Is NCT05384496 recruiting in New York, NY?

Yes, NCT05384496 is currently recruiting participants at its New York, NY location. This mucosal melanoma clinical trial is actively enrolling qualified participants.

How do I join the mucosal melanoma clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Mucosal Melanoma Clinical Trial in New York, NY

About This Mucosal Melanoma Study in New York

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. The researchers think the drugs may be more effective if given in combinatio

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion 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. vulvovaginal, urethral) sites.

Measurable disease

Initial study entry: Subjects 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 subjects 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 after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. \[Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\] Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 31 weeks after receipt of the final dose of investigational product. Acceptable methods of effective contraception are described in the following:

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).

Exclusion Criteria

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.

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 urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of the first dose of study drug(s).

Genetic or autoimmune condition causing heightened radio sensitivity.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT05384496) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mucosal Melanoma Treatment Options in New York, NY

If you're searching for mucosal melanoma treatment options in New York, NY, this clinical trial (NCT05384496) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced mucosal melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mucosal melanoma clinical trials near you to find additional studies recruiting in your area.

Mucosal Melanoma Clinical Trial in New York, NY

Expert Care in New York

IRB Approved

No-Cost Care

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