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Brief Title: 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
Official Title: Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study
Study ID: NCT05136196
Brief Summary: 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.
Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the feasibility of molecular characterization based on tumor mutation burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. II. To evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for Tumor Inflammation Score \[TIS\]) for stratification as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in the overall study (Stage I and Stage II). III. To evaluate the efficacy by overall response rate (ORR - defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib S-malate (cabozantinib) plus nivolumab in each disease cohort, both across and within tumor biomarker subgroups. SECONDARY OBJECTIVES: I. To assess the difference in ORR in each disease cohort between tumor marker subgroups separately for each disease cohort. II. To assess safety and tolerability of this treatment in these populations. III. To estimate disease control rate (DCR) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers. IV. To estimate progression-free survival (PFS) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers. V. To estimate overall survival (OS) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers. VI. To assess the proportion of patients with assay failure, and the time from the date of tissue collection to molecular group determination at the end of Stage I. ADDITIONAL OBJECTIVE: I. To identify candidate biomarkers predictive of response and toxicity to the cabozantinib and nivolumab combination. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle and cabozantinib orally (PO) daily. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) scans and collection of blood samples throughout the trial. Patients undergo a tumor biopsy during screening and optionally during follow-up. After completion of the study treatment, patients are followed for up to 3 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, 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
Hawaii Cancer Care - Westridge, 'Aiea, 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
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 Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Kootenai Cancer Clinic, 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
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
Cancer Care Center of O'Fallon, O'Fallon, 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
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, 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
Mission Cancer and Blood - Ankeny, 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
Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Mission Cancer and Blood - Laurel, 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
Tufts Medical Center, Boston, Massachusetts, United States
Baystate Medical Center, Springfield, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States
University of Michigan Comprehensive 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
Saint Joseph Mercy Chelsea, 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
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center, 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
Ascension Borgess 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
Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, 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
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
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
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, 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
Kalispell Regional 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
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Northwell Health/Center for Advanced Medicine, Lake Success, 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 Medical 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
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
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
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Duluth Clinic Ashland, Ashland, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, 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
Name: Siwen Hu-Lieskovan
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR