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New treatment option for Mucosal Melanoma
Official title Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
ClinicalTrials.gov ID: NCT05384496
What this study is testing
What is Nivolumab and/or Ipilimumab?
Nivolumab and/or Ipilimumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for mucosal melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are doing this study to find out whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma that has not been treated before. The researchers think that a combination of axitinib and nivolumab may help people with this disease because both drugs target and block proteins that play a role in cancer cell survival and growth.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologic diagnosis of unresectable or advanced mucosal melanoma arising from the head/neck (e.g. sinonasal, oral cavity, conjunctival)...
- Measurable disease
- Initial study entry: people must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST...
- Triplet arms: assessable disease required. RECIST 1.1 measurable disease is not required.
- Prior therapy
You likely can't join if
- Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\>10 mg daily of prednisone equivalents) or...
- History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain- Barre Syndrome, Myasthenia Gravis).
- History of myocarditis.
- History of, or any active evidence of non-infectious pneumonitis
- Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as...
- Cardiovascular disease, including:
See the full eligibility criteria
- Histologic diagnosis of unresectable or advanced mucosal melanoma arising from the head/neck (e.g. sinonasal, oral cavity, conjunctival), gastrointestinal (e.g. anorectal, esophageal), or genitourinary (e.g...
- Measurable disease
- Initial study entry: people must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).
- Triplet arms: assessable disease required. RECIST 1.1 measurable disease is not required.
- Prior therapy
- Initial study entry: No prior systemic therapy (adjuvant or metastatic).
- Triplet arms: Only prior systemic therapy is nivolumab + axitinib on this trial.
- ECOG performance status of 0-2.
- Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed.
- Screening laboratory parameters:
- White blood cell (WBC) count ≥ 2000/μL;
- Absolute neutrophil count (ANC) ≥ 1500/μL;
- Platelets ≥ 100,000/μL;
- Hemoglobin (Hgb) ≥ 9 g/dL;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);
- Total bilirubin ≤ 1.5 × ULN (\< 3 mg/dL for people with Gilbert's disease);
- Estimated glomerular filtration rate (GFR) ≥ 30 mL/min;either Cockcroft Gault or a cancer-specific GFR Model such as the camGFR version 2 can be used;
- Age ≥ 18 years.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks...
- Barrier Methods (Male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide).
- Intrauterine Device Methods (Copper T, or Levonorgestrelreleasing intrauterine system (e.g., Mirena®), also considered a hormonal method).
- Hormonal Methods (Implants, hormone shot or injection, combined pill, mini pill, or Patch).
- 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...
- History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain- Barre Syndrome, Myasthenia Gravis).
- History of myocarditis.
- History of, or any active evidence of non-infectious pneumonitis
- Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
- Cardiovascular disease, including:
- 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.
- Current Class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Treatment-refractory hypertension defined as a blood pressure of systolic \>150 mmHg and/or diastolic \>90 mmHg despite adequate attempts at antihypertensive therapy.
- Underlying hematologic issues including:
- Congenital bleeding diathesis
- GI bleeding requiring intervention within the past 6 months
- Active hemoptysis within 42 days prior to study enrollment
- Pulmonary emboli or deep vein thromboses (DVT) that are not stable on anticoagulation regimen.
- History of severe allergic reactions to an unknown allergen or any components of the study drugs.
- Other serious infectious illnesses (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics).
- Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a...
- Genetic or autoimmune condition causing heightened radio sensitivity.
The study team makes the final eligibility decision.
Where it's taking place
- Harrison, New York, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harrison, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.