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MelanomaPhase 2NCT02970981

Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma

A Phase 2 study testing Nivolumab and Ipilimumab in people with Melanoma, run by NYU Langone Health at 1 site 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

The purpose of this study is to assess the safety and tolerability of treatment with Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV melanoma. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Melanoma
What is being tested?
Nivolumab and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
29 Nov 2016to 2 May 2022
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Be at least 16 years of age;
  • Histologic diagnosis of resected Stages IIIB/IIIC/ IV melanoma, with no evidence of disease clinically and radiologically, and negative surgical margins. All melanomas regardless of primary site of disease will be allowed;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) must have been completed at least 4 weeks before study drug administration, and all adverse events have either returned to baseline or stabilized;
  • Prior treated brain or meningeal metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration;
  • Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration. Prior focal radiotherapy completed at least 2 weeks before study drug administration. No radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration;
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  • Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration;
  • Completed nitrosourea treatment at least 6 weeks before administration of any study drug;
  • Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration and subjects should be recovered;
  • Screening laboratory values must meet the following criteria:
  • white blood cells (WBCs) ≥ 2000 cells/μL
  • neutrophils ≥ 1500 cells/μL
  • platelets ≥ 100 x 103/μL
  • hemoglobin ≥ 9.0 g/dL
  • serum creatinine ≤ 2 mg/dL
  • AST ≤ 2.5 x upper limit of normal (ULN) without, and ≤ 5 x ULN with hepatic metastasis
  • ALT ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis
  • bilirubin ≤ 2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
  • Females of childbearing potential must:
  • use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab.
  • For female subjects to be considered as not having childbearing potential, they must meet 1 or more of the following criteria:
  • postmenopausal for at least 24 consecutive months;
  • surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy);
  • females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > 35 mIU/mL;
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
  • Subject must have read, understood, and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained; and
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Who cannot join

  • Subjects who fulfill any of the following conditions at Screening will not be eligible for admission into the study:
  • History of severe hypersensitivity reactions to other mAbs;
  • Prior non-melanoma malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast;
  • Subjects with any active autoimmune disease (Appendix 3) or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy;
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
  • Positive tests for hepatitis B virus surface antigen (HBV SAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection;
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  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways);
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
  • Underlying medical condition (eg, a condition associated with diarrhea) that, in the Investigator's opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse events;
  • Pregnant or nursing; or
  • Current participation in another clinical study involving treatment with medications, radiation or surgery, or prior participation in this study.
  • Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for [lowest minimum is 4 weeks or more] after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
  • As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen.
  • Allergies and Adverse Drug Reaction
  • History of allergy to study drug components
  • History of severe hypersensitivity reaction to any monoclonal antibody

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

Other trials in United States

About this study

Official title: A Pilot Trial of Ipilimumab With Nivolumab for Participants With Resected Stages IIIB/IIIC/ IV Melanoma

The purpose of this study is to assess the safety and tolerability of treatment with Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV melanoma.

Read the detailed description

The investigators hypothesize that PD-1 blockade combined with CTLA-4 blockade using ipilimumab would have a favorable effect on the expansion and activity of human CD8+ T cytotoxic lymphocytes (CTLs) specific for tumor-associated antigens (ie, self antigens), which would translate into improved anti-cancer therapy.

Conditions
Melanoma
Being tested
Nivolumab, Ipilimumab
Keywords
Monoclonal antibody, Programmed Death-1 (PD-1), Programmed Death-Ligand 1 (PD-L1), Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), Antigen
Medical subject headings
Melanoma, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

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

  • NivolumabBiological

    Also called Opdivo, NSC 748726

  • IpilimumabBiological

    Also called Yervoy, NSC 732442

Study groups in NCT02970981
Study groupRoleWhat they receive
Nivolumab and IpilimumabExperimentalDosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1) Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Receives: Biological: Nivolumab; Biological: Ipilimumab

What is being measured

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

  1. Relapse-Free Survival

    Number of participants who are relapse-free at 48 months after initiating treatment in the study.

    Measured: Month 48 Post-Treatment Initiation

Secondary outcomes (2)

  1. Number of Cases of Adverse Events Occurring During Study

    The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) V4.

    Measured: Month 12 Post-Treatment Initiation

  2. Overall Survival

    Percentage of participants who are alive at at 48 months after initiating treatment in the study.

    Measured: Month 48 Post-Treatment Initiation

Timeline

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

  1. First posted22 Nov 2016 (estimated)
  2. Study start29 Nov 2016
  3. Primary completionNov 2018
  4. Study completion2 May 2022

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02970981
Sponsor's protocol ID
16-00098
Status last verified
Apr 2024
First submitted
18 Nov 2016
Last updated
30 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Khushalani NI, Vassallo M, Goldberg JD, Eroglu Z, Kim Y, Cao B, Ferguson R, Monson KR, Kirchhoff T, Amato CM, Burke P, Strange A, Monk E, Gibney GT, Kudchadkar R, Markowitz J, Brohl AS, Pavlick A, Richards A, Woods DM, Weber J. Phase II clinical and immune correlate study of adjuvant nivolumab plus ipilimumab for high-risk resected melanoma. J Immunother Cancer. 2022 Nov;10(11):e005684. doi: 10.1136/jitc-2022-005684.

    PubMed 36450385

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Melanoma, run by NYU Langone Health 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 28 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: finished, as of the sponsor's last update on 30 Apr 2024. 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 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 11 Mar 2020). 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?

Relapse-Free Survival (time frame: Month 48 Post-Treatment Initiation). 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 NCT02970981, which also lists 1 linked publication.

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 30 Apr 2024.

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