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Monoclonal Antibodies
VX15/2503 + Immunotherapy for Pancreatic and Colorectal Cancer
Phase 1
Waitlist Available
Led By Olatunji Alese, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor must be confirmed to be microsatellite stable (MSS); if not already reported at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, we will be able to perform this at Emory University
Calculated creatinine clearance of ≥ 50 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years from date of last treatment dose
Awards & highlights
Study Summary
This trial is testing the combination of three drugs to treat pancreatic and colorectal cancer.
Who is the study for?
This trial is for adults with stage I-III pancreatic cancer eligible for surgery or stage IV colorectal cancer that has spread to the liver but can still be surgically removed. Participants must not have had immunotherapy before, no chemotherapy within 2 weeks prior to starting the trial, and should have a good performance status. They need normal blood counts and organ function tests, agree to use contraception if of childbearing potential, and cannot be on certain medications or have severe medical conditions.Check my eligibility
What is being tested?
The study is testing how well VX15/2503 (an anti-SEMA4D monoclonal antibody) works alone or combined with ipilimumab or nivolumab in treating resectable pancreatic and colorectal cancers. These drugs are designed to stop tumor growth by interfering with specific pathways in cancer cells. The trial will randomly assign participants to different treatment groups.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation of organs, skin rash, diarrhea; infusion-related symptoms like fever or chills; fatigue; hormonal gland problems leading to changes in mood or behavior; possible liver enzyme elevation indicating liver irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is confirmed to be microsatellite stable.
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My kidneys are functioning well.
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My colorectal cancer is at stage IV and confirmed by biopsy.
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I am of childbearing age and have a negative pregnancy test.
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My cancer can be removed with surgery.
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I have never received immunotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My pancreatic cancer is confirmed and is at stage I, II, or III.
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I agree to use effective birth control during and for 3 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years from date of last treatment dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years from date of last treatment dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate treatment effects of the study drugs on tumor cluster of differentiation 8+ (CD8+) T cell infiltration between the treatment groups.
Secondary outcome measures
Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events scale version 4.0
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (VX15/2503, nivolumab, surgery)Experimental Treatment3 Interventions
Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and nivolumab IV over 60 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.
Group II: Arm III (VX15/2503, ipilimumab, surgery)Experimental Treatment3 Interventions
Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.
Group III: Arm II (VX15/2503, surgery)Experimental Treatment2 Interventions
Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.
Group IV: Arm I (surgery)Active Control1 Intervention
Patients undergo surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
Anti-SEMA4D Monoclonal Antibody VX15/2503
2017
Completed Phase 1
~10
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,143 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,578 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,563 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is confirmed to be microsatellite stable.Your platelet count is at least 100,000 per microliter of blood.My kidneys are functioning well.I have not had serious infections needing treatment in the last week.It's hard to give you the study drug through your veins.Your total bilirubin level is not more than 1.5 times the upper limit of normal.I cannot have surgery because of other health problems.I am of childbearing age and have a negative pregnancy test.I have had an organ or bone marrow transplant from another person.I have an autoimmune disease, but it's either mild or not expected to come back without a trigger.I am not pregnant or breastfeeding.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a bleeding disorder or a condition affecting blood clotting.I haven't received vaccines not related to cancer within 4 weeks before or after getting ipilimumab.I am willing and able to follow the study's schedule and procedures.My colorectal cancer is at stage IV and confirmed by biopsy.I haven't taken any experimental drugs recently.My cancer can be removed with surgery.I haven't had cancer chemotherapy in the last 2 weeks.My hemoglobin level is at least 9.0 g/dL.My liver cancer can be removed with surgery, and if there's cancer outside the liver, it's also removable.I haven't had cancer chemotherapy in the last 2 weeks.My blood clotting time is normal or near normal, and if I'm on blood thinners, it's only low molecular weight heparin.I have never received immunotherapy.I will use contraception during and for 3 months after the study.Your AST and ALT levels in the blood should be less than 2.5 times the upper limit of normal.You have enough infection-fighting white blood cells in your body.I am fully active or restricted in physically strenuous activity but can do light work.You have had serious allergic reactions to other similar types of medication.My pancreatic cancer is confirmed and is at stage I, II, or III.I have had chemotherapy before surgery, but no radiation with it.Your albumin level is at least 3.0 grams per deciliter.I agree to use effective birth control during and for 3 months after the study.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am on long-term immunosuppressants like cyclosporine.Your kidney function, measured by a blood test called serum creatinine, needs to be within a certain range.I have been cancer-free for over 5 years, or had a cancer that was completely removed.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (surgery)
- Group 2: Arm IV (VX15/2503, nivolumab, surgery)
- Group 3: Arm III (VX15/2503, ipilimumab, surgery)
- Group 4: Arm II (VX15/2503, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial available to potential participants?
"According to records on clinicaltrials.gov, recruitment for this medical experiment has closed; it was originally posted on December 15th 2017 and last updated in 2021. Although no longer open to participation, 5027 other trials are still recruiting patients as of now."
Answered by AI
What is the headcount of participants in this clinical study?
"At this time, no further participants are being accepted into the trial first posted on December 15th 2017. However, there are currently 4263 studies looking for patients with pancreatic carcinoma and 764 trials recruiting people receiving VX15/2503 anti-SEMA4D monoclonal antibody treatments."
Answered by AI
What is known about the efficacy of Anti-SEMA4D Monoclonal Antibody VX15/2503 from other research?
"VX15/2503, an anti-SEMA4D monoclonal antibody, was first researched in 2009 at Texas Children's Hospital. Thus far there have been 467 studies completed and 764 recruiting trials are ongoing, with many based out of Rochester New york."
Answered by AI
For what conditions is Anti-SEMA4D Monoclonal Antibody VX15/2503 typically prescribed?
"VX15/2503, an Anti-SEMA4D Monoclonal Antibody is a viable therapeutic option for those with malignant neoplasms that have previously recieved anti-angiogenic therapy and unresectable melanoma."
Answered by AI
Are there any serious risks associated with Anti-SEMA4D Monoclonal Antibody VX15/2503 treatment?
"Our team at Power provided Anti-SEMA4D Monoclonal Antibody VX15/2503 a score of 1, as this is only in Phase 1 trials and thus lacks the data to support its safety and efficacy."
Answered by AI
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