A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 12, 2015
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness and side effects of two immunotherapy drugs, nivolumab and ipilimumab, either alone or combined with another drug called sargramostim, for patients with advanced melanoma that cannot be surgically removed. The goal is to see how well these treatments can help the immune system fight the cancer. Patients eligible for this trial must be at least 18 years old, have a specific type of advanced melanoma, and meet certain health criteria.
Participants can expect to receive regular treatment and monitoring throughout the study. They will need to follow specific guidelines, such as using effective birth control if they can become pregnant and avoiding certain medications and vaccines during the trial. It’s important for candidates to have their melanoma confirmed and to not have other serious health conditions that could complicate their treatment. This trial is currently recruiting participants, and it aims to provide valuable information about how these treatments can work together against melanoma.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • All patients must be \>= 18 years of age
- • Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
- • Patients must have known BRAF mutational status of tumor; wild-type (WT) or mutated, prior to randomization
- • Patients must not be pregnant or breast-feeding due to use of cytotoxic immunotherapy and risk of teratogenic side effects; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a patient of childbearing potential is anyone, 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 must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing (for patients of child bearing potential) for at least 5 months after the last dose of protocol treatment; patients of childbearing potential must also not donate eggs during this same time period
- • Patients must have unresectable stage III or stage IV melanoma according to American Joint Committee on Cancer (AJCC) version (v)7; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
- • Patients must have measurable disease per RECIST 1.1 criteria; all sites of disease must be evaluated within 4 weeks prior to randomization
- • Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or MEK agents). Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment. Patients may have had any prior anti-PD-1 or anti-PD-L1 agent in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment
- • Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting
- • Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting \>= 4 weeks prior to randomization and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy \>= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be \>= 4 weeks from randomization and patients must be fully recovered from post-surgical complications
- • Patients must not receive any other investigational agents while on study or within four weeks prior to randomization
- • Patient must not have received any live vaccine within 30 days prior to randomization, while participating in the study, and for 4 weeks (28 days) after the last dose of protocol treatment; live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 19 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist (registered trademark) are live attenuated vaccines and are not allowed); if possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
- • Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks prior to randomization are eligible; patients must not have taken any steroids =\< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible
- • Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for \> 3 years prior to the time of randomization
- • White blood count \>= 3,000/uL (obtained within 4 weeks prior to randomization)
- • Absolute neutrophil count (ANC) \>= 1,500/uL (obtained within 4 weeks prior to randomization)
- • Platelet count \>= 100,000/uL (obtained within 4 weeks prior to randomization)
- • Hemoglobin \>= 9 g/dL (obtained within 4 weeks prior to randomization)
- • Serum creatinine =\< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) \>= 40 ml/min (obtained within 4 weeks prior to randomization)
- • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (=\< 5 x ULN for patients with documented liver metastases) (obtained within 4 weeks prior to randomization)
- • Alkaline phosphatase =\< 2 x ULN (=\< 5 x ULN for patients with known liver involvement and =\< 7 x ULN for patients with known bone involvement) (obtained within 4 weeks prior to randomization)
- • Total bilirubin =\< 1.5 x ULN except patients with normal direct bilirubin; those patients with known Gilbert's syndrome must have total bilirubin \< 3 x ULN (obtained within 4 weeks prior to randomization)
- • Serum lactate dehydrogenase (LDH) =\< 10 X ULN (obtained within 4 weeks prior to randomization)
- • Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio \[INR\] =\< 1.5 and partial thromboplastin time \[PTT\] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with patient's safety, or obtaining informed consent
- • Patients with human immunodeficiency virus (HIV) infection are ineligible; due to the mechanism of action of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient are unknown
- • 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
- • Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study
- • 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 with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
- • 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 that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
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Richlands, North Carolina, United States
Greenville, South Carolina, United States
Eau Claire, Wisconsin, United States
Council Bluffs, Iowa, United States
Honolulu, Hawaii, United States
Fremont, California, United States
Farmington, Utah, United States
Port Townsend, Washington, United States
Milwaukee, Wisconsin, United States
'Aiea, Hawaii, United States
Kenner, Louisiana, United States
Mukwonago, Wisconsin, United States
'Aiea, Hawaii, United States
Waukesha, Wisconsin, United States
Ontario, California, United States
