PhII/IIINivolumab+Ipilimumab+Sargramostim vsNivolumab+Ipilimumab inPts w/UnresecStg IIIorIV Melanoma

UCI Specialty Area: Cancer

Principal Investigator: Warren A Chow

Official Title: Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV Melanoma

A Study On:

Melanoma skin

Study Description

This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.

Eligibility

-Patients must have known BRAF mutational status of tumor; wild-type (WT) or mutated, prior to randomization

-Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for at least one week prior to the start of the research study, and continuing for 5 months for women of childbearing potential and 7 months for sexually active males after the last dose of the study drugs

-Patients must have unresectable stage III or stage IV melanoma; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive

-Adequate organ functions based on lab values

-Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible

-Women must not be pregnant or breast-feeding due to use of cytotoxic immunotherapy and risk of teratogenic side effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

-Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting

-Patients must not receive any other investigational agents while on study or within four weeks prior to randomization

-Patients must not have any serious or unstable pre-existing medical conditions

-Patients with human immunodeficiency virus (HIV) infection are ineligible;

-Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are not eligible; patients with cleared HBV and HCV (0 viral load) infection will be allowed

-Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis); other CNS autoimmune disease (e.g., multiple sclerosis)

-Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)

-Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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