RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-08-11

Study Completion:2024-12-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05111574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Alexander N Shoushtari

PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Study Locations (Sites)

Sutter Auburn Faith Hospital

Auburn, California, 95602

United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704

United States

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538

United States

Keck Medicine of USC Koreatown

Los Angeles, California, 90020

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Memorial Medical Center

Modesto, California, 95355

United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663

United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

Sutter Roseville Medical Center

Roseville, California, 95661

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065

United States

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403

United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086

United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Northwestern University

Chicago, Illinois, 60611

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023

United States

McFarland Clinic - Boone

Boone, Iowa, 50036

United States

Mission Cancer and Blood - West Des Moines

Clive, Iowa, 50325

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

Mission Cancer and Blood - Laurel

Des Moines, Iowa, 50314

United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

United States

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Ascension Borgess Cancer Center

Kalamazoo, Michigan, 49009

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090

United States

Rapid City Regional Hospital

Rapid City, South Dakota, 57701

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154

United States

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Alexander N Shoushtari, PRINCIPAL_INVESTIGATOR, Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-11

Study Completion Date2024-12-19

Study Record Updates

Study Start Date2022-08-11

Study Completion Date2024-12-19

Terms related to this study

Additional Relevant MeSH Terms

Anal Melanoma
Bladder Melanoma
Cervical Melanoma
Esophageal Melanoma
Gallbladder Melanoma
Mucosal Melanoma
Mucosal Melanoma of the Head and Neck
Mucosal Melanoma of the Urinary System
Nasopharyngeal Melanoma
Oral Cavity Mucosal Melanoma
Penile Mucosal Melanoma
Rectal Melanoma
Recurrent Mucosal Melanoma
Sinonasal Mucosal Melanoma
Stage II Vulvar Cancer AJCC v8
Stage III Vulvar Cancer AJCC v8
Stage IV Vulvar Cancer AJCC v8
Urethral Melanoma
Vaginal Melanoma
Vulvar Melanoma

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

Conditions

Quick Navigation

Study Overview

Description

Official Title

Quick Facts

Study ID

Participation Criteria

Contacts and Locations

Principal Investigator

Study Locations (Sites)

Collaborators and Investigators

Study Record Dates

Study Registration Dates

Study Record Updates

Terms related to this study

Additional Relevant MeSH Terms