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

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

December 6, 2022

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2027

Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Locally Recurrent Head and Neck Squamous Cell CarcinomaLocally Recurrent Hypopharyngeal Squamous Cell CarcinomaLocally Recurrent Laryngeal Squamous Cell CarcinomaLocally Recurrent Oral Cavity Squamous Cell CarcinomaLocally Recurrent Oropharyngeal Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic MelanomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaRecurrent MelanomaStage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Unresectable Melanoma
Interventions
PROCEDURE

Biopsy Procedure

Undergo tumor biopsies

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT scans

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI scans

BIOLOGICAL

Nivolumab

Given IV

Trial Locations (209)

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

11042

ACTIVE_NOT_RECRUITING

Northwell Health/Center for Advanced Medicine, Lake Success

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

19090

ACTIVE_NOT_RECRUITING

Asplundh Cancer Pavilion, Willow Grove

19107

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

19114

ACTIVE_NOT_RECRUITING

Jefferson Torresdale Hospital, Philadelphia

19713

RECRUITING

Helen F Graham Cancer Center, Newark

RECRUITING

Medical Oncology Hematology Consultants PA, Newark

22031

RECRUITING

Inova Schar Cancer Institute, Fairfax

22033

RECRUITING

Inova Fair Oaks Hospital, Fairfax

22042

RECRUITING

Inova Fairfax Hospital, Falls Church

22304

RECRUITING

Inova Alexandria Hospital, Alexandria

23229

RECRUITING

Virginia Cancer Institute, Richmond

23235

RECRUITING

VCU Massey Cancer Center at Stony Point, Richmond

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

24501

RECRUITING

Centra Alan B Pearson Regional Cancer Center, Lynchburg

27534

RECRUITING

Southeastern Medical Oncology Center-Goldsboro, Goldsboro

28328

RECRUITING

Southeastern Medical Oncology Center-Clinton, Clinton

28546

RECRUITING

Southeastern Medical Oncology Center-Jacksonville, Jacksonville

45331

RECRUITING

Miami Valley Cancer Care and Infusion, Greenville

45373

RECRUITING

Upper Valley Medical Center, Troy

45409

RECRUITING

Premier Blood and Cancer Center, Dayton

45415

RECRUITING

Miami Valley Hospital North, Dayton

45459

RECRUITING

Miami Valley Hospital South, Centerville

48106

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

RECRUITING

Huron Gastroenterology PC, Ypsilanti

48109

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

48114

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

RECRUITING

Trinity Health Medical Center - Brighton, Brighton

48118

RECRUITING

Chelsea Hospital, Chelsea

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea

48154

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48188

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton

RECRUITING

Trinity Health Medical Center - Canton, Canton

48197

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti

48201

ACTIVE_NOT_RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

48334

ACTIVE_NOT_RECRUITING

Weisberg Cancer Treatment Center, Farmington Hills

48341

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac

48503

RECRUITING

Cancer Hematology Centers - Flint, Flint

SUSPENDED

Genesee Hematology Oncology PC, Flint

RECRUITING

Genesys Hurley Cancer Institute, Flint

RECRUITING

Hurley Medical Center, Flint

48912

RECRUITING

University of Michigan Health - Sparrow Lansing, Lansing

49007

RECRUITING

Bronson Methodist Hospital, Kalamazoo

RECRUITING

West Michigan Cancer Center, Kalamazoo

49009

RECRUITING

Beacon Kalamazoo Cancer Center, Kalamazoo

49017

RECRUITING

Bronson Battle Creek, Battle Creek

49085

RECRUITING

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph

49120

RECRUITING

Corewell Health Lakeland Hospitals - Niles Hospital, Niles

49444

RECRUITING

Trinity Health Muskegon Hospital, Muskegon

RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores

49503

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

RECRUITING

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

RECRUITING

University of Michigan Health - West, Wyoming

49677

RECRUITING

Corewell Health Reed City Hospital, Reed City

49684

RECRUITING

Munson Medical Center, Traverse City

50010

RECRUITING

Mary Greeley Medical Center, Ames

RECRUITING

McFarland Clinic - Ames, Ames

