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NCT05111574Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 4 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
101 (estimated)
First submitted
5 Nov 2021
Start date
11 Aug 2022
Primary completion date
15 Jul 2027
Lead sponsor
National Cancer Institute (NCI)
Diseases
Melanoma
NCT number
NCT05111574

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 101
  • From 11 Aug 2022 to the primary completion date, 15 Jul 2027
  • 146 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (146)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Jewish General Hospital
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MontrealCanadaUnknown status
Ottawa Hospital and Cancer Center-General Campus
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OttawaCanadaUnknown status
University Health Network, Princess Margaret Hospital
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TorontoCanadaUnknown status
Odette Cancer Centre, Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Mary Greeley Medical Center
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AmesUnited StatesUnknown status
McFarland Clinic - Ames
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AmesUnited StatesUnknown status
Community Hospital of Anaconda
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AnacondaUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesUnknown status
Sutter Auburn Faith Hospital
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AuburnUnited StatesUnknown status
Rush-Copley Medical Center
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AuroraUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Aventura
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AventuraUnited StatesUnknown status
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesUnknown status
Bronson Battle Creek
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Battle CreekUnited StatesUnknown status
Alta Bates Summit Medical Center-Herrick Campus
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BerkeleyUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
McFarland Clinic - Boone
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BooneUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Minnesota Oncology - Burnsville
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BurnsvilleUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Caldwell
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CaldwellUnited StatesUnknown status
Hematology Oncology Associates of CNY at Camillus
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CamillusUnited StatesUnknown status
Miami Valley Hospital South
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CentervilleUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Good Samaritan Hospital - Cincinnati
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CincinnatiUnited StatesUnknown status
MetroHealth Medical Center
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ClevelandUnited StatesUnknown status
Case Western Reserve University
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ClevelandUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesUnknown status
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Coral GablesUnited StatesUnknown status
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Dayton Physician LLC - Englewood
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DaytonUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Premier Blood and Cancer Center
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DaytonUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Deerfield BeachUnited StatesUnknown status
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesUnknown status
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesUnknown status
Hematology Oncology Associates of Central New York-East Syracuse
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East SyracuseUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
HSHS Sacred Heart Hospital
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Eau ClaireUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
The Melanoma and Skin Cancer Institute
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EnglewoodUnited StatesUnknown status
Parkland Health Center - Farmington
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FarmingtonUnited StatesUnknown status
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesUnknown status
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesUnknown status
Palo Alto Medical Foundation-Fremont
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FremontUnited StatesUnknown status
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesUnknown status
Northwestern Medicine Glenview Outpatient Center
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GlenviewUnited StatesUnknown status
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Northwestern Medicine Grayslake Outpatient Center
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GrayslakeUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Saint Vincent Hospital Cancer Center at Saint Mary's
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Green BayUnited StatesUnknown status
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesUnknown status
Miami Valley Cancer Care and Infusion
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GreenvilleUnited StatesUnknown status
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
McFarland Clinic - Jefferson
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JeffersonUnited StatesUnknown status
Bronson Methodist Hospital
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KalamazooUnited StatesUnknown status
Beacon Kalamazoo Cancer Center
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KalamazooUnited StatesUnknown status
West Michigan Cancer Center
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KalamazooUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesUnknown status
Northwell Health/Center for Advanced Medicine
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Lake SuccessUnited StatesUnknown status
Cancer Centers of Southwest Oklahoma Research
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LawtonUnited StatesUnknown status
Keck Medicine of USC Koreatown
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Los AngelesUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Los Angeles General Medical Center
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Los AngelesUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesUnknown status
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesUnknown status
NYU Langone Hospital - Long Island
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MineolaUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Marshfield Medical Center - Minocqua
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MinocquaUnited StatesUnknown status
Community Medical Center
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MissoulaUnited StatesUnknown status
Memorial Medical Center
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ModestoUnited StatesUnknown status
Trinity Health Muskegon Hospital
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MuskegonUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesUnknown status
USC Norris Oncology/Hematology-Newport Beach
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Newport BeachUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Corewell Health Lakeland Hospitals - Niles Hospital
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NilesUnited StatesUnknown status
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Norton ShoresUnited StatesUnknown status
Saint Vincent Hospital Cancer Center at Oconto Falls
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Oconto FallsUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Ontario
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OntarioUnited StatesUnknown status
Northwestern Medicine Orland Park
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Orland ParkUnited StatesUnknown status
Palo Alto Medical Foundation Health Care
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Palo AltoUnited StatesUnknown status
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
UPMC Hillman Cancer Center
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PittsburghUnited StatesUnknown status
UM Sylvester Comprehensive Cancer Center at Plantation
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PlantationUnited StatesUnknown status
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesUnknown status
Rapid City Regional Hospital
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Rapid CityUnited StatesUnknown status
Corewell Health Reed City Hospital
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Reed CityUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesUnknown status
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesUnknown status
North Memorial Medical Health Center
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RobbinsdaleUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
Sutter Roseville Medical Center
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RosevilleUnited StatesUnknown status
Sutter Medical Center Sacramento
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SacramentoUnited StatesUnknown status
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesUnknown status
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesUnknown status
California Pacific Medical Center-Pacific Campus
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San FranciscoUnited StatesUnknown status
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesUnknown status
Mills Health Center
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San MateoUnited StatesUnknown status
Palo Alto Medical Foundation-Santa Cruz
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Santa CruzUnited StatesUnknown status
Sutter Pacific Medical Foundation
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Santa RosaUnited StatesUnknown status
Saint Vincent Hospital Cancer Center at Sheboygan
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SheboyganUnited StatesUnknown status
Avera Cancer Institute
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Sioux FallsUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Missouri Baptist Medical Center
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St LouisUnited StatesUnknown status
Saint Vincent Hospital Cancer Center at Sturgeon Bay
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Sturgeon BayUnited StatesUnknown status
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesUnknown status
Palo Alto Medical Foundation-Sunnyvale
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SunnyvaleUnited StatesUnknown status
Munson Medical Center
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Traverse CityUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
Sutter Solano Medical Center/Cancer Center
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VallejoUnited StatesUnknown status
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status
Asplundh Cancer Pavilion
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Willow GroveUnited StatesUnknown status
University of Michigan Health - West
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WyomingUnited StatesUnknown status
Rush-Copley Healthcare Center
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YorkvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.