Actively Recruiting
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
Led by National Cancer Institute (NCI) ยท Updated on 2026-05-13
101
Participants Needed
147
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. 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. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.
CONDITIONS
Official Title
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed mucosal melanoma
- Central PD-L1 tumor tissue submission
- Central PD-L1 testing results available for randomization
- Resected R0 or R1 disease meeting specific criteria (regional lymph node involvement, in-transit metastases, or site-specific disease requirements)
- Locoregionally recurrent disease meeting above criteria
- Cross-sectional imaging showing no distant metastatic disease
- Non-resected R2 or metastatic disease measurable by imaging or exam
- No prior systemic checkpoint inhibitor therapy for mucosal melanoma
- Prior adjuvant chemotherapy or interferon allowed
- Completed radiation at least 28 days before randomization
- For resectable patients, surgery completed 28 to 84 days prior to randomization
- Not pregnant or nursing; negative pregnancy test within 7 days prior to registration for women of childbearing potential
- Age 18 years or older
- ECOG performance status 0-2
- Adequate blood counts and organ function as specified
- No active cardiovascular disease or significant cardiac history
- No active hematologic disorders or bleeding risks
- No active infections requiring treatment
- No gastrointestinal disorders affecting oral medication absorption
- No active autoimmune disease or recent immunosuppressive treatment
- No history of severe allergic reactions to study drugs
- No history of gastrointestinal perforation or fistula
- No active CNS metastases or seizure risk conditions
- No significant liver disease or untreated spinal cord compression
- No chronic treatment with strong CYP3A4 inhibitors or inducers
You will not qualify if you...
- History of acute coronary syndromes, coronary angioplasty, or stenting within 6 months
- Current class II or higher congestive heart failure
- Refractory hypertension despite treatment
- History of myocarditis or syncope of cardiovascular cause
- Uncontrolled cardiac arrhythmias or certain heart blocks without pacemaker
- QTcF interval greater than 500 msec confirmed by multiple EKGs
- Congenital bleeding disorders or recent GI bleeding unrelated to melanoma
- Active hemoptysis within 42 days prior to enrollment
- Tumors invading or encasing major blood vessels
- Pulmonary embolism or deep vein thrombosis requiring active anticoagulation
- Known or suspected cytopenia of unknown cause lasting more than 3 months
- Active bacterial, fungal, or viral infections requiring treatment
- Active autoimmune motor neuropathy or non-infectious pneumonitis
- History of severe allergic reactions to unknown allergens or study drug components
- History of gastrointestinal perforation or abdominal fistula
- Clinically suspected untreated CNS metastases
- History of seizure or conditions increasing seizure risk within 2 years
- Active or chronic liver disease causing moderate/severe impairment
- Untreated spinal metastases with risk of fracture or compression
- Use of strong CYP3A4 inhibitors or inducers within 5 days prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 147 locations
1
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
Actively Recruiting
2
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Actively Recruiting
3
Palo Alto Medical Foundation-Fremont
Fremont, California, United States, 94538
Actively Recruiting
4
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
5
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
6
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
7
Memorial Medical Center
Modesto, California, United States, 95355
Actively Recruiting
8
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
9
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Suspended
10
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
11
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Actively Recruiting
12
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
13
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Actively Recruiting
14
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
15
Mills Health Center
San Mateo, California, United States, 94401
Actively Recruiting
16
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Actively Recruiting
17
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
18
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94086
Actively Recruiting
19
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States, 94589
Actively Recruiting
20
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States, 80113
Active, Not Recruiting
21
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Active, Not Recruiting
22
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Active, Not Recruiting
23
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Active, Not Recruiting
24
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Active, Not Recruiting
25
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Active, Not Recruiting
26
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Suspended
27
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Suspended
28
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
29
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Suspended
30
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
31
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
32
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
Actively Recruiting
33
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Actively Recruiting
34
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
35
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
36
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
37
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
38
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
39
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
40
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Actively Recruiting
41
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
42
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
43
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
44
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
45
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
46
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States, 62269
Actively Recruiting
47
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
48
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
49
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
50
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
51
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
52
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
53
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
Actively Recruiting
54
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
55
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
56
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
57
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
58
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
59
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
60
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
61
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
62
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
63
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
64
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
65
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
66
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Actively Recruiting
67
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
68
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
69
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
70
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
71
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, United States, 49009
Actively Recruiting
72
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States, 49444
Actively Recruiting
73
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States, 49120
Actively Recruiting
74
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States, 49444
Actively Recruiting
75
Corewell Health Reed City Hospital
Reed City, Michigan, United States, 49677
Actively Recruiting
76
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
77
Munson Medical Center
Traverse City, Michigan, United States, 49684
Actively Recruiting
78
University of Michigan Health - West
Wyoming, Michigan, United States, 49519
Actively Recruiting
79
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States, 55337
Actively Recruiting
80
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
81
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
82
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
83
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Actively Recruiting
84
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
85
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
86
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
87
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
88
Parkland Health Center - Farmington
Farmington, Missouri, United States, 63640
Actively Recruiting
89
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Actively Recruiting
90
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
91
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Actively Recruiting
92
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States, 63127
Actively Recruiting
93
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
94
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
95
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
96
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
97
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
98
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
99
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
100
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, United States, 13031
Actively Recruiting
101
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States, 13057
Actively Recruiting
102
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
103
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Actively Recruiting
104
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
105
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
106
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
107
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
108
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Actively Recruiting
109
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
110
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
111
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Actively Recruiting
112
Premier Blood and Cancer Center
Dayton, Ohio, United States, 45409
Actively Recruiting
113
Dayton Physician LLC - Englewood
Dayton, Ohio, United States, 45415
Active, Not Recruiting
114
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Actively Recruiting
115
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Actively Recruiting
116
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States, 45331
Actively Recruiting
117
Kettering Medical Center
Kettering, Ohio, United States, 45429
Active, Not Recruiting
118
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Actively Recruiting
119
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States, 73505
Suspended
120
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
121
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States, 97914
Suspended
122
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
123
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
124
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Active, Not Recruiting
125
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Active, Not Recruiting
126
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
127
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
128
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
129
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
130
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Suspended
131
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
132
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
133
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
134
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
135
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
136
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
137
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
138
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Actively Recruiting
139
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
140
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
141
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
142
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
143
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
144
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
145
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
146
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
147
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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