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Melanoma (Skin)Phase 2NCT03405155

Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery

A Phase 2 study testing Nivolumab in people with Melanoma (Skin), run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson 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 phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC melanoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
4 sitesUnited States
Study dates
17 Jan 2018to 15 Dec 2025
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

  • Patients must have completely resected (as per standard of care) melanoma of cutaneous origin in order to be eligible for this study; patients must be classified as stage IIB or IIC cutaneous melanoma using the American Joint Committee on Cancer eighth edition; patients with melanoma of mucosal or other non-cutaneous origin are not eligible; patients with melanoma of ocular origin are not eligible
  • Patients must have a negative sentinel lymph node biopsy or undergo a failed attempt at sentinel lymph node biopsy including lymphoscintography which fails to show a sentinel lymph node from the melanoma primary site
  • Patients must have systemic cross-sectional imaging (positron emission tomography [PET]/computed tomography [CT] or CT of chest, abdomen, and pelvis) which shows no evidence of metastatic disease
  • Patient must be able to comprehend and sign a written informed consent and be willing to comply with all study procedures
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count (ANC) >= 1,500 microliter (mcL)
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  • Platelets >= 100,000/mcL
  • Hemoglobin >= 10 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and alkaline phosphatase =< 2 x institutional upper limit of normal (IULN)
  • Serum creatinine =< 1.5xULN OR measured or calculated creatinine clearance >= 60 mL/min
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate CD4 counts (>= 350 mm^3), and serum HIV viral load of < 25,000 IU/ml; patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; 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; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing
  • Therapy must be initiated within 120 days of surgical resection of the sentinel lymph nodes and within 6 months of initial diagnosis.
  • Patients must be willing to have archived tumor specimens utilized for correlative studies if available
  • Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration

Who cannot join

  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
  • Current immunosuppressive therapy including > 10 mg/day of prednisone within 14 days of enrollment is not permitted; inhaled or topical steroids, and adrenal replacement steroid doses =< 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Patients must not have received live vaccines within 42 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
  • Patients must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the trial results, interfere with the patient's participation for the full duration of the trial, or indicate that participation in the trial is not in the patient's best interests, in the opinion of the treating investigator
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  • Patients must not be pregnant or lactating
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) is not permitted
  • Treatment with any investigational agent within 14 days of first administration of study treatment is not permitted

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Columbia University

    New York, New York, 10032

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Phase II Study of Adjuvant Nivolumab in Patients With Resected Stage IIB/IIC Melanoma

This phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC melanoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the efficacy nivolumab administered in the adjuvant setting in patients with resected stage IIB or stage IIC cutaneous melanoma.

SECONDARY OBJECTIVES:

  1. To evaluate and estimate the median duration of overall survival (OS) in stage IIB-IIC melanoma patients.

II. To evaluate and estimate the median duration of distant metastases-free survival (DMFS) in stage IIB-IIC melanoma patients.

III. To assess safety and toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version (V)5.

IV. To assess quality of life using the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life instrument.

TERTIARY OBJECTIVES:

  1. To assess and compare clinical, histological, immunological and molecular panels as prognostic and predictive biomarkers.
Conditions
Melanoma (Skin)
Being tested
Nivolumab
Medical subject headings
Melanoma

What participants receive

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

  • NivolumabBiological

    Also called BMS-936558, NIVO, Opdivo, ONO-4538

    Given IV

Study groups in NCT03405155
Study groupRoleWhat they receive
Treatment (nivolumab)ExperimentalPatients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Nivolumab

What is being measured

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

  1. Recurrence-free Survival

    Kaplan-Meier estimate of the percentage of participants who were recurrence-free at approximately 2 years after treatment initiation.

    Measured: Approximately 22 months (2 years)

Secondary outcomes (3)

  1. Overall Survival

    Overall Survival (OS) is defined as time from study entry until death from any cause. OS will be determined, as will the cumulative percentage of patients remaining progression-free/alive at selected time points after initial treatment at 24 months

    Measured: Up to 24 months

  2. Cumulative Percentage of Patients Remaining Distant Metastases-Free/Alive at 1yr and 2yrs After Initial Treatment

    The cumulative percentage of patients remaining distant metastases-free/alive at 1yr and 2yrs after initial treatment

    Measured: Up to 24 months

  3. Number of Adverse Events

    Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Up to 24 months

Timeline

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

  1. First posted19 Jan 2018
  2. Study start17 Jan 2018
  3. Primary completion15 Dec 2025
  4. Study completion15 Dec 2025

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03405155
Sponsor's protocol ID
17P.641
Other IDs
JT 11821
Status last verified
Jun 2026
First submitted
12 Jan 2018
Last updated
16 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Melanoma (Skin), run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson 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 16 inclusion and 9 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 16 Jul 2026. 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 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 16 Jun 2026). 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?

Recurrence-free Survival (time frame: Approximately 22 months (2 years)). 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 NCT03405155.

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 16 Jul 2026.

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