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Anal MelanomaPhase 2NCT05111574

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

A Phase 2 study testing Biospecimen Collection, Bone Scan and Cabozantinib S-malate in people with Anal Melanoma and Bladder Melanoma, run by National Cancer Institute (NCI) at 146 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Melanoma, Bladder Melanoma, Cervical Melanoma
What is being tested?
Biospecimen Collection, Bone Scan and Cabozantinib S-malate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
146 sitesin 2 countries
Study dates
11 Aug 2022to 15 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 69Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

146 sites in 2 countries.

146 sites in 2 countries

United States142 sites

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Northwestern University

    Chicago, Illinois, 60611

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

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

    Clive, Iowa, 50325

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Keck Medicine of USC Koreatown

    Los Angeles, California, 90020

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59804

  • Memorial Medical Center

    Modesto, California, 95355

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California, 92663

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • Mills Health Center

    San Mateo, California, 94401

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Saint Vincent Hospital Cancer Center at Sheboygan

    Sheboygan, Wisconsin, 53081

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

Other trials in United States

Canada4 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the efficacy of adjuvant nivolumab (480 mg every [q]4 weeks) versus nivolumab plus cabozantinib s-malate (cabozantinib) (40 mg daily) in patients with mucosal melanoma.

SECONDARY OBJECTIVES:

  1. To compare overall survival between the two adjuvant therapies. II. To evaluate the adverse effects in each arm. III. To assess the correlation between PD-L1 expression in tumor cells with survival (recurrence free survival [RFS] and overall survival [OS]).

IV. To evaluate the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), and OS of nivolumab plus cabozantinib in patients who cannot undergo gross total resection of disease or have metastatic disease at baseline.

  1. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

OUTLINE: Patients whose tumor has been fully removed by surgery are randomized to Arm 1 or Arm 2. Patients whose tumor has not been fully removed by surgery or has spread are assigned to Arm 3.

ARM 1: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and cabozantinib orally (PO) once daily (QD) of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive nivolumab IV over 30 minutes on day 1 and placebo PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.

ARM 3: Patients receive nivolumab IV over 30 minutes and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo echocardiogram (ECHO) during screening and as clinically indicated throughout the trial. Patients may undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.

After completion of study treatment, patients are followed up every 3 months until disease progression, and then every 6 months for up to 5 years from registration or until death.

Being tested
Biospecimen Collection, Bone Scan, Cabozantinib S-malate, Computed Tomography, Echocardiography Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and tissue sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Cabozantinib S-malateDrug

    Also called BMS-907351, Cabometyx, Cometriq, XL 184

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • Placebo AdministrationDrug

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

Study groups in NCT05111574
Study groupRoleWhat they receive
Arm 1 (nivolumab, cabozantinib)ExperimentalPatients receive nivolumab IV over 30 minutes on day 1 and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabozantinib S-malate; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography
Arm 2 (nivolumab, placebo)Active comparatorPatients receive nivolumab IV over 30 minutes on day 1 and placebo PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Drug: Placebo Administration; Procedure: Positron Emission Tomography
Arm 3 (nivolumab, cabozantinib)ExperimentalPatients receive nivolumab IV over 30 minutes and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabozantinib S-malate; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence free survival (RFS)

    Will evaluate RFS of single agent adjuvant nivolumab plus placebo compared to the combination treatment of adjuvant nivolumab plus cabozantinib in patients with resected mucosal melanoma.

    Measured: Number of days from registration until either local or distant recurrence or death (due to any cause), assessed up to 5 years

Secondary outcomes (6)

  1. Overall survival (OS)

    Will be evaluated utilizing the Kaplan-Meier (KM) method and, when appropriate, cox proportional hazards models. Median OS is calculated (along with 95% Confidence intervals) using the KM method. A Cox proportional hazards model is built to compare arms 1 and 2 with respect to OS.

    Measured: Number of days from registration until death (due to any cause, assessed up to 5 years

  2. RFS

    Median RFS will be calculated (along with 95% Confidence intervals) using the KM method. A Cox proportional hazards model will also be built to compare arms 1 and 2 with respect to RFS, with and without stratifying for PD-L1 categorization. For non-resected cohort, If a patient in this group has surgery, their RFS data will be censored at the time of surgery.

    Measured: Number of days from registration until either local or distant recurrence or death (due to any cause), assessed up to 5 years

  3. Progression free survival

    Will be evaluated in multiple settings utilizing the KM method and, when appropriate, cox proportional hazards models.

    Measured: Number of days from registration until either radiographic or clinical progression or death (due to any cause), assessed up to 5 years

  4. Objective response rate (Arm 3)

    Will assess this endpoint utilizing a two-stage Simon that looks to improve from a rate of 20% to 47%.

    Measured: Up to 5 years

  5. Duration of response (Arm 3)

    A KM analysis is performed to calculate the median duration of response and 95% confidence intervals are constructed.

    Measured: Time from the first evidence of response until progression, assessed up to 5 years

  6. Incidence of adverse events

    The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ adverse events will be summarized.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start11 Aug 2022
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
101 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05111574
Sponsor's protocol ID
NCI-2021-11794
Other IDs
NCI-2021-11794, A091903, A091903, U10CA180821
Status last verified
Jul 2026
First submitted
5 Nov 2021
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Scan and Cabozantinib S-malate in people with Anal Melanoma and Bladder Melanoma, run by National Cancer Institute (NCI) at 146 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 69 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free survival (RFS) (time frame: Number of days from registration until either local or distant recurrence or death (due to any cause), assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05111574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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