Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

NCT03241186 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MEL16-252
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief Summary

This 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 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.

Conditions

Mucosal Melanoma

Keywords

Ipilimumab; Nivolumab; OPDIVO; IgG4 kappa immunoglobulin

Outcome Measures

Primary Outcomes (1)

• Assess Recurrence-free survival time (RFS)

  Date the patient receives the first dose of study medication to the date of documentation of first disease recurrence or death due to any cause.

  1.5 years

Secondary Outcomes (2)

• Assess the Adverse Events

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV

EXPERIMENTAL

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; Drug: Nivolumab

Interventions

Ipilimumab DRUG

1mg/kg

Also known as: Yervoy, BMS-734016, MDX010

Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV

Nivolumab DRUG

3mg/kg

Also known as: OPDIVO, BMS-936558, ONO-4538, MDX1106

Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Robert R. McWilliams, MD: lead
• Bristol-Myers Squibb: collaborator
• Hoosier Cancer Research Network: collaborator

Study Sites (7)

Mayo Clinic- Florida

Jacksonville, Florida, 32224, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Minnesota

Minneapolis, Minnesota, 555455455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Links

• Hoosier Cancer Research Network Website

MeSH Terms

Interventions

Ipilimumab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robert R. McWilliams, MD

  Hoosier Cancer Research Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: September 12, 2017
• Primary Completion: September 15, 2022
• Study Completion: September 1, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

US (7)