Last updated on November 2019

Ipilimumab With or Without Nivolumab in Treating Patients With Melanoma That Is Stage IV or Stage III and Cannot Be Removed by Surgery


Brief description of study

This phase II trial studies how well ipilimumab with or without nivolumab work in treating patients with melanoma that is stage IV or stage III and cannot be removed by surgery. 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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare progression free survival (PFS) of patients with advanced melanoma refractory to an anti-PD-1 or anti-PD-L1 agent, treated with combination therapy ipilimumab plus nivolumab versus ipilimumab alone.

SECONDARY OBJECTIVES:

I. To estimate difference in T-cell infiltrate between on-study biopsy samples of patients who respond to combination therapy (including confirmed and unconfirmed, complete and partial response per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1, in each treatment arm).

II. To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, in each treatment arm.

III. To evaluate the overall survival (OS) of patients in each treatment arm. IV. To evaluate the toxicity profile of patients in each treatment arm.

TRANSITIONAL OBJECTIVES:

I. To assess the marginal prognostic value of baseline T-cell density, T-cell receptor (TCR) clonality, mutational load, and messenger ribonucleic acid (mRNA) expression levels in terms of response.

II. To assess the joint prognostic value of T-cell density, TCR clonality, and mutational load, and mRNA expression levels in terms of response.

III. To identify T-cell poor subtype(s) that are associated with response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 1 year.

Clinical Study Identifier: NCT03033576

Find a site near you

Start Over

Bay Area Tumor Institute

Oakland, CA United States
  Connect »

Mercy Hospital

Coon Rapids, MN United States
  Connect »

Kootenai Cancer Center

Post Falls, ID United States
  Connect »

Katmai Oncology Group

Anchorage, AK United States
  Connect »

Mercy Hospital Springfield

Springfield, MO United States
  Connect »

Mercy Hospital Joplin

Joplin, MO United States
  Connect »

Epic Care Cyberknife Center

Walnut Creek, CA United States
  Connect »

Island Urology

Honolulu, HI United States
  Connect »

Boulder Community Hospital

Boulder, CO United States
  Connect »

Adena Regional Medical Center

Chillicothe, OH United States
  Connect »

Peninsula Cancer Center

Poulsbo, WA United States
  Connect »

Mercy Health Saint Mary's

Grand Rapids, MI United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Rapid City Regional Hospital

Rapid City, SD United States
  Connect »

Olathe Medical Center

Olathe, KS United States
  Connect »

Saint Francis Cancer Center

Greenville, SC United States
  Connect »

Physicians' Clinic of Iowa PC

Cedar Rapids, IA United States
  Connect »

Heartland Regional Medical Center

Saint Joseph, MO United States
  Connect »

Northwest Cancer Clinic

Kennewick, WA United States
  Connect »

Kaiser Permanente-Oakland

Oakland, CA United States
  Connect »

Valley Medical Center

Renton, WA United States
  Connect »

Freeman Health System

Joplin, MO United States
  Connect »

Fairbanks Memorial Hospital

Fairbanks, AK United States
  Connect »

Marshfield Clinic-Chippewa Center

Chippewa Falls, WI United States
  Connect »

PCR Oncology

Arroyo Grande, CA United States
  Connect »

Bay Area Hospital

Coos Bay, OR United States
  Connect »

Mills-Peninsula Medical Center

Burlingame, CA United States
  Connect »

Reid Health

Richmond, IN United States
  Connect »

Alaska Women's Cancer Care

Anchorage, AK United States
  Connect »

Anchorage Oncology Centre

Anchorage, AK United States
  Connect »

Eden Hospital Medical Center

Castro Valley, CA United States
  Connect »

Sutter Davis Hospital

Davis, CA United States
  Connect »

Kaiser Permanente-Fremont

Fremont, CA United States
  Connect »

Fresno Cancer Center

Fresno, CA United States
  Connect »

Kaiser Permanente-Fresno

Fresno, CA United States
  Connect »

City of Hope Antelope Valley

Lancaster, CA United States
  Connect »

Memorial Medical Center

Modesto, CA United States
  Connect »

Kaiser Permanente-Modesto

Modesto, CA United States
  Connect »