Overland Park, Kansas, United States
Westwood, Kansas, United States
Ashland, Wisconsin, United States
Hendersonville, North Carolina, United States
Selinsgrove, Pennsylvania, United States
Westlake, Ohio, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
North Kansas City, Missouri, United States
Boulder, Colorado, United States
Covington, Louisiana, United States
Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Rio Rancho, New Mexico, United States
Perrysburg, Ohio, United States
Buffalo, New York, United States
Brewer, Maine, United States
Sacramento, California, United States
Miami, Florida, United States
Guilford, Connecticut, United States
Waterbury, Connecticut, United States
Waterford, Connecticut, United States
Dekalb, Illinois, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Beavercreek, Ohio, United States
Stevens Point, Wisconsin, United States
Winchester, Virginia, United States
New Haven, Connecticut, United States
Baton Rouge, Louisiana, United States
Aitkin, Minnesota, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Hazleton, Pennsylvania, United States
Bluffton, South Carolina, United States
Hilton Head Island, South Carolina, United States
Ashland, Wisconsin, United States
Medford, Wisconsin, United States
Honolulu, Hawaii, United States
Rice Lake, Wisconsin, United States
Plantation, Florida, United States
Honolulu, Hawaii, United States
Mooresville, Indiana, United States
Worthington, Minnesota, United States
Easton, Pennsylvania, United States
'Aiea, Hawaii, United States
Lake Forest, Illinois, United States
Detroit Lakes, Minnesota, United States
Fosston, Minnesota, United States
Park Rapids, Minnesota, United States
Jamestown, North Dakota, United States
Oak Ridge, Tennessee, United States
Brighton, Michigan, United States
Mechanicsburg, Pennsylvania, United States
Tampa, Florida, United States
Springfield, Ohio, United States
Fargo, North Dakota, United States
Libertyville, Illinois, United States
Kingman, Arizona, United States
Englewood, Colorado, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Baton Rouge, Louisiana, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
San Mateo, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Tampa, Florida, United States
Burnsville, Minnesota, United States
Aventura, Florida, United States
Bozeman, Montana, United States
Baton Rouge, Louisiana, United States
Duluth, Georgia, United States
Kennebunk, Maine, United States
Alma, Michigan, United States
Alpena, Michigan, United States
Gladwin, Michigan, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Savannah, Georgia, United States
'Aiea, Hawaii, United States
'Ewa Beach, Hawaii, United States
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Kalamazoo, Michigan, United States
Baxter, Minnesota, United States
Ely, Minnesota, United States
International Falls, Minnesota, United States
Moose Lake, Minnesota, United States
Thief River Falls, Minnesota, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Dublin, Ohio, United States
Indiana, Pennsylvania, United States
Washington, Pennsylvania, United States
Cudahy, Wisconsin, United States
Maryville, Tennessee, United States
Rochester, New York, United States
Glastonbury, Connecticut, United States
Westerly, Rhode Island, United States
Little Rock, Arkansas, United States
Greeley, Colorado, United States
'Aiea, Hawaii, United States
Springfield, Illinois, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Pekin, Illinois, United States
Kansas City, Missouri, United States
Avon, Ohio, United States
Cumberland, Maryland, United States
Allentown, Pennsylvania, United States
Kalispell, Montana, United States
Lebanon, New Hampshire, United States
Moon, Pennsylvania, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Grove City, Ohio, United States
Pontiac, Michigan, United States
Pittsburg, Kansas, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Dayton, Ohio, United States
Mount Pleasant, Michigan, United States
Danville, Illinois, United States
New Albany, Ohio, United States
Guilford, Connecticut, United States
Orland Park, Illinois, United States
Quakertown, Pennsylvania, United States
Greenville, Ohio, United States
Decatur, Georgia, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Oak Lawn, Illinois, United States
Palos Heights, Illinois, United States
Stroudsburg, Pennsylvania, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Reed City, Michigan, United States
O'fallon, Illinois, United States
Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Loveland, Colorado, United States
Hays, Kansas, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Council Bluffs, Iowa, United States
Madison, Wisconsin, United States
Kinston, North Carolina, United States
Lynchburg, Virginia, United States
Wilmington, Ohio, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Johnson Creek, Wisconsin, United States
Royal Oak, Michigan, United States
Johnson Creek, Wisconsin, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Kenansville, North Carolina, United States
Richlands, North Carolina, United States
Irvine, California, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Santa Cruz, California, United States
Wheat Ridge, Colorado, United States
Southfield, Michigan, United States
Madison, Wisconsin, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Aurora, Illinois, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Warren, Michigan, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Harbor City, California, United States
Havre, Montana, United States
Denver, Colorado, United States
Olathe, Kansas, United States
Grosse Pointe Woods, Michigan, United States
Rochester Hills, Michigan, United States
Paramus, New Jersey, United States
Paramus, New Jersey, United States
Denver, Colorado, United States
Westbook, Maine, United States
Parker, Colorado, United States
Cape Girardeau, Missouri, United States
Westbrook, Maine, United States
Crosslake, Minnesota, United States
Pequot Lakes, Minnesota, United States
Pine River, Minnesota, United States
Staples, Minnesota, United States
Hayward, Wisconsin, United States
Patients applied
Trial Officials
Frank S Hodi
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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