BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT05136196
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This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.
Interventions
-
Biopsy Procedure
(Procedure)
Undergo tumor biopsies
-
Biospecimen Collection
(Procedure)
Undergo collection of blood samples
-
Cabozantinib S-malate
(Drug)
Given PO
-
Computed Tomography
(Procedure)
Undergo CT scans
-
Magnetic Resonance Imaging
(Procedure)
Undergo MRI scans
-
Nivolumab
(Biological)
Given IV
Eligibility criteria
Conditions
Locations
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Tower Cancer Research Foundation — Beverly Hills, California, United States
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California, United States
- Los Angeles General Medical Center — Los Angeles, California, United States
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
- Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
- UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
- Memorial Hospital North — Colorado Springs, Colorado, United States
- Poudre Valley Hospital — Fort Collins, Colorado, United States
- Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
- UCHealth Greeley Hospital — Greeley, Colorado, United States
- Medical Center of the Rockies — Loveland, Colorado, United States
- Helen F Graham Cancer Center — Newark, Delaware, United States
- Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
- Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States
- Queen's Medical Center — Honolulu, Hawaii, United States
- Queen's Cancer Center - Kuakini — Honolulu, Hawaii, United States
- Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States
- Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
- Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
- Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
- Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States
- Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States
- Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho, United States
- Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, United States
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
- Saint Luke's Cancer Institute - Twin Falls — Twin Falls, Idaho, United States
- Rush-Copley Medical Center — Aurora, Illinois, United States
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Centralia Oncology Clinic — Centralia, Illinois, United States
- Northwestern University — Chicago, Illinois, United States
- University of Illinois — Chicago, Illinois, United States
- Carle at The Riverfront — Danville, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
- Illinois CancerCare-Dixon — Dixon, Illinois, United States
- Carle Physician Group-Effingham — Effingham, Illinois, United States
- Crossroads Cancer Center — Effingham, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
- Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
- Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States
- Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States
- Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
- Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
- Illinois CancerCare-Macomb — Macomb, Illinois, United States
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Carle BroMenn Medical Center — Normal, Illinois, United States
- Carle Cancer Institute Normal — Normal, Illinois, United States
- Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
- Northwestern Medicine Orland Park — Orland Park, Illinois, United States
- Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
- Illinois CancerCare-Pekin — Pekin, Illinois, United States
- Illinois CancerCare-Peoria — Peoria, Illinois, United States
- Illinois CancerCare-Peru — Peru, Illinois, United States
- Illinois CancerCare-Princeton — Princeton, Illinois, United States
- Memorial Hospital East — Shiloh, Illinois, United States
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
- Springfield Clinic — Springfield, Illinois, United States
- Springfield Memorial Hospital — Springfield, Illinois, United States
- Carle Cancer Center — Urbana, Illinois, United States
- Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
- Illinois CancerCare - Washington — Washington, Illinois, United States
- Rush-Copley Healthcare Center — Yorkville, Illinois, United States
- Mary Greeley Medical Center — Ames, Iowa, United States
- McFarland Clinic - Ames — Ames, Iowa, United States
- UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
- McFarland Clinic - Boone — Boone, Iowa, United States
- Mercy Hospital — Cedar Rapids, Iowa, United States
- Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
- Mercy Cancer Center-West Lakes — Clive, Iowa, United States
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
- UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
- Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
- McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
- McFarland Clinic - Jefferson — Jefferson, Iowa, United States
- McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States
- UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- Tufts Medical Center Cancer Center Stoneham — Stoneham, Massachusetts, United States
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor — Ann Arbor, Michigan, United States
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
- Bronson Battle Creek — Battle Creek, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
- Trinity Health Medical Center - Brighton — Brighton, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
- Trinity Health Medical Center - Canton — Canton, Michigan, United States
- Chelsea Hospital — Chelsea, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
- Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
- OSF Saint Francis Hospital and Medical Group — Escanaba, Michigan, United States
- Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States
- Cancer Hematology Centers - Flint — Flint, Michigan, United States
- Genesee Hematology Oncology PC — Flint, Michigan, United States
- Genesys Hurley Cancer Institute — Flint, Michigan, United States
- Hurley Medical Center — Flint, Michigan, United States
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
- Trinity Health Grand Rapids Hospital — Grand Rapids, Michigan, United States
- Bronson Methodist Hospital — Kalamazoo, Michigan, United States
- West Michigan Cancer Center — Kalamazoo, Michigan, United States
- Beacon Kalamazoo Cancer Center — Kalamazoo, Michigan, United States
- University of Michigan Health - Sparrow Lansing — Lansing, Michigan, United States
- Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
- Trinity Health Muskegon Hospital — Muskegon, Michigan, United States
- Corewell Health Lakeland Hospitals - Niles Hospital — Niles, Michigan, United States
- Cancer and Hematology Centers of Western Michigan - Norton Shores — Norton Shores, Michigan, United States
- Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
- Corewell Health Reed City Hospital — Reed City, Michigan, United States
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
- Munson Medical Center — Traverse City, Michigan, United States
- University of Michigan Health - West — Wyoming, Michigan, United States
- Huron Gastroenterology PC — Ypsilanti, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
- Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
- Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
- Minnesota Oncology - Burnsville — Burnsville, Minnesota, United States
- Minnesota Oncology Hematology PA-Chaska — Chaska, Minnesota, United States
- Mercy Hospital — Coon Rapids, Minnesota, United States
- Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
- Essentia Health Saint Mary's - Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States
- Essentia Health Cancer Center — Duluth, Minnesota, United States
- Fairview Southdale Hospital — Edina, Minnesota, United States
- Essentia Health - Fosston — Fosston, Minnesota, United States
- Unity Hospital — Fridley, Minnesota, United States
- Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
- Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States
- Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
- Essentia Health - Park Rapids — Park Rapids, Minnesota, United States
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
- Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
- Regions Hospital — Saint Paul, Minnesota, United States
- United Hospital — Saint Paul, Minnesota, United States
- Essentia Health Sandstone — Sandstone, Minnesota, United States
- Essentia Health Virginia Clinic — Virginia, Minnesota, United States
- Ridgeview Medical Center — Waconia, Minnesota, United States
- Minnesota Oncology Hematology PA-Woodbury — Woodbury, Minnesota, United States
- Saint Francis Medical Center — Cape Girardeau, Missouri, United States
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Mercy Hospital South — St Louis, Missouri, United States
- Siteman Cancer Center-South County — St Louis, Missouri, United States
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
- Community Hospital of Anaconda — Anaconda, Montana, United States
- Billings Clinic Cancer Center — Billings, Montana, United States
- Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
- Benefis Sletten Cancer Institute — Great Falls, Montana, United States
- Logan Health Medical Center — Kalispell, Montana, United States
- Community Medical Center — Missoula, Montana, United States
- Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
- Nebraska Medicine-Village Pointe — Omaha, Nebraska, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
- Northwell Health/Center for Advanced Medicine — Lake Success, New York, United States
- NYU Langone Hospital - Long Island — Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
- Southeastern Medical Oncology Center-Clinton — Clinton, North Carolina, United States
- Southeastern Medical Oncology Center-Goldsboro — Goldsboro, North Carolina, United States
- Southeastern Medical Oncology Center-Jacksonville — Jacksonville, North Carolina, United States
- Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
- Essentia Health Cancer Center-South University Clinic — Fargo, North Dakota, United States
- Sanford Broadway Medical Center — Fargo, North Dakota, United States
- Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
- Essentia Health - Jamestown Clinic — Jamestown, North Dakota, United States
- Miami Valley Hospital South — Centerville, Ohio, United States
- Premier Blood and Cancer Center — Dayton, Ohio, United States
- Miami Valley Hospital North — Dayton, Ohio, United States
- Atrium Medical Center-Middletown Regional Hospital — Franklin, Ohio, United States
- Miami Valley Cancer Care and Infusion — Greenville, Ohio, United States
- Upper Valley Medical Center — Troy, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Saint Charles Health System — Bend, Oregon, United States
- Clackamas Radiation Oncology Center — Clackamas, Oregon, United States
- Providence Newberg Medical Center — Newberg, Oregon, United States
- Saint Alphonsus Cancer Care Center-Ontario — Ontario, Oregon, United States
- Providence Willamette Falls Medical Center — Oregon City, Oregon, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- Providence Saint Vincent Medical Center — Portland, Oregon, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Jefferson Torresdale Hospital — Philadelphia, Pennsylvania, United States
- Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
- Rapid City Regional Hospital — Rapid City, South Dakota, United States
- Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
- Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
- Dartmouth Cancer Center - North — Saint Johnsbury, Vermont, United States
- Inova Alexandria Hospital — Alexandria, Virginia, United States
- Inova Schar Cancer Institute — Fairfax, Virginia, United States
- Inova Fair Oaks Hospital — Fairfax, Virginia, United States
- Inova Fairfax Hospital — Falls Church, Virginia, United States
- Centra Alan B Pearson Regional Cancer Center — Lynchburg, Virginia, United States
- Virginia Cancer Institute — Richmond, Virginia, United States
- VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
- VCU Health Tappahannock Hospital — Tappahannock, Virginia, United States
- Duluth Clinic Ashland — Ashland, Wisconsin, United States
- Marshfield Medical Center-EC Cancer Center — Eau Claire, Wisconsin, United States
- Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
- Saint Vincent Hospital Cancer Center at Saint Mary's — Green Bay, Wisconsin, United States
- Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
- Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Marshfield Medical Center - Minocqua — Minocqua, Wisconsin, United States
- ProHealth D N Greenwald Center — Mukwonago, Wisconsin, United States
- Cancer Center of Western Wisconsin — New Richmond, Wisconsin, United States
- ProHealth Oconomowoc Memorial Hospital — Oconomowoc, Wisconsin, United States
- Saint Vincent Hospital Cancer Center at Oconto Falls — Oconto Falls, Wisconsin, United States
- Marshfield Medical Center-Rice Lake — Rice Lake, Wisconsin, United States
- Saint Vincent Hospital Cancer Center at Sheboygan — Sheboygan, Wisconsin, United States
- Marshfield Medical Center-River Region at Stevens Point — Stevens Point, Wisconsin, United States
- Saint Vincent Hospital Cancer Center at Sturgeon Bay — Sturgeon Bay, Wisconsin, United States
- Essentia Health Saint Mary's Hospital - Superior — Superior, Wisconsin, United States
- ProHealth Waukesha Memorial Hospital — Waukesha, Wisconsin, United States
- UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States
- Marshfield Medical Center - Weston — Weston, Wisconsin, United States
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