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New drug cocktail aims to prevent rare melanoma recurrence

NCT ID NCT05111574

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 05, 2026 · Updated 6 times

Summary

This phase II trial tests whether adding cabozantinib to the immunotherapy drug nivolumab can prevent mucosal melanoma from returning after surgery. About 101 patients with resected mucosal melanoma will receive either nivolumab alone or nivolumab plus cabozantinib. The study aims to see if the combination improves recurrence-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab and cabozantinib
What this could lead to
If successful, this combination could help prevent mucosal melanoma from returning after surgery.
What could go wrong
This is a phase II trial with only 101 participants, so results are preliminary. The drugs may cause side effects like fatigue, high blood pressure, or immune reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 101 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anal melanoma cervix melanoma esophageal melanoma gallbladder melanoma melanoma mucosal melanoma rectum malignant melanoma urethra cancer vaginal melanoma vulvar melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal melanoma Bladder melanoma Cervical melanoma Esophageal melanoma Gallbladder melanoma Head and neck mucosal melanoma Mucosal melanoma Nasopharyngeal mucosal melanoma Oral cavity mucosal melanoma Penile mucosal melanoma Rectal melanoma Recurrent mucosal melanoma Sinonasal mucosal melanoma Urethral melanoma Urinary system mucosal melanoma Vaginal melanoma Vulvar melanoma

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704, United States

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090, United States

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009, United States

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405, United States

  • Billings Clinic Cancer Center

    Billings, Montana, 59101, United States

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715, United States

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017, United States

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007, United States

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115, United States

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526, United States

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505, United States

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401, United States

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938, United States

  • Carle at The Riverfront

    Danville, Illinois, 61832, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801, United States

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711, United States

  • Community Medical Center

    Missoula, Montana, 59804, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503, United States

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085, United States

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120, United States

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677, United States

  • Crossroads Cancer Center

    Effingham, Illinois, 62401, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435, United States

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220, United States

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701, United States

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031, United States

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057, United States

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Keck Medicine of USC Koreatown

    Los Angeles, California, 90020, United States

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854, United States

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864, United States

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Logan Health Medical Center

    Kalispell, Montana, 59901, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, United States

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, United States

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868, United States

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482, United States

  • Mary Greeley Medical Center

    Ames, Iowa, 50010, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • McFarland Clinic - Ames

    Ames, Iowa, 50010, United States

  • McFarland Clinic - Boone

    Boone, Iowa, 50036, United States

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129, United States

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158, United States

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501, United States

  • Memorial Medical Center

    Modesto, California, 95355, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433, United States

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331, United States

  • Miami Valley Hospital

    Dayton, Ohio, 45409, United States

  • Miami Valley Hospital North

    Dayton, Ohio, 45415, United States

  • Miami Valley Hospital South

    Centerville, Ohio, 45459, United States

  • Mills Health Center

    San Mateo, California, 94401, United States

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080, United States

  • Munson Medical Center

    Traverse City, Michigan, 49684, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422, United States

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026, United States

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045, United States

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301, United States

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538, United States

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065, United States

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086, United States

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416, United States

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640, United States

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409, United States

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560, United States

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504, United States

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706, United States

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605, United States

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687, United States

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914, United States

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301, United States

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154, United States

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303, United States

  • Saint Vincent Hospital Cancer Center at Sheboygan

    Sheboygan, Wisconsin, 53081, United States

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495, United States

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670, 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

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304, United States

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602, United States

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816, United States

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403, United States

  • Sutter Roseville Medical Center

    Roseville, California, 95661, United States

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589, United States

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503, United States

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263, United States

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

    Clive, Iowa, 50325, 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

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California, 92663, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • United Hospital

    Saint Paul, Minnesota, 55102, United States

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

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

    Miami, Florida, 33136, United States

  • University of Michigan Health - West

    Wyoming, Michigan, 49519, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, 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

  • Upper Valley Medical Center

    Troy, Ohio, 45373, United States

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235, United States

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

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