What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, including monoclonal antibodies and immunotherapies like Anti-SEMA4D, ipilimumab, and nivolumab, often result in side effects such as fatigue, rash, diarrhea, and immune-related adverse events like pneumonitis and colitis. Chemotherapy regimens, such as gemcitabine combined with nab-paclitaxel, frequently cause neutropenia, neuropathy, fatigue, and gastrointestinal issues like nausea and diarrhea. These side effects vary in severity and frequency, necessitating close monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and combination regimens such as FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin). Immunotherapy options include pembrolizumab, a PD-1 inhibitor, which has been approved for tumors with specific genetic markers (MSI-H or dMMR). While there is limited information on FDA approvals for treatments specifically targeting SEMA4D, the use of monoclonal antibodies and immune checkpoint inhibitors represents a growing area of interest in pancreatic cancer treatment.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Immunotherapy agents such as pembrolizumab and nivolumab, which are being investigated for their efficacy in combination with other treatments. 2) Targeted therapies like PARP inhibitors (e.g., olaparib) for patients with BRCA mutations. 3) Combination therapies involving checkpoint inhibitors and other agents, such as pembrolizumab plus cetuximab. 4) Investigational drugs targeting specific molecular pathways involved in pancreatic cancer progression.

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Monoclonal Antibodies

VX15/2503 + Immunotherapy for Pancreatic and Colorectal Cancer

Phase 1

Waitlist Available

Led By Christina Wu, 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

Must not have

Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment

Determined not to be a surgical candidate due to medical co-morbidities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years from date of last treatment dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine that blocks a protein helping cancer grow, with or without additional medicines that boost the immune system. It targets patients with certain types of pancreatic or colorectal cancer that can be surgically removed.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had serious infections needing treatment in the last week.

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I cannot have surgery because of other health problems.

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I have had an organ or bone marrow transplant from another person.

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I am not pregnant or breastfeeding.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have a bleeding disorder or a condition affecting blood clotting.

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I haven't taken any experimental drugs recently.

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I am on long-term immunosuppressants like cyclosporine.

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I have been cancer-free for over 5 years, or had a cancer that was completely removed.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years from date of last treatment dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate treatment effects of the study drugs on tumor cluster of differentiation 8+ (CD8+) T cell infiltration between the treatment groups.

Secondary study objectives

Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events scale version 4.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2490

Anti-SEMA4D Monoclonal Antibody VX15/2503

2017

Completed Phase 1

~10

Ipilimumab

2015

Completed Phase 3

~3070

Nivolumab

2015

Completed Phase 3

~4010

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include immune checkpoint inhibitors and monoclonal antibodies. Immune checkpoint inhibitors, such as pembrolizumab, target proteins like PD-1 to enhance the immune system's ability to attack cancer cells. Monoclonal antibodies, such as Anti-SEMA4D Monoclonal Antibody VX15/2503, inhibit specific molecules like SEMA4D to prevent tumor growth and spread. These treatments are significant for pancreatic cancer patients as they offer targeted approaches that can potentially improve outcomes by directly interfering with cancer cell mechanisms and enhancing the body's immune response against the tumor.