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Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Phase 1NCT03769155

VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma

A Phase 1 study testing Ipilimumab, Nivolumab and VX15/2503 in people with Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, run by Emory University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ipilimumab, Nivolumab and VX15/2503
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
13 Dec 2018to 15 Dec 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Stage IIIB, IIIC, IIID histologically-proven melanoma.
  • Cancer confirmed to be surgically resectable, with surgery evaluation with planned prior to resection.
  • No prior immunotherapy with cytotoxic T-lymphocyte associated protein-4 (CTLA-4), anti programmed cell death-1 (PD-1) or VX15/2503. Prior interferon (at least 1 year prior to consent) will be allowed.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Absolute neutrophil count ≥ 1,500 cells/µL.
  • Platelets ≥ 100,000/µL.
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  • Hemoglobin ≥ 9.0g/dL (may receive packed red blood cells [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 OR calculated creatinine clearance of ≥ 50 mL/min using Cockcroft-Gault formula.
  • International normalized ration (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 (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study treatment and 5 months after last dose of study treatment.
  • Male subjects must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study treatment and 7 months after last dose of study treatment.
  • Female subjects of childbearing age must have a negative serum pregnancy test at study entry.

Who cannot join

  • 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 active or history of immune mediated pneumonitis, colitis, hepatitis, endocrinopathy, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence of their immune mediated disease, potentially delaying surgery.
  • 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.
  • Women who are pregnant or lactating.
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  • 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 (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 non-melanoma skin cancers and 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.
  • Prisoners and subjects who are compulsory detained.
  • Patients with rapidly progressive disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Pilot Integrated Biomarker Study of VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Resectable Metastatic Melanoma

This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed by surgery. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate the effect of VX15/2503 (pepinemab) in combination with immune checkpoint inhibitors on T cell infiltrate into the tumor microenvironment in involved and uninvolved lymph nodes and peripheral blood.

SECONDARY OBJECTIVES:

  1. Evaluate the effect of VX15/2503 in combination with immune checkpoint inhibitors on the immune profile of involved and uninvolved lymph nodes and peripheral blood.

II. Assess safety and tolerability of profile and tolerability of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors in patients with resectable metastatic melanoma.

III. Document pathologic response rates of single agent VX15/2503 and combination VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.

IV. Compare pathologic response to radiographic response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients receiving single agent VX15/2503 and combination VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.

OUTLINE: Participants are assigned to 1 of 5 arms.

ARM I: Participants receive VX15/2503 intravenously (IV) over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

ARM II: Participants receive VX15/2503 IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

ARM III: Participants receive VX15/2503 IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.

ARM IV: Participants nivolumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.

ARM V: Participants undergo surgery.

After completion of study treatment, participants are followed up at 90 days, every 12 weeks for 2 years, every 6 months for 3 years, then annually up to 10 years.

Being tested
Ipilimumab, Nivolumab, VX15/2503, Surgery

What participants receive

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

  • IpilimumabBiological

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

    Given IV

  • NivolumabBiological

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

    Given IV

  • VX15/2503Biological

    Also called moAb VX15/2503, Pepinemab

    Given IV

  • SurgeryProcedure or surgery

    Undergo therapeutic conventional surgery

Study groups in NCT03769155
Study groupRoleWhat they receive
A (VX15/2503, nivolumab, surgery)ExperimentalParticipants receive VX15/2503 (pepinemab) IV over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.
Receives: Biological: Nivolumab; Biological: VX15/2503; Procedure: Surgery
B (VX15/2503, ipilimumab, surgery)ExperimentalParticipants receive VX15/2503 (pepinemab) IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.
Receives: Biological: Ipilimumab; Biological: VX15/2503; Procedure: Surgery
C (VX15/2503, nivolumab, ipilimumab, surgery)ExperimentalParticipants receive VX15/2503 (pepinemab) IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.
Receives: Biological: Ipilimumab; Biological: Nivolumab; Biological: VX15/2503; Procedure: Surgery
D (nivolumab, surgery)ExperimentalParticipants receive nivolumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.
Receives: Biological: Nivolumab; Procedure: Surgery
E (surgery)Active comparatorParticipants undergo surgery.
Receives: Procedure: Surgery

What is being measured

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

  1. Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment

    The two-sample t-test will be used to compare the change in CD8+ T cell infiltration after treatment between each experimental group (Cohort A, B, C, and D) and the control group (cohort E), respectively.

    Measured: Up to 10 years after study start

Secondary outcomes (4)

  1. Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Descriptive statistics for worst grade of each laboratory parameter by the NCI CTCAE scale version 4.0 at baseline and follow-up will be presented.

    Measured: Up to 8 weeks after surgery

  2. Response rate

    For participants to be considered evaluable for efficacy, they must have completed the treatment and have a baseline tumor assessment. Response rate will be calculated as proportion (responders/total participants).

    Measured: Up to 10 years after study start

  3. Overall survival (OS)

    For overall survival, death from any cause will be defined as the event.

    Measured: Assessed up to 10 years after study start

  4. Progression-free survival (PFS)

    Progression or death from any cause will be defined as the event.

    Measured: Assessed up to 10 years after study start

Timeline

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

  1. First posted7 Dec 2018
  2. Study start13 Dec 2018
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2032 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03769155
Sponsor's protocol ID
IRB00104273
Other IDs
NCI-2018-01229, Winship4400-18, P30CA138292
Status last verified
Apr 2026
First submitted
6 Dec 2018
Last updated
5 May 2026
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 Ipilimumab, Nivolumab and VX15/2503 in people with Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, run by Emory University 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 17 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment (time frame: Up to 10 years after study start). 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 NCT03769155.

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 5 May 2026.

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