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RECRUITING

NCT05111574

PHASE2

Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase II Trial of Adjuvant Nivolumab With or Without Cabozantinib in Patients With Resected Mucosal Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

101

Start Date

2022-08-11

Completion Date

2026-09-01

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Anal Melanoma Bladder Melanoma Cervical Melanoma Esophageal Melanoma Gallbladder Melanoma Head and Neck Mucosal Melanoma Mucosal Melanoma Nasopharyngeal Mucosal Melanoma Oral Cavity Mucosal Melanoma Penile Mucosal Melanoma Rectal Melanoma Recurrent Mucosal Melanoma Sinonasal Mucosal Melanoma Urethral Melanoma Urinary System Mucosal Melanoma Vaginal Melanoma Vulvar Melanoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

DRUG

Placebo Administration

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET

Inclusion Criteria: * STEP 0 INCLUSION CRITERIA * Histologically proven mucosal melanoma by local pathology * Central PD-L1 tumor tissue submission * STEP 1 INCLUSION CRITERIA * Receipt of the central PD-L1 testing results available * Report is required for randomization of resection R0 or R1 patients * Testing must be started in Step 0 but results can be reported after registration for resection R2 patients * Disease status-Resected R0 or R1 disease patients. Patients eligible for randomization have resected R0 or R1 disease (with negative margins or positive microscopic margins) that must meet one of the following 4 criteria as defined below: * Regional lymph node (LN) involvement; OR * In-transit metastases/satellite primary disease; OR * Single localized, primary disease meeting one of the following site-specific requirements: * Head/neck - Sinonasal (including nasopharynx): any primary lesion; Nasal or oral cavity; pT4a or above, given slightly improved OS * NOTE: Conjunctival: does not meet the qualification for eligibility * Anorectal - any primary lesion * Vaginal/cervical - any primary, as they have 5 year OS rates of 5-25% * Urinary tract - any primary urethral or bladder tumor * Penile * Vulvar- American Joint Committee on Cancer (AJCC) cutaneous stage IIB or higher * Esophageal/gallbladder - any primary * Locoregionally recurrent following prior resection, meeting at least one of the above criteria * In addition, patients must have undergone cross-sectional imaging of the brain, chest, abdomen and pelvis with no evidence of distant metastatic disease * Disease status-Non-resected R2 or metastatic disease patients * Non-resected R2 or metastatic disease that is assessable and measurable radiographically or by physical examination * Prior Treatment: * No prior systemic checkpoint inhibitor therapy of mucosal melanoma, including in the adjuvant setting, is allowed. Prior adjuvant chemotherapy or interferon is allowed. * No other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator. Exceptions may allow for adjuvant no evidence of disease (NED) cancers undergoing hormone based therapy may be eligible pending the other eligibility criteria are met and the principal investigator (PI) affirms the hormonal agent would not change the melanoma response. * Any radiation must have completed 28 days prior to randomization and the patient must have adequately recovered from its effects. * For resectable patients only: Surgery must have completed 28 days prior to randomization. * For resectable patients only: Surgery must have completed no more than 84 days prior to randomization. * Not pregnant and not nursing, because this study has an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) \>= 50mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Albumin \>= 2.8 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * No cardiovascular disease, including: * No history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft (CABG) coronary angioplasty, or stenting within 6 months prior to study entry. * No history of current class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system. * No refractory hypertension defined as a blood pressure of systolic \> 140 mmHg and/or diastolic \> 90 mmHg despite adequate attempts at anti-hypertensive therapy. * No history of myocarditis. * No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months. * No corrected QT interval by Fridericia's formula (QTcF) \> 500 msec. Note: if initial QTcF is found to be \> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\< 500 ms, the subject meets eligibility in this regard. * No underlying hematologic issues, including: * Congenital bleeding diathesis * Gastrointestinal (GI) bleeding requiring intervention within the past 6 months, unless directly related to mucosal melanoma * Active hemoptysis within 42 days prior to study enrollment. * Active tumor lesions with cavitations or tumor lesions which invade, encase, or abut major blood vessels. The anatomic location and characteristics of primary tumors or metastases as well as the medical history should be carefully reviewed in the selection of subjects for treatment with cabozantinib/placebo. * Pulmonary emboli or deep vein thromboses (DVT) that require an active anticoagulation regimen. * No known or suspected history of cytopenia (low white blood cell \[WBC\], hemoglobin or platelet count) of greater than 3 months duration with an unknown cause, myelodysplastic syndrome, or hematologic malignancies. * No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of pre-registration (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics). * No known or suspected gastrointestinal disorder affecting absorption of oral medications. * Comorbid conditions: * No active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * No history of autoimmune motor neuropathy (e.g., Guillain-Barre syndrome, myasthenia gravis) or non-infectious pneumonitis. * No history of severe allergic reactions to an unknown allergen or any components of the study drugs or its excipients. * No history of gastrointestinal perforation or abdominal fistula. * No clinically suspected central nervous system (CNS) (leptomeningeal or parenchymal) metastases. Patients with a history of CNS metastasis(s) will be allowed as long as * The metastatic site(s) were adequately treated as demonstrated by clinical and radiographic improvement, AND * The patient has recovered from the intervention (no residual adverse events \> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 1), AND * The patient has remained without occurrence of new or worsening CNS symptoms for a period of 28 days prior to enrollment. * No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma) within 2 years. * No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction. * No untreated spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression. Spinal metastases must have completed planned radiation or surgical therapy prior to registration. * Concomitant medications: * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 5 days prior to the start of study treatment. * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 5 days prior to the start of study treatment.

Locations (147)

Sutter Auburn Faith Hospital

Auburn, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Keck Medicine of USC Koreatown

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

Memorial Medical Center

Modesto, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Mills Health Center

San Mateo, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Saint Alphonsus Cancer Care Center-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 Alphonsus Cancer Care Center-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

Rush-Copley Medical Center

Aurora, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

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

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, 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

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, 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

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

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

Clive, 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

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Bronson Battle Creek

Battle Creek, 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

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

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

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, 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

Parkland Health Center - Farmington

Farmington, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, 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

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Hematology Oncology Associates of CNY at Camillus

Camillus, New York, United States

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, 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

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Premier Blood and Cancer Center

Dayton, Ohio, United States

Dayton Physician LLC - Englewood

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

Kettering Medical Center

Kettering, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

M D Anderson Cancer Center

Houston, Texas, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

HSHS Sacred Heart Hospital

Eau Claire, 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

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, 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

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Clinical Research Directory

Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (147)