Is NCT04697576 recruiting in Columbus, OH?

Yes, NCT04697576 is currently recruiting participants at its Columbus, OH location. This clinical stage i cutaneous melanoma ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Columbus 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.

Clinical Stage I Cutaneous Melanoma AJCC v8 Clinical Trial in Columbus, OH

Q: How do I join the clinical stage i cutaneous melanoma ajcc v8 clinical trial in Columbus?

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

About This Clinical Stage I Cutaneous Melanoma AJCC v8 Study in Columbus

This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.

Sponsor: Carlo Contreras

Who Can Participate

Inclusion Criteria

Males or females

18 to 99 years of age

Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma

At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)

Hemoglobin (Hgb) \>= 9 g/dL (drawn at or not more than 30 days prior to the screening visit)

Platelet count \>= 100 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) or =\< 5 x ULN in patients with liver metastases (Cohort 2 only) (drawn at or not more than 30 days prior to the screening visit)

Prothrombin time =\< 1.5 x ULN (drawn at or not more than 30 days prior to the screening visit)

Total bilirubin =\< 1.5 x ULN (unconjugated bilirubin of \< 3 x ULN for patients with known Gilbert syndrome) (drawn at or not more than 30 days prior to the screening visit)

Creatinine clearance of \>= 50 ml/min by Cockcroft-Gault equation (drawn at or not more than 30 days prior to the screening visit)

Women of childbearing potential (WOCBP) must agree to use effective contraceptive methods from screening until at least:

Cohort 1: 14 days after the surgical resection for subjects in Cohort 1

Nivolumab: 5 months after the last dose of either nivolumab or intralesional Flucelvax, whichever is later

Pembrolizumab: 4 months after the last dose of either pembrolizumab or intralesional Flucelvax, whichever is later

Ipilimumab: 3 months after the last dose of either ipilimumab or intralesional Flucelvax, whichever is later

Relatlimab + nivolumab (marketed under the trade name Opdualag): 5 months after the last dose of either Opdualag or intralesional Flucelvax, whichever is later.

Combination ipilimumab with other checkpoint inhibitor: Whichever is later:

3 months after the last dose of either ipilimumab or intralesional Flucelvax

Above-bulleted recommendation for nivolumab or pembrolizumab

Non-childbearing potential is defined as a woman who meets either of the following criteria: a) postmenopausal state defined as no menses for 12 months without an alternative medical cause, or b) documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy

Effective contraception methods are defined as one of the following:

True abstinence, defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject

Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception

Condoms and spermicide

Diaphragm and spermicide

Oral or implanted hormonal contraceptive

An intra-uterine device

WOCBP must have a negative pregnancy test (serum or urine)

Exclusion Criteria

Known allergy or intolerance to influenza vaccination

Subjects with condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration

Active, known or suspected autoimmune disease

Active brain metastasis or leptomeningeal metastasis

Diagnostic biopsy of ocular or mucosal melanoma

Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted

Incarcerated patients

Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (≥ 350 mm\^3), and serum HIV viral load of \< 25,000 IU/ml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria

Pregnant or lactating patients

Patients incapable of independently providing consent

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 Columbus?

Yes, this clinical trial (NCT04697576) has an active research site in Columbus, OH 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.

Clinical Stage I Cutaneous Melanoma AJCC v8 Treatment Options in Columbus, OH

If you're searching for clinical stage i cutaneous melanoma ajcc v8 treatment options in Columbus, OH, this clinical trial (NCT04697576) 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 Columbus research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced clinical stage i cutaneous melanoma ajcc v8 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 clinical stage i cutaneous melanoma ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Clinical Stage I Cutaneous Melanoma AJCC v8 Clinical Trial in Columbus, OH

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