50023

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny

50036

RECRUITING

McFarland Clinic - Boone, Boone

50129

RECRUITING

McFarland Clinic - Jefferson, Jefferson

50158

RECRUITING

McFarland Clinic - Marshalltown, Marshalltown

50263

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee

50309

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines

50314

RECRUITING

Mercy Medical Center - Des Moines, Des Moines

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines

50325

RECRUITING

Mercy Cancer Center-West Lakes, Clive

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive

50501

RECRUITING

McFarland Clinic - Trinity Cancer Center, Fort Dodge

52403

RECRUITING

Mercy Hospital, Cedar Rapids

RECRUITING

Oncology Associates at Mercy Medical Center, Cedar Rapids

53066

RECRUITING

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53149

RECRUITING

ProHealth D N Greenwald Center, Mukwonago

53188

RECRUITING

ProHealth Waukesha Memorial Hospital, Waukesha

RECRUITING

UW Cancer Center at ProHealth Care, Waukesha

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

54449

RECRUITING

Marshfield Medical Center-Marshfield, Marshfield

54476

RECRUITING

Marshfield Medical Center - Weston, Weston

54482

RECRUITING

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54548

RECRUITING

Marshfield Medical Center - Minocqua, Minocqua

54601

RECRUITING

Gundersen Lutheran Medical Center, La Crosse

54701

RECRUITING

Marshfield Medical Center-EC Cancer Center, Eau Claire

54806

RECRUITING

Duluth Clinic Ashland, Ashland

54868

RECRUITING

Marshfield Medical Center-Rice Lake, Rice Lake

54880

RECRUITING

Essentia Health Saint Mary's Hospital - Superior, Superior

55072

RECRUITING

Essentia Health Sandstone, Sandstone

55101

RECRUITING

Regions Hospital, Saint Paul

55102

RECRUITING

United Hospital, Saint Paul

55125

RECRUITING

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55387

RECRUITING

Ridgeview Medical Center, Waconia

55407

RECRUITING

Abbott-Northwestern Hospital, Minneapolis

55416

RECRUITING

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55432

ACTIVE_NOT_RECRUITING

Unity Hospital, Fridley

55433

RECRUITING

Mercy Hospital, Coon Rapids

55435

RECRUITING

Fairview Southdale Hospital, Edina

55746

RECRUITING

Essentia Health Hibbing Clinic, Hibbing

55792

RECRUITING

Essentia Health Virginia Clinic, Virginia

55805

RECRUITING

Essentia Health Cancer Center, Duluth

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

56401

RECRUITING

Essentia Health Saint Joseph's Medical Center, Brainerd

56470

RECRUITING

Essentia Health - Park Rapids, Park Rapids

56501

RECRUITING

Essentia Health Saint Mary's - Detroit Lakes Clinic, Detroit Lakes

56542

RECRUITING

Essentia Health - Fosston, Fosston

56601

RECRUITING

Sanford Joe Lueken Cancer Center, Bemidji

56636

RECRUITING

Essentia Health - Deer River Clinic, Deer River

57104

RECRUITING

Sanford Cancer Center Oncology Clinic, Sioux Falls

57701

RECRUITING

Rapid City Regional Hospital, Rapid City

58103

RECRUITING

Essentia Health Cancer Center-South University Clinic, Fargo

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

RECRUITING

Sanford Roger Maris Cancer Center, Fargo

58401

RECRUITING

Essentia Health - Jamestown Clinic, Jamestown

58501

RECRUITING

Sanford Bismarck Medical Center, Bismarck

59101

RECRUITING

Billings Clinic Cancer Center, Billings

59405

RECRUITING

Benefis Sletten Cancer Institute, Great Falls

59711

RECRUITING

Community Hospital of Anaconda, Anaconda

59715

RECRUITING

Bozeman Health Deaconess Hospital, Bozeman

59804

RECRUITING

Community Medical Center, Missoula

59901

RECRUITING

Logan Health Medical Center, Kalispell

60045

RECRUITING

Northwestern Medicine Lake Forest Hospital, Lake Forest

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60462

RECRUITING

Northwestern Medicine Orland Park, Orland Park

60504

SUSPENDED

Rush-Copley Medical Center, Aurora

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

60560

SUSPENDED

Rush-Copley Healthcare Center, Yorkville

60611

RECRUITING

Northwestern University, Chicago

60612

RECRUITING

University of Illinois, Chicago

61021

RECRUITING

Illinois CancerCare-Dixon, Dixon

61350

RECRUITING

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

RECRUITING

Illinois CancerCare-Peru, Peru

61356

RECRUITING

Illinois CancerCare-Princeton, Princeton

61401

RECRUITING

Illinois CancerCare-Galesburg, Galesburg

61443

RECRUITING

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

