjects with metastatic colorectal cancer.
- Subjects who are receiving any other investigational agents.
- Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from the last day of prior anticancer therapy, including chemotherapy, hormonal, investigational, and or biological therapies and irradiation.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVT-5873Also: HuMab-5B11 mg/kg or 3 mg/kg for pre-operative dose, 1 mg/kg during post-operative period | Drug | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1), Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) |
| pancreatectomy or hepatectomyPancreatectomy or hepatectomy | Procedure or surgery | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1), Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) |
Primary outcome
Number of Participants With Disease Recurrence At 1 Year
Time frame: 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.
Number of Grade 3-5 Adverse Events Related and/or Not Related to Drug
Time frame: 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.
1 secondary outcome
Define Disease Free Survival (DFS) for Participants Treated With Preoperative MVT-5873
Time frame: An average of 15.17 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32399263Gupta S, McDonald JD, Ayabe RI, Khan TM, Gamble LA, Sinha S, Hannah C, Blakely AM, Davis JL, Hernandez JM. Targeting CA 19-9 with a humanized monoclonal antibody at the time of surgery may decrease recurrence rates for patients undergoing resections for pancreatic cancer, cholangiocarcinoma and metastatic colorectal cancer. J Gastrointest Oncol. 2020 Apr;11(2):231-235. doi: 10.21037/jgo.2020.02.01.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M Hernandez, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVT-5873 and pancreatectomy or hepatectomy in people with Colon Cancer and Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Disease Recurrence At 1 Year (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.