City of Hope Rancho Cucamonga

Rancho Cucamonga, CA United States
  Connect »

Kaiser Permanente-Redwood City

Redwood City, CA United States
  Connect »

Kaiser Permanente-Richmond

Richmond, CA United States
  Connect »

Rohnert Park Cancer Center

Rohnert Park, CA United States
  Connect »

Kaiser Permanente-Roseville

Roseville, CA United States
  Connect »

South Sacramento Cancer Center

Sacramento, CA United States
  Connect »

Kaiser Permanente - Sacramento

Sacramento, CA United States
  Connect »

Kaiser Permanente-San Francisco

San Francisco, CA United States
  Connect »

Kaiser Permanente San Leandro

San Leandro, CA United States
  Connect »

Kaiser Permanente-San Rafael

San Rafael, CA United States
  Connect »

Kaiser San Rafael-Gallinas

San Rafael, CA United States
  Connect »

Kaiser Permanente-Santa Rosa

Santa Rosa, CA United States
  Connect »

City of Hope South Pasadena

South Pasadena, CA United States
  Connect »

Kaiser Permanente Cancer Treatment Center

South San Francisco, CA United States
  Connect »

Kaiser Permanente-South San Francisco

South San Francisco, CA United States
  Connect »

Kaiser Permanente-Stockton

Stockton, CA United States
  Connect »

Kaiser Permanente-Vallejo

Vallejo, CA United States
  Connect »

Kaiser Permanente-Walnut Creek

Walnut Creek, CA United States
  Connect »

Penrose-Saint Francis Healthcare

Colorado Springs, CO United States
  Connect »

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, CO United States
  Connect »

Porter Adventist Hospital

Denver, CO United States
  Connect »

Mercy Medical Center

Durango, CO United States
  Connect »

Southwest Oncology PC

Durango, CO United States
  Connect »

Swedish Medical Center

Englewood, CO United States
  Connect »

UCHealth Greeley Hospital

Greeley, CO United States
  Connect »

Saint Anthony Hospital

Lakewood, CO United States
  Connect »

Littleton Adventist Hospital

Littleton, CO United States
  Connect »

Longmont United Hospital

Longmont, CO United States
  Connect »

McKee Medical Center

Loveland, CO United States
  Connect »

Parker Adventist Hospital

Parker, CO United States
  Connect »

Mount Sinai Medical Center

Miami Beach, FL United States
  Connect »

Moffitt Cancer Center

Tampa, FL United States
  Connect »

Queen's Medical Center

Honolulu, HI United States
  Connect »

Kootenai Medical Center

Coeur d'Alene, ID United States
  Connect »

Kootenai Cancer Clinic

Sandpoint, ID United States
  Connect »

Northwestern University

Chicago, IL United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Rush-Copley Healthcare Center

Yorkville, IL United States
  Connect »

Alegent Health Mercy Hospital

Council Bluffs, IA United States
  Connect »

Mercy Medical Center-West Lakes

West Des Moines, IA United States
  Connect »

Flaget Memorial Hospital

Bardstown, KY United States
  Connect »

Saint Joseph Hospital East

Lexington, KY United States
  Connect »

Saint Joseph London

London, KY United States
  Connect »

Jewish Hospital

Louisville, KY United States
  Connect »

Jewish Hospital Medical Center South

Shepherdsville, KY United States
  Connect »

Bronson Battle Creek

Battle Creek, MI United States
  Connect »

Bronson Methodist Hospital

Kalamazoo, MI United States
  Connect »

West Michigan Cancer Center

Kalamazoo, MI United States
  Connect »

Borgess Medical Center

Kalamazoo, MI United States
  Connect »

Mercy Health Mercy Campus

Muskegon, MI United States
  Connect »

Lakeland Hospital Niles

Niles, MI United States
  Connect »

Huron Medical Center PC

Port Huron, MI United States
  Connect »

Lake Huron Medical Center

Port Huron, MI United States
  Connect »

Marie Yeager Cancer Center

Saint Joseph, MI United States
  Connect »

Munson Medical Center

Traverse City, MI United States
  Connect »

Metro Health Hospital

Wyoming, MI United States
  Connect »

Fairview Ridges Hospital

Burnsville, MN United States
  Connect »

Miller-Dwan Hospital

Duluth, MN United States
  Connect »

Essentia Health - Fosston

Fosston, MN United States
  Connect »

Unity Hospital

Fridley, MN United States
  Connect »

Abbott-Northwestern Hospital

Minneapolis, MN United States
  Connect »

Hennepin County Medical Center

Minneapolis, MN United States
  Connect »

Health Partners Inc

Minneapolis, MN United States
  Connect »

Monticello Cancer Center

Monticello, MN United States
  Connect »

New Ulm Medical Center

New Ulm, MN United States
  Connect »

Essentia Health - Park Rapids

Park Rapids, MN United States
  Connect »

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, MN United States
  Connect »

Regions Hospital

Saint Paul, MN United States
  Connect »

United Hospital

Saint Paul, MN United States
  Connect »

Essentia Health Sandstone

Sandstone, MN United States
  Connect »

Lakeview Hospital

Stillwater, MN United States
  Connect »

Ridgeview Medical Center

Waconia, MN United States
  Connect »

Rice Memorial Hospital

Willmar, MN United States
  Connect »

The West Clinic - Corinth

Corinth, MS United States
  Connect »

Saint Vincent Healthcare

Billings, MT United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

Great Falls Clinic

Great Falls, MT United States
  Connect »

Community Medical Hospital

Missoula, MT United States
  Connect »

CHI Health Saint Francis

Grand Island, NE United States
  Connect »

CHI Health Good Samaritan

Kearney, NE United States
  Connect »

Midlands Community Hospital

Papillion, NE United States
  Connect »

Desert West Surgery

Las Vegas, NV United States
  Connect »

21st Century Oncology

Las Vegas, NV United States
  Connect »

Ann M Wierman MD LTD

Las Vegas, NV United States
  Connect »

University Cancer Center

Las Vegas, NV United States
  Connect »

Wayne Memorial Hospital

Goldsboro, NC United States
  Connect »

Onslow Memorial Hospital

Jacksonville, NC United States
  Connect »

Indu and Raj Soin Medical Center

Beavercreek, OH United States
  Connect »

Miami Valley Hospital South

Centerville, OH United States
  Connect »

Bethesda North Hospital

Cincinnati, OH United States
  Connect »

Mount Carmel East Hospital

Columbus, OH United States
  Connect »

Riverside Methodist Hospital

Columbus, OH United States
  Connect »

Grant Medical Center

Columbus, OH United States
  Connect »

Doctors Hospital

Columbus, OH United States
  Connect »

Miami Valley Hospital

Dayton, OH United States
  Connect »

Grady Memorial Hospital

Delaware, OH United States
  Connect »

Armes Family Cancer Center

Findlay, OH United States
  Connect »

Blanchard Valley Hospital

Findlay, OH United States
  Connect »

Orion Cancer Care

Findlay, OH United States
  Connect »

Dayton Physicians LLC-Atrium

Franklin, OH United States
  Connect »

Dayton Physicians LLC-Wayne

Greenville, OH United States
  Connect »

Wayne Hospital

Greenville, OH United States
  Connect »

Greater Dayton Cancer Center

Kettering, OH United States
  Connect »

First Dayton Cancer Care

Kettering, OH United States
  Connect »

Kettering Medical Center

Kettering, OH United States
  Connect »

Fairfield Medical Center

Lancaster, OH United States
  Connect »

OhioHealth Mansfield Hospital

Mansfield, OH United States
  Connect »

Marietta Memorial Hospital

Marietta, OH United States
  Connect »

Knox Community Hospital

Mount Vernon, OH United States
  Connect »

Licking Memorial Hospital

Newark, OH United States
  Connect »

Newark Radiation Oncology

Newark, OH United States
  Connect »

Southern Ohio Medical Center

Portsmouth, OH United States
  Connect »

Saint Ann's Hospital

Westerville, OH United States
  Connect »

Saint Francis Hospital

Greenville, SC United States
  Connect »

Memorial Hospital

Chattanooga, TN United States
  Connect »