RECRUITING

Illinois CancerCare-Macomb, Macomb

61520

RECRUITING

Illinois CancerCare-Canton, Canton

61530

RECRUITING

Illinois CancerCare-Eureka, Eureka

61554

RECRUITING

Illinois CancerCare-Pekin, Pekin

61571

RECRUITING

Illinois CancerCare - Washington, Washington

61615

RECRUITING

Illinois CancerCare-Peoria, Peoria

61704

RECRUITING

Illinois CancerCare-Bloomington, Bloomington

61801

RECRUITING

Carle Cancer Center, Urbana

61832

RECRUITING

Carle at The Riverfront, Danville

61938

RECRUITING

Carle Physician Group-Mattoon/Charleston, Mattoon

62269

RECRUITING

Cancer Care Center of O'Fallon, O'Fallon

RECRUITING

Memorial Hospital East, Shiloh

62321

RECRUITING

Illinois CancerCare-Carthage, Carthage

62401

RECRUITING

Carle Physician Group-Effingham, Effingham

RECRUITING

Crossroads Cancer Center, Effingham

62526

RECRUITING

Cancer Care Specialists of Illinois - Decatur, Decatur

RECRUITING

Decatur Memorial Hospital, Decatur

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

RECRUITING

Springfield Clinic, Springfield

62781

RECRUITING

Springfield Memorial Hospital, Springfield

62801

RECRUITING

Centralia Oncology Clinic, Centralia

63110

RECRUITING

Washington University School of Medicine, St Louis

63128

RECRUITING

Mercy Hospital South, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, St Louis

63136

RECRUITING

Siteman Cancer Center at Christian Hospital, St Louis

63141

RECRUITING

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

RECRUITING

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

63703

RECRUITING

Saint Francis Medical Center, Cape Girardeau

68118

RECRUITING

Nebraska Medicine-Village Pointe, Omaha

68123

RECRUITING

Nebraska Medicine-Bellevue, Bellevue

68198

RECRUITING

University of Nebraska Medical Center, Omaha

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

80045

ACTIVE_NOT_RECRUITING

Rocky Mountain Regional VA Medical Center, Aurora

80524

RECRUITING

Poudre Valley Hospital, Fort Collins

80528

RECRUITING

Cancer Care and Hematology-Fort Collins, Fort Collins

80538

RECRUITING

Medical Center of the Rockies, Loveland

80631

RECRUITING

UCHealth Greeley Hospital, Greeley

80909

RECRUITING

UCHealth Memorial Hospital Central, Colorado Springs

80920

RECRUITING

Memorial Hospital North, Colorado Springs

83301

RECRUITING

Saint Luke's Cancer Institute - Twin Falls, Twin Falls

83605

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83619

RECRUITING

Saint Luke's Cancer Institute - Fruitland, Fruitland

83642

RECRUITING

Saint Luke's Cancer Institute - Meridian, Meridian

83687

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa, Nampa

RECRUITING

Saint Luke's Cancer Institute - Nampa, Nampa

83706

RECRUITING

Saint Alphonsus Cancer Care Center-Boise, Boise

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

83814

RECRUITING

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

RECRUITING

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint, Sandpoint

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

85054

RECRUITING

Mayo Clinic Hospital in Arizona, Phoenix

87106

RECRUITING

University of New Mexico Cancer Center, Albuquerque

90025

RECRUITING

The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90211

RECRUITING

Tower Cancer Research Foundation, Beverly Hills

92612

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine

92868

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

96701

RECRUITING

Hawaii Cancer Care - Westridge, ‘Aiea

96813

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu

RECRUITING

Queen's Cancer Cenrer - POB I, Honolulu

RECRUITING

Queen's Medical Center, Honolulu

96817

RECRUITING

Queen's Cancer Center - Kuakini, Honolulu

97015

RECRUITING

Clackamas Radiation Oncology Center, Clackamas

97045

RECRUITING

Providence Willamette Falls Medical Center, Oregon City

97132

RECRUITING

Providence Newberg Medical Center, Newberg

97213

RECRUITING

Providence Portland Medical Center, Portland

97225

RECRUITING

Providence Saint Vincent Medical Center, Portland

97701

RECRUITING

Saint Charles Health System, Bend

97914

RECRUITING

Saint Alphonsus Cancer Care Center-Ontario, Ontario

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville

02111

RECRUITING

Tufts Medical Center, Boston

01199

RECRUITING

Baystate Medical Center, Springfield

45005-1066

RECRUITING

Atrium Medical Center-Middletown Regional Hospital, Franklin

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH