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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Siwen Hu-Lieskovan

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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