The West Clinic - Wolf River

Germantown, TN United States
  Connect »

The West Clinic - Mid-Town

Memphis, TN United States
  Connect »

Memorial GYN Plus

Ooltewah, TN United States
  Connect »

Harrison Medical Center

Bremerton, WA United States
  Connect »

Saint Elizabeth Hospital

Enumclaw, WA United States
  Connect »

Saint Francis Hospital

Federal Way, WA United States
  Connect »

Saint Clare Hospital

Lakewood, WA United States
  Connect »

United Hospital Center

Bridgeport, WV United States
  Connect »

WVUH-Berkely Medical Center

Martinsburg, WV United States
  Connect »

Camden Clark Medical Center

Parkersburg, WV United States
  Connect »

Duluth Clinic Ashland

Ashland, WI United States
  Connect »

Aurora Health Center-Fond du Lac

Fond Du Lac, WI United States
  Connect »

Aurora Cancer Care-Grafton

Grafton, WI United States
  Connect »

Aurora BayCare Medical Center

Green Bay, WI United States
  Connect »

Aurora Cancer Care-Milwaukee

Milwaukee, WI United States
  Connect »

Aurora Sinai Medical Center

Milwaukee, WI United States
  Connect »

Cancer Center of Western Wisconsin

New Richmond, WI United States
  Connect »

Aurora Cancer Care-Racine

Racine, WI United States
  Connect »

Billings Clinic-Cody

Cody, WY United States
  Connect »

Welch Cancer Center

Sheridan, WY United States
  Connect »

Hope Cancer Care of Nevada

Las Vegas, NV United States
  Connect »

Henry Ford Hospital

Detroit, MI United States
  Connect »

Allegiance Health

Jackson, MI United States
  Connect »

Henry Ford West Bloomfield Hospital

West Bloomfield, MI United States
  Connect »

Sandra L Maxwell Cancer Center

Cedar City, UT United States
  Connect »

Logan Regional Hospital

Logan, UT United States
  Connect »

Riverton Hospital

Riverton, UT United States
  Connect »

LDS Hospital

Salt Lake City, UT United States
  Connect »

UW Cancer Center Johnson Creek

Johnson Creek, WI United States
  Connect »

Cambridge Medical Center

Cambridge, MN United States
  Connect »

Dublin Methodist Hospital

Dublin, OH United States
  Connect »

Mercy Hospital South

Saint Louis, MO United States
  Connect »

Las Vegas Urology - Pebble

Henderson, NV United States
  Connect »

Las Vegas Urology - Pecos

Las Vegas, NV United States
  Connect »

Kaiser Permanente-Anaheim

Anaheim, CA United States
  Connect »

Kaiser Permanente-Baldwin Park

Baldwin Park, CA United States
  Connect »

Kaiser Permanente-Bellflower

Bellflower, CA United States
  Connect »

Kaiser Permanente-Fontana

Fontana, CA United States
  Connect »

Kaiser Permanente - Harbor City

Harbor City, CA United States
  Connect »

Kaiser Permanente-Irvine

Irvine, CA United States
  Connect »

Kaiser Permanente-Cadillac

Los Angeles, CA United States
  Connect »

Kaiser Permanente - Panorama City

Panorama City, CA United States
  Connect »

Kaiser Permanente-Riverside

Riverside, CA United States
  Connect »

Kaiser Permanente-San Marcos

San Marcos, CA United States
  Connect »

City of Hope Upland

Upland, CA United States
  Connect »

Kaiser Permanente-Woodland Hills

Woodland Hills, CA United States
  Connect »

Rose Medical Center

Denver, CO United States
  Connect »

Sky Ridge Medical Center

Lone Tree, CO United States
  Connect »

OptumCare Cancer Care at Oakey

Las Vegas, NV United States
  Connect »

Las Vegas Urology - Sunset

Las Vegas, NV United States
  Connect »

Epic Care-Dublin

Dublin, CA United States
  Connect »

Bay Area Breast Surgeons Inc

Emeryville, CA United States
  Connect »

Broadlawns Medical Center

Des Moines, IA United States
  Connect »

Methodist West Hospital

West Des Moines, IA United States
  Connect »