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Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

This study is not yet open for participant recruitment.
Verified September 2017 by Robert R. McWilliams, MD, Hoosier Cancer Research Network
Sponsor:
ClinicalTrials.gov Identifier:
NCT03241186
First Posted: August 7, 2017
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Robert R. McWilliams, MD, Hoosier Cancer Research Network
  Purpose
The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.

Condition Intervention Phase
Mucosal Melanoma Drug: Ipilimumab Drug: Nivolumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Official Title: Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252

Resource links provided by NLM:


Further study details as provided by Robert R. McWilliams, MD, Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Assess Recurrence-free survival time (RFS) [ Time Frame: 1.5 years ]
    Time from registration to documentation of first disease recurrence or death due to any cause.


Secondary Outcome Measures:
  • Assess the Adverse Events [ Time Frame: 2 years ]
    Adverse events will be graded and attribution assigned using CTCAE version 4

  • Overall Survival (OS) [ Time Frame: 2 years ]
    The time from registration to death due to any cause


Estimated Enrollment: 36
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV

Cycles 1-4: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV Day 1 of each Cycle Each Cycle = 21 days

Cycles 5-15: Nivolumab IV 480 mg Day 1 of each Cycle Each Cycle = 28 days

Drug: Ipilimumab
1mg/kg
Other Names:
  • Yervoy
  • BMS-734016
  • MDX010
Drug: Nivolumab
3mg/kg
Other Names:
  • OPDIVO
  • BMS-936558
  • ONO-4538
  • MDX1106
Drug: Nivolumab
480mg
Other Names:
  • OPDIVO
  • BMS-936558
  • ONO-4538
  • MDX1106

Detailed Description:

Ipilimumab and Nivolumab Combination Administration

  • Ipilimumab 1mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles
  • Nivolumab 3mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles

Nivolumab Alone Administration

  • Nivolumab 480mg given IV Day 1 for 4 weeks (28 days), for 5-15 cycles

Nivolumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline.

Ipilimumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline or 5% dextrose solution.

When both study drugs are to be administered on the same day, separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes after completion of the nivolumab infusion.

The dosing calculations should be based on the body weight from Cycle 1 Day 1. If the subject's weight on the day of dosing differs by > 5% from the weight used to calculate the dose, the dose should be recalculated based on the current day of treatment weight. All doses should be rounded to the nearest milligram. There will be no dose modifications allowed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this study:

  • Histological confirmation of melanoma of any mucosal site including (but not limited to) anus/rectum, vulvar/vaginal, sinonasal. NOTE: Melanomas of cutaneous origin and/or ocular origin are ineligible.
  • R0 or R1 resection of primary melanoma tumor (no gross disease can be left behind, but microscopically positive margins are acceptable).
  • Surgery within ≤ 90 days of registration.
  • ECOG Performance Status (PS) ≤ 1

The following laboratory values obtained ≤ 14 days prior to registration:

Hematological:

  • Absolute Neutrophil Count (ANC) ≥ 1500/mm^3
  • Hemoglobin (Hgb) ≥ 9 g/dL (may be transfused)
  • Platelet (Plt) 100,000/mm^3

Renal:

  • Serum Creatinine ≤ 1.5 x ULN

Hepatic:

  • Alkaline Phosphatase (Alk Phos) ≤ 1.5 x upper limit of normal (ULN)
  • Total and Direct Bilirubin ≤ 1.5 × (ULN)
  • Aspartate aminotransferase (AST) ≤ 1.5 × ULN
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Willing to return to enrolling institution for follow-up
  • Willing to provide tissue and/or blood samples for correlative research purposes

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

  • Any of the following because this study involves: an agent that has likely genotoxic, mutagenic, and teratogenic effects:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to use adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Subjects known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Malignancies with a very low (< 5%) risk of recurrence such as non-melanotic skin cancer or carcinoma-in-situ of the cervix.
  • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Active autoimmune disease -including but not limited to:

    • Subjects with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease,
    • Subjects with a history of symptomatic autoimmune disease requiring systemic treatment within the past 2 years with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs.

      • rheumatoid arthritis,
      • systemic progressive sclerosis (scleroderma),
      • systemic lupus erythematosus,
      • psoriasis,
      • autoimmune vasculitis (e.g., Wegener's Granulomatosis),
      • CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain- Barre Syndrome and Myasthenia Gravis, multiple sclerosis).

EXCEPTION: autoimmune conditions that are only requiring 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.

  • Any radiation within 2 weeks prior to study initiation. Neoadjuvant and adjuvant radiation are allowed, but must be completed > 2 weeks prior to registration.
  • Any prior systemic therapy for melanoma (chemotherapy, immunotherapy, targeted therapy)
  • Women of childbearing potential (WOCBP) and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 5 months after the last dose of study drug. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. Examples include: intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, or use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241186


Contacts
Contact: Ahran Lee 317.634.5842 ext 14 alee@hoosiercancer.org
Contact: Robert R. McWilliams, MD 507.284.2511

Sponsors and Collaborators
Robert R. McWilliams, MD
Bristol-Myers Squibb
Hoosier Cancer Research Network
Investigators
Study Chair: Robert R. McWilliams, MD Hoosier Cancer Research Network
  More Information

Additional Information:
Responsible Party: Robert R. McWilliams, MD, Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT03241186     History of Changes
Other Study ID Numbers: MEL16-252
First Submitted: August 2, 2017
First Posted: August 7, 2017
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Robert R. McWilliams, MD, Hoosier Cancer Research Network:
Ipilimumab
Nivolumab
OPDIVO
IgG4 kappa immunoglobulin

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs


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