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Colon Carcinoma Metastatic in the LiverPhase 1NCT03373188

VX15/2503 and Immunotherapy in Resectable Pancreatic and Colorectal Cancer

A Phase 1 study testing Anti-SEMA4D Monoclonal Antibody VX15/2503, Ipilimumab and Nivolumab in people with Colon Carcinoma Metastatic in the Liver and Colorectal Adenocarcinoma, run by Emory University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anti-SEMA4D Monoclonal Antibody VX15/2503, Ipilimumab and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesUnited States
Study dates
15 Dec 2017to 28 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

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

  • For patients with pancreatic cancer:
  • Stage I-III cytologically or histologically-proven pancreatic adenocarcinoma
  • Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection
  • Patients may have prior neoadjuvant chemotherapy, but no neoadjuvant chemoradiation
  • No cancer chemotherapy treatment 2 weeks prior to day 2 of treatment
  • For patients with metastatic colorectal cancer:
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  • Stage IV histologically-proven colorectal adenocarcinoma
  • Liver metastasis confirmed to be surgically resectable, with surgery evaluation and planned resection; may have minimal extrahepatic disease that is determined to be resectable
  • 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
  • No prior immunotherapy
  • No cancer chemotherapy treatment 2 weeks prior to day 1 of treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count ≥ 1,500 cells/µL
  • Platelets ≥ 100,000/µL
  • Hemoglobin ≥ 9.0 g/dL (may receive packed red blood cell [prbc] transfusion)
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Albumin ≥ 3.0 g/dL
  • Serum creatinine ≤ 1.5 x ULN
  • Calculated creatinine clearance of ≥ 50 mL/min
  • International normalized ratio (INR) ≤ 1.5; anticoagulation is allowed only with low molecular weight heparin (LMWH); patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1 U/mL are allowed on the trial
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Ability to understand and willingness to sign a written informed consent document
  • Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
  • Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
  • Female subjects of childbearing age must have a negative serum pregnancy test at study entry

Who cannot join

  • Poor venous access for study drug administration
  • Determined not to be a surgical candidate due to medical co-morbidities
  • Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
  • Prior organ allograft or allogeneic bone marrow transplantation
  • Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
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  • Women who are pregnant or lactating
  • Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
  • Clinical evidence of bleeding diathesis or coagulopathy
  • Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for > 5 years; patients with prior in situ carcinomas are eligible provided there was complete removal
  • Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
  • Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Phase I Integrated Biomarker Trial of VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Pancreatic and Colorectal Cancer

This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVE:

To evaluate the effect of the anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) alone and VX15/2503 in combination with immune checkpoint inhibitors, ipilimumab or nivolumab, on the immune profile in the tumor microenvironment and in peripheral blood.

SECONDARY OBJECTIVE:

To extend the previously reported safety profile of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors, ipilimumab or nivolumab, in patients with pancreatic and colorectal cancer.

OUTLINE:

Patients are randomized to 1 of 4 arms.

ARM I: Patients undergo surgery.

ARM II: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 intravenously (IV) over 60 minutes on day 1. Patients then proceed to surgery 22-36 days after drug administration.

ARM III: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Patients then proceed to surgery 22-36 days after drug administration.

ARM IV: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and nivolumab IV over 60 minutes on day 1. Patients then proceed to surgery 22-36 days after drug administration.

After completion of study treatment, patients are followed up at 90 days and then every 12 weeks thereafter.

Being tested
Anti-SEMA4D Monoclonal Antibody VX15/2503, Ipilimumab, Nivolumab, Surgery
Medical subject headings
Pancreatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-SEMA4D Monoclonal Antibody VX15/2503Biological

    Also called moAb VX15/2503, VX15/2503

    Given IV

  • IpilimumabBiological

    Also called BMS-734016, MDX-010, MDX-CTLA4, Yervoy

    Given IV

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, NIVO, ONO-4538

    Given IV

  • SurgeryProcedure or surgery

    Undergo therapeutic conventional surgery

Study groups in NCT03373188
Study groupRoleWhat they receive
Arm I (surgery)Active comparatorPatients undergo surgery.
Receives: Procedure: Surgery
Arm II (VX15/2503, surgery)ExperimentalPatients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.
Receives: Biological: Anti-SEMA4D Monoclonal Antibody VX15/2503; Procedure: Surgery
Arm III (VX15/2503, ipilimumab, surgery)ExperimentalPatients 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.
Receives: Biological: Anti-SEMA4D Monoclonal Antibody VX15/2503; Biological: Ipilimumab; Procedure: Surgery
Arm IV (VX15/2503, nivolumab, surgery)ExperimentalPatients 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.
Receives: Biological: Anti-SEMA4D Monoclonal Antibody VX15/2503; Biological: Nivolumab; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    CD8+ T cells in tumor samples will be identified by immunohistochemistry and immunofluorescence staining, and we will quantitate the percentage and staining of the cells in the pancreatic and liver tissue with Integrated Cellular Imaging.

    Measured: Up to 4 years from date of last treatment dose

Secondary outcomes (1)

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

    Summary statistics will be presented for all safety analyses. Toxicities will be presented as worst toxicity per patient and will be reported as percent toxicity. Adverse events will be classified using MedDRA System Organ Classes and Preferred Terms.

    Measured: Up to 4 years from the date of last treatment dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study start15 Dec 2017
  3. Primary completion28 Oct 2021
  4. Study completion28 Oct 2021

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373188
Sponsor's protocol ID
IRB00098707
Other IDs
NCI-2017-01618, Winship4142-17, P30CA138292
Status last verified
Mar 2024
First submitted
11 Dec 2017
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-SEMA4D Monoclonal Antibody VX15/2503, Ipilimumab and Nivolumab in people with Colon Carcinoma Metastatic in the Liver and Colorectal Adenocarcinoma, run by Emory University at 4 sites 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 26 inclusion and 15 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate treatment effects of the study drugs on tumor cluster of differentiation 8+ (CD8+) T cell infiltration between the treatment groups. (time frame: Up to 4 years from date of last treatment dose). 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 NCT03373188.

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 20 Mar 2024